In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

©2012 An Inconvenient Woman. All Rights Reserved.

Genital warts (condyloma) are small, fleshy growths that are found on the skin in the genital region. Most warts are painless, and many people don’t realize they have them. Occasionally, they spread and enlarge, looking like very tiny cauliflowers. The warts may be raised or reddened. Warts may sometimes also hurt or cause itching. They may grow on the large and small lips surrounding the vagina (vulva), around the anus, or on the urethra, cervix, vagina, rectum, bladder, penis, or scrotum. Genital warts vary greatly in size, color, shape, and texture, depending on where they are found.

What causes genital warts?

Genital warts are caused by human papillomavirus (HPV). Both men and women can be infected with HPV. Genital HPV is usually spread through sexual contact when the virus enters the body through small cuts or breaks in the skin. Following a short incubation period of several weeks or months, the virus may cause a wart to grow on the skin.

How common is HPV?

HPV is very common. Most men and women who have had sex get HPV. Fortunately, most HPV infections go away on their own without causing any problems for the infected person. Of the many people who have HPV, only a few display genital warts. Most infected people don’t even know they have had HPV.

Is HPV infection serious?

Some people are especially worried when they learn they are infected with the HPV virus. There are lots of different kinds of HPV, and most are not serious. This is particularly true for the types of HPV that generally cause genital warts. Sometimes, however, people are infected with more than one type of HPV. Certain less common types of HPV are associated with serious problems such as cancer of the cervix, vagina, vulva, anus, penis or scrotum.

How did I get genital warts?

You probably got HPV through skin-to-skin contact with an infected person during sex. You may not have noticed genital warts on your sexual partner(s). HPV may be passed to another person even when no wart is seen. Warts on the cervix, inside the anus, vagina, or urethra are not easily seen and, therefore, some people may not know they have warts. Your partner or former partner(s) may have given you genital warts unknowingly. Most people who have HPV do not have any signs of it and do not know they have it.

What increases my chances of getting genital warts?

The more sexual partners you have, the greater your chances are of getting genital warts. Using condoms may reduce your chances of getting warts, but condoms do not always help. Your immune system also determines whether you may develop genital warts. People with poorly functioning immune systems are more likely to get warts.

How long have I had genital warts?

It is impossible to know exactly how long you have had genital warts or HPV. If you have had more than one sexual partner in your lifetime, it is impossible to tell which partner gave you HPV. Therefore, it is very hard to determine when you were infected with HPV. You may have been infected with HPV for a long time but no warts grew immediately. You also may not have noticed very small warts that have since enlarged. If you had sexual contact with an infected person who gave HPV to you, it may take a few weeks or a few months or even longer for genital warts to appear.

How are genital warts diagnosed?

Genital warts often look similar to other types of skin growths. Usually genital warts can be diagnosed after careful examination by your health care provider. To diagnose genital warts on the outside of the body, your health care provider may apply vinegar to the external genitals. This may sting slightly. The vinegar solution may temporarily cause the skin growth to appear white. Very small warts can be diagnosed by magnifying the tiny white areas with a magnifying lens or a colposcope (a type of microscope). To diagnose genital warts on the inside of the body, a colposcope is used to shine a light on and magnify the cervix, vaginal walls, or anus. Occasionally, a tiny sample of tissue, called a biopsy, needs to be collected to find out whether the growth is a genital wart or something else.

How are genital warts treated?

Fortunately there are many ways to get rid of warts or reduce the number of warts. Sometimes warts will go away without any treatment. The location, size, and number or your genital warts determine the best treatment option for you. Treatments, when necessary, may be uncomfortable. At times, local or general anesthesia is required to prevent pain during the treatment.

Treatment
Trichloroacetic acid (TCA) or Bichloroacetic acid (BCA)

How Treated
Applied once weekly by health care provider until the warts are gone.

Side Effects
Skin irritation, scars, pain

Treatment
Podofilox gel (Condylox ®)

How Treated
Applied by the patient at home twice a day for 3 consecutive days, then followed by 4 consecutive days of no therapy. Applied for a maximum of 4 weeks.

Side Effects
Skin irritation, burning, redness

Treatment
Imiquimod cream (Aldara ™)

How Treated
Applied by the patient at home. A thin layer is applied and rubbed into the warts at bedtime on Monday, Wednesday and Friday for up to 16 weeks. After it has been on the skin for 6-10 hours, it needs to be washed off using a washcloth with soap and water.

Side Effects
Local irritation, reddening, swelling, itching, skin flaking

Treatment
Podophyllin

How Treated
Applied weekly by the clinician; must wash off with soap and water in 6-8 hours

Side Effects
Burning; skin breakdown, particularly if not washed off

Treatment
Interferon

How Treated
Injections may be used for warts that do not go away

Side Effects
Flu-like symptoms; expensive

Treatment
Laser surgery (requires anesthesia)

How Treated
Burns away the wart

Side Effects
Tissue injury, pain

Treatment
Cryotherapy

How Treated
Freezes the wart. Repeat every 1-2 weeks, until cleared

Side Effects
Tissue injury, pain

Treatment
Knife or scissors (requires local anesthesia)

How Treated
Cuts off warts

Side Effects
Pain, bleeding

Treatment
LEEP (loop electroexcision procedure) (requires local anesthesia)

How Treated
Removal of tissue with an electric wire cutting procedure

Side Effects
Tissue injury, bleeding, pain

Will the warts recur after treatment?

Many warts disappear after treatment. But sometimes genital warts reappear again months or years after successful treatment. Some types of treatment may work better than others for you. No single type is always successful in treating warts in everyone.
Therefore, it is important to watch for new warts.

Why would warts come back after treatment?

Genital warts can be treated, however, currently there is no cure for the HPV infection itself. The goal of treatment is to remove the wart (skin that is that is abnormal-appearing) without damaging normal tissue around the wart. Yet normal appearing tissue surrounding the wart may also be infected with HPV. Treatment will often stimulate the body’s natural immune system to eliminate the small amount of HPV that may be left behind in the normal appearing tissue. However, a small amount of HPV in the normal skin may resist the treatment. Therefore, the remaining HPV may cause warts to return at a later time. If warts do reappear, it does not necessarily mean that you have been re-infected. New warts usually come from the same HPV that was already present in your normal appearing skin.

What should I do to take care of myself?

You may want to check yourself for the development of new warts following treatment.

• If you discover new genital warts, have them treated as soon as possible.
• Having genital warts may mean that you are at a slightly greater risk for getting
• cervical cancer.
• Women should have regular Pap tests.
• If you smoke tobacco, stop! Tobacco weakens your immune system and increases your risk for getting HPV again.
• Try to keep your stress level low, get enough sleep, and eat a nutritionally balanced diet.

How can I prevent spreading genital warts to others?

Genital warts are extremely contagious. Once the warts disappear after treatment, it is less likely that you will transmit HPV to your sexual partner. Now that you know you have genital warts, you should tell your current (and past) sexual partner(s), so that they can be examined. The virus (HPV) that causes genital warts can be transmitted through oral, anal, and vaginal sex. HPV may be present anywhere in the anal or genital area. Using condoms during vaginal or anal intercourse and dental dams during oral sex may help to reduce the chance of spreading infection. Condoms or dams may not always completely prevent the spread of HPV infection, because HPV may be in the skin that is not protected by the condom.

Will having genital warts cause problems if I become pregnant?

If you have genital warts, there is a very small chance that your baby could inhale the HPV virus while passing through the birth canal. This rarely happens, but if it did, your baby could develop warts on the vocal cords in the throat. This could cause breathing problems and would require treatment. Usually, women with genital warts have regular deliveries. If your warts were so large that they blocked the opening through which the baby must pass, then your baby would be delivered by Cesarean section.

How can I cope with genital warts?

Be sure to get regular check-ups, including Pap tests. If you see genital skin changes, make an appointment with your health care provider for an exam. It is common for people with genital warts to feel angry, upset, depressed or ashamed about their condition. These feelings are normal, but you should seek counseling if the feelings interfere with your relationships and life activities. Some women may also be concerned about the risk for cancer. Keep in mind that genital warts can be managed and cervical cancer can almost always be prevented. Talk to your health care provider about your concerns. Keeping yourself healthy and not smoking can help boost you body’s natural defense system to fight the virus.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.

These materials were developed by the American Society for Colposcopy and Cervical Pathology (ASCCP) Patient Education Committees and approved by the Board of Directors for use by patients.

This material is provided for informational purposes only. It does not constitute medical advice and is not intended to replace professional care. Please consult your health care provider with any questions or concerns you may have regarding your condition. The ASCCP National Office does not provide individual consultation on cases or diagnoses.
While you may download, print and distribute these materials freely, they are copyrighted materials and all rights are owned by ASCCP. Therefore, they may not be changed, edited or altered in any way.

©2012 An Inconvenient Woman. All Rights Reserved.

HPV, human papillomavirus, is an infection that is passed from one person to another through direct skin-to-skin contact. When genital skin (on the penis, scrotum, vulva [area near the opening to the vagina] and near the anus [rectal opening]) is involved, the infection is called “sexually-transmitted”.

There are about 100 different types of HPV. Most HPV infections do not cause any health effects at all because the infected person’s immune system gets rid of them before they can do any damage. At times certain types of HPV (“low risk”) can cause minor changes. Usually those types do not cause long term problems. But other types (“high risk”) can cause infected cells to lose control of their own growth; if early changes are not found and treated, these changes can turn into cancer years later.

Why is this important for women’s health?

HPV infection is very common. One of the sites most often infected by HPV is the genital tract. Several studies have shown that young sexually active women become infected with HPV in the genital area at the rate of 15-20% per year. When followed for three years, about 80% of women in those studies tested positive for HPV at one time or another.

When certain “low risk” types of HPV infect the outer genital skin (vulva) or cervix, they can cause genital warts (also known as condylomata acuminata) and harmless changes on the cervix. Other “high risk” types commonly infect the cervix where they can cause changes that might become cancer in the future ( dysplasia), depending on the type of HPV and the length of time the infection has lasted. If high-risk HPV infections on the cervix are not found and not treated for years, some of those infections can result in cervical cancer.  Over 4000 women die each year in the US from cervical cancer.

How is HPV infection spread?

Vaginal, oral and anal sex can all spread HPV. Many persons who have HPV do not know they have it – they can spread it to their sexual partners without knowing it. Most people who become infected with HPV have gotten it from a partner who had no symptoms at all.

How would I know if I had HPV?

Often infected women and men do not know that that they have an HPV infection. Some persons develop genital warts or condylomata acuminata which are small, raised, skin-colored or gray rough-surfaced bumps ranging from the size of sesame seeds to the size of apple seeds or even larger. They usually don’t hurt, but they may itch slightly or feel irritated. Your clinician can identify these lesions during an exam. Other persons develop HPV infections of the cervix (the lower part of the uterus, located at the top of the vagina). These infections do not produce symptoms that patients can see or feel. The only way to know about an HPV infection of the cervix is to have a Pap test or cervical HPV test performed during a pelvic exam. A Pap showing dysplasia or intraepithelial neoplasia or cervical cancer almost always is a result of
HPV infection.

What is a Pap test?

In this test, cells are scraped off the cervix and placed on a slide. A specially trained laboratory professional examines the slide and looks for abnormal cells. If abnormal cells are found, the slide is further reviewed by a pathologist. The Pap test report gives useful and important information to the clinician, helping him or her decide whether further testing is necessary if the results are abnormal.

What is an HPV test?

The HPV test is performed either from the same specimen as a Pap test, or from a separate brush sample from the cervix. It detects HPV genetic material (DNA) from the 13 types of HPV that can most commonly be associated with the development of cervical cancer. These are the “high risk” types. Most people who are infected with these types of HPV may never have any related problems. However, women who have a high-risk type of HPV are much more likely than uninfected women to develop a cervical pre-cancer (dysplasia) or cancer over time.

Which test should I get: an HPV test or a Pap test?

The most important test for every sexually-active woman to have regularly is the Pap test. If her Pap is abnormal, further testing can be done to determine the exact location and nature of the abnormality and to treat it. Early detection and treatment are highly successful at preventing cervical cancer.

Then who should get an HPV test?

The HPV test is helpful in women whose Pap test report is “ atypical squamous cells of undetermined significance”, often abbreviated as “ASC-US”. This means that the result is uncertain – it is not normal but it is also not abnormal in any precisely defined way. Some of these Pap tests with uncertain results show HPV infection on additional testing. So the HPV test can help your clinician understand the reason for the uncertain Pap. In addition, most experts believe that for women over 30, HPV testing along with a routine Pap test is the best way to screen for dysplasia or cervical cancer. This combination of testing is so reliable that if both tests are normal, the tests should be repeated only every three years.

In addition, an HPV test may be recommended as part of follow-up after an abnormal Pap test has been evaluated and possibly treated.

Why not test women under 30 for HPV with their Pap test?

HPV is so common and so unlikely to cause problems in young women that finding it isnot helpful. On the other hand, the Pap test does find cell changes thatare important to evaluate.

What if my test is negative?

A woman whose HPV DNA test is negative has only a small chance of having dysplasia or cancer at the time of the test. But she should continue to obtain regular Pap tests to detect any hidden or future infection.

What happens if my HPV test shows that I have HPV?

If you have a positive HPV test and an abnormal Pap, you will most likely be advised to undergo colposcopy. This is a procedure in which the cervix is examined using a bright light and magnification. Often a biopsy (a small pea-sized piece of tissue) is taken and sent to a pathology lab for examination. The biopsy is the most reliable test and the results of the biopsy, not the Pap or the HPV test, are used in planning the most appropriate treatment, if any.  If you have a positive HPV test and a normal Pap test, your healthcare provider will make a personal recommendation for you based on your own individual health circumstances and your past Pap and HPV history.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.
These materials were developed by the American Society for Colposcopy and Cervical Pathology (ASCCP) Patient Education Committees and approved by the Board of Directors for use by patients.

While you may download, print and distribute these materials freely, they are copyrighted materials and all rights are owned by ASCCP. Therefore, they may not be changed, edited or altered in any way.

©2012 An Inconvenient Woman. All Rights Reserved.

HPV is human papillomavirus. It is the most common viral sexually transmitted infection for both men and women. Some types of HPV are called “low risk”.

Those can infect the skin around the genitals and cause genital warts. Other types of HPV are called “high risk”. When those types infect internal genital areas they sometimes cause precancerous or cancerous changes on the cervix (opening to the uterus) or vagina. “High risk” HPV can also cause precancerous changes on the external genital areas (vulva).

How common is HPV?

HPV is very common. Most men and women who have had sex get HPV. Fortunately, many HPV infections go away on their own without causing any problems for theinfected person. Most infected people don’t even know they have had HPV.

Is HPV infection serious?

There are lots of different kinds of HPV, and most are not serious. Infection with a “low risk” virus can cause genital warts but will not produce major problems. However, sometimes “high risk” HPV infection can cause skin cells to grow abnormally. The growth may be precancerous and could eventually become a potentially serious problem, such as cancer of the cervix, vagina, vulva, or anus.

How did I get HPV?

You probably got HPV through skin-to-skin contact with an infected person during vaginal, oral, or anal sex. It is possible for a person to have HPV in skin cells and pass it on to another person even when no genital warts are present. Most people who have HPV do not have any signs of it and do not know they have it.

What about HPV and oral sex?

If a person performs oral sex on a partner with genital HPV, there is a small chance that his or her mouth can become infected. Wart-like lesions and precancers can develop in the mouth or throat. Untreated precancerous lesions in the mouth or throat can turn into cancer after a long time. If a person receives oral sex from a partner with HPV in his or her mouth, that person can possibly develop a genital HPV infection. Currently there is no screening test for oral HPV. Your healthcare provider or dentist can carefully examine your mouth to look for lesions, but it is unknown how helpful that will be in preventing HPV-related mouth or throat cancers.

What increases my chances of developing a genital HPV infection?

The more sexual partners you have, the greater your chances are of getting an HPV infection. Using condoms may reduce your chances of getting infected, but condoms do not always help because HPV can be present in areas not covered by the condom. Your immune system also determines whether you may develop a HPV infection when you are exposed. A healthy immune system keeps you from being sick. People with poorly functioning immune systems are more likely to get a HPV infection. Smoking tobacco weakens your immune system and increases your risk for getting HPV when exposed to the virus.

How long have I had HPV?

It is impossible to know exactly how long you have had HPV. If you have had more than one sexual partner in your lifetime, it is impossible to tell which partner gave you HPV. If you had sexual contact with an infected person, it usually takes a few weeks or months for genital warts to appear or for a Pap test to become abnormal. You may have had HPV for some time before it was discovered by a physical exam, abnormal Pap test, or HPV laboratory test.

How is HPV diagnosed?

HPV can be diagnosed in several ways.

• Sometimes the skin changes on external areas can be seen on physical exam.
• Many infected women first learn they have HPV when they have an abnormal Pap test.
• At times, a specific test for the HPV virus recognizes it in infected cells on the cervix. (This test is not useful on other parts of the body or in men.
• When HPV infection of the cervix or vagina or anus is suspected, your health care provider can use a colposcope to shine a light on and magnify the cervix and vaginal walls and/or the anus. Often a tiny piece of tissue (a biopsy) is taken and examined in a laboratory to check for changes produced by HPV

How is HPV treated?

Like all other virus infections, HPV infection cannot be cured with medication. Luckily, your body’s immune system can and usually does get rid of the infection and the skin changes it causes.

However, the abnormal skin growths (genital warts or precancerous changes) caused by HPV can be treated with medication or minor surgery. The type of treatment depends on the location, number, and kind of skin changes. If the virus has caused only slight abnormalities, then no treatment may be necessary at this time. Careful monitoring for future changes with self-examination, regular Pap tests, or possible colposcopy may be necessary. If more severe skin abnormalities are found, they often need to be treated.

There are many ways that your health care provider can treat abnormal areas. Some treatment can be done at home, and other types of treatment must be done in the clinic. Your health care provider will discuss these treatment options with you.

Will I still have HPV after treatment?

There is no cure for HPV. The goal of treatment is to remove the abnormal area that contains the virus without causing damage to the normal, healthy tissue surrounding the abnormal area. It is likely that a small amount of virus will remain after treatment. Often your body’s immune system can take care of the remaining virus.

How can I prevent spreading HPV to others?

You can reduce the chance that you will share your HPV infection with other people by having any abnormal skin or genital warts treated until they are gone. Using condoms during sexual intercourse and dental dams during oral sex may also help to reduce the spread of infection. However, condoms or dams may not always completely prevent the spread of HPV infection, because HPV may be in skin that is not protected by the condom or dam. Now that you know you have HPV, you should tell your current (and past) sexual partner(s), so that they can be examined and treated, if appropriate.

Will having HPV cause problems if I become pregnant?

Problems caused by HPV in pregnancy are unlikely. There is a very small chance that your baby could catch HPV from you. The baby could inhale HPV-infected cells from your birth canal during birth. Although it rarely happens, the baby’s vocal cords can become infected with the virus. This could cause breathing problems and would require treatment. Usually, women with HPV have regular vaginal deliveries. Only women who have very large genital warts that block the birth canal need a Cesarean section because of the HPV infection.

What should I do to take care of myself?

• You may want to check yourself for the development of new warts following treatment.
• If you discover new genital warts, have them treated as soon as possible.
• Having genital warts may mean that you are at a slightly greater risk for getting
• cervical cancer.
• Women should have regular Pap tests.
• If you smoke tobacco, stop!
• Try to keep your stress level low, get enough sleep, and eat a nutritionally
• balanced diet.
• If you are a woman between the ages of 9 and 26, ask your healthcare provider whether you should get the HPV vaccine. Even if you have already been infected with one type of HPV, the vaccine will prevent infection with other types.

How can I cope with HPV?

Be sure to get regular check-ups, including Pap tests. If you see genital skin changes, make an appointment with your health care provider for an exam. These feelings are normal. It is common for people with HPV to feel angry, upset, depressed or ashamed about their condition. Some women may also be concerned about the risk for cancer. Keep in mind that HPV can be managed and cervical cancer can almost always be prevented. Talk to your health care provider about your concerns. Keeping yourself healthy and not smoking can help boost you body’s natural defense system to fight the virus.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.
These materials were developed by the American Society for Colposcopy and Cervical Pathology (ASCCP) Patient Education Committees and approved by the Board of Directors for use by patients.

While you may download, print and distribute these materials freely, they are copyrighted materials and all rights are owned by ASCCP. Therefore, they may not be changed, edited or altered in any way.

©2012 An Inconvenient Woman. All Rights Reserved.

A recent press release from Roswell Park Cancer Institute (RPCI) in Buffalo, New York caught my attention. I have been following the HPV-vaccine debate since 2005. I’ve read thousands of press releases, research papers, articles and websites. I’ve observed what I consider an interesting information interpretation phenomenon. Two or three research bodies can look at the same set of data and come to several, sometimes diametrically opposed conclusions. I think it is important to read everything, even the material I don’t agree with — actually, especially the information I don’t agree with. Insight is always helpful, even if I disagree with the conclusion.

Several recent studies have pointed to an increased incidence of cancers of the head and neck. A decade or so ago the network news executives decided that the sexual preference of a sitting president was fine six o’clock news fare. Along with the great debate of what the meaning of “IS” is, the notion that oral sex wasn’t sex came into the national consciousness. Followed quickly by reports from news broadcasters that increasing numbers of middle school kids had been observed on both school bus and school security cameras engaging in oral sex.

What ‘IS’, is. As oral sex became an “accepted” practice of being sexually active while maintaining “technical virginity” incidences of oral HPV infections in teens and young adults grew to the point, that the trend was noted by STD researchers.

Today a number of those researchers have concluded that certain cancers of the head and neck are strongly linked to HPV 16, a specific strain of the human papillomavirus (HPV). According to Thom Loree, MD, Chair of RPCI’s Department of Head & Neck Surgery the types of cancer associated with HPV 16 occur mostly at the back (base) of the tongue, in the tonsils, and in the soft palate at the back of the throat. Over the past 10 years, members of RPCI’s Head & Neck Department have seen a threefold increase in the number of throat cancers they treat.

In 2007, Roswell Park researchers began testing all head and neck tumors treated at the Buffalo-based comprehensive cancer center for the presence of HPV DNA, says Saurin Popat, MD, FRCSC, FACS, Attending Surgeon in Head & Neck and Plastic & Reconstructive Surgery, RPCI. RPCI is one of few institutions in the nation to do so. Data from the ongoing testing have been combined with data from archived tumor samples to provide a clearer picture of how many head and neck cancers treated at RPCI test positive for HPV. To date, the total is around 50 to 60 percent.

The American Cancer Society estimates that 35,310 new cases of oral and oropharyngeal cancer are diagnosed every year—25,310 of those in men—and 7,590 people, including 5,210 men, die of those cancers. The American Cancer Society still implicates smoking, the use of chewing tobacco, and heavy alcohol use as the leading causes of cancers of the head and neck. The resent RPCI HPV research may change that view, or not.

Human papillomavirus (HPV) that is one of the most common sexually transmitted diseases in the United States. It is estimated that approximately 70% of Americans, both men and women, will be infected with HPV at some point in their lives. RPCI researchers compared HPV with the common cold. There is no cure for HPV, just as there is no cure for the common cold. In most people, those with a healthy lifestyle and a resilient immune system, an HPV infection will resolve on its own, but it can be passed on to other people during the infection period — just as with the common cold.

There are more than 100 identified, numbered, types of HPV—but only 70 have been described so far. Some HPV viruses, including 16 and 18, are transmitted sexually—not just through sexual intercourse, but also through any skin-to-skin contact involving the mouth, vagina, vulva (the external female genitalia), penis, anus, or fingers.

HPV 16 and HPV 18 were previously identified as the cause of most cases of cervical cancer in the U.S. HPV has also been implicated in the development of some cancers of the vulva, vagina, anus, penis, and perineum (the area between the genitals and anus).

In some cases, the person may continue to be infected for decades without any symptoms. During that time, the infected person can infect others without knowing it. Over time, this “silent,” chronic HPV infection increases the risk of developing certain cancers.

In 2006, the FDA approved the use of the HPV vaccine, Gardasil, for girls and young women ages 9 through 26. The rational for vaccinating school girls was to protect them from the HPV 16 and HPV 18 identified as the cause of most cases of cervical cancer; and immunize them from HPV 6 and HPV 11 which can result in the STD, genital warts, BEFORE they were exposed to HPV through sexual contact.

The Merck & Co, INC Gardasil product sheet gives some valuable doctor/patient information.

However, it is supplied on an 11 X 22” sheet, printed both sides, using 6-point Helvetica light, justified type, print production speak for really hard to read. The sheet is folded down to approximately 2.75 X 5.50-inches, and glued into the marketing brochures Merck’s drug reps leave in Doctor’s offices.  The important information, to which I refer, is in the section called:
EFFICACY IN SUBJECTS WITH CURRENT OR PRIOR INFECTION
GARDASIL is a prophylactic vaccine

• There was no clear evidence of protection from disease caused by HPV types which subjects were PCR positive and/or seropositive at baseline.

• Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical diseases by the remaining vaccine HPV types.

So this brings me back to my original quandary concerning the red hot hurry to vaccinate all schoolgirls.

The Merck Gardasil Product sheet states in the section:
WHAT OTHER KEY INFORMATION ABOUT GARDASIL SHOULD I KNOW?

• This vaccine will not protect you against HPV Types to which you may have already been exposed.
• 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, 18)

To me the first question we all should be asking before vaccinating is:

How many schoolgirls have already been exposed to the HPV 16 and HPV 18 and HPV 6 and HPV 11?

Allegedly a baby of an HPV-positive mother can be exposed to the virus during the birthing process. Children can be exposed to the HPV by skin to contact, yet another reason to wash hands well after using the restroom.  Researchers have noted that the HPV virus can lay dormant for years. Then there is the HPV exposure risk related to the increased incidence of oral sex experienced by adolescents and teenagers.

• What questions are health care professionals asking before administering the HPV-vaccine?
• Will a school nurse, or other public health care provider ask about allergies to the ingredients as required on the product information sheet?

Merck product sheet states in the Section:
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

Although how a school girl or her mother for that matter would know if she is allergic to “amorphous aluminum, hydroxyphosphate sulfate, sodium chloride. L-histidine. Polysorbate 80, and sodium borate, is beyond me.

Does the doctor offer a skin scratch to test for sensitivity before administering the shot?

There are as many unanswered questions about Gardasil in 2009 as in 2006. We have thousands of adverse effects reports reported to the CDC. Parents want to know what is happening to their daughters. So far the CDC, FDA and Merck are using the unfortunate but unrelated set of circumstances defense. The CDC still indorses the HPV vaccine as a needed inoculation.

The EU governments are starting to question the rush to vaccinate a generation. The German government is reviewing their HPV-vaccine policy right now.

Will the German scientist deciding against the HPV vaccine policy effect the CDC’s position on Gardasil?  That is a wait and see question.

The publicity around the reported HPV-adverse reactions and the revelations concerning Merck’s lobbyists  ‘carpet-cash-bombing’ federal, state and local government officials and representatives are proving to be a cautionary tale to American parents. Sales of the HPV vaccine Gardasil fell in 4-th quarter 2008 and plummeted in 1st quarter 2009. More folks are looking around and asking, “What is the Rush?”

Now this is what brings me back to the Roswell Park Cancer Institute (RPCI) May 21, 2009 press release titled “Sexually Transmitted HPV Linked to Certain Head & Neck Cancers”
Headlined:
“RPCI Researchers Say Boys Need to Be Vaccinated, Too!”

The RPCI researchers reviewed the increased head and Neck cancers and see a justification to pressure the FDA to expand the use of Gardasil to boys. The FDA has not approved the vaccine for males —yet. The issue of extending approval to males to protect against HPV related cancers is under review, with a decision expected in June 2009.
Loree, Popat, and their RPCI colleagues see compelling evidence for extending the vaccine’s protection to boys. Says Popat, “The side effects of the vaccine are so small, and the potential benefits are great.” He notes that patients with throat cancer “have to undergo major treatment lasting several months, with an additional four to six months of recovery. Their ability to speak and swallow is affected. Generally, they do very well; however, it is a long, challenging road.”

The RPCI’s Loree says that “with increased vaccination against HPV, you’ll see a decrease in cervical cancer and in throat cancers.” He says if everyone stopped smoking and using tobacco in any form, and also got vaccinated against HPV, “we could eliminate head and neck cancers, and I’d be out of business.”

I guess the passing nod to dipping and other tobacco related damage is a scientific homage to the American Cancer Society’s figures that indicate tobacco and alcohol use as the primary cause of throat cancers.

I find the Roswell Park Cancer Institute (RPCI) research compelling. They are dedicated scientist vested in fighting a dreaded disease and I respect their process.  Their stated goal is to banish all cancer. So far we are totally on the same page. I went to their website to find out more about the organization.

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

However, I still want to know who funded the study.

If the conclusion was to recommend the FDA expanding the HPV-vaccine to boys, we need to know whose money was funding the study.

I’ve emailed RPCI and asked the question.

I’ll let you know as soon as I receive an answer.

Inconvenient Women trust, but personally verify.

©2012 An Inconvenient Woman. All Rights Reserved.

Good. We want reader engagement, even reader ‘enragement’.

Most of all we want you burning up the resource documents provided, building your personal knowledge base, the private touch stone you consult before you agree to a new medicine, procedure or operation.

Based on recent comments to my Blog, I counted the number of entries I had posted concerning cervical cancer; thus far, 97 Inconvenient Woman Blogs have dealt with some aspect of this disease.

The sources for these articles are varied. I have taken information concerning cervical cancer from the Centers for Disease Control, Cancer Prevention and Control (CDC), the Food and Drug Administration (FDA), The U.S. Department of Health and Human Services, Office of Women’s Health (http://www.womenshealth.gov), the American Cancer Society, Cancer Research Foundation of America, American Society of Clinical Oncology, National Cancer Institute, WebMD, WrongDiagnosis.com, New England Journal Of Medicine, JAMA, the Journal of the American Medical Association, transcripts from the Public Broadcasting Service (PBS) including articles and OPED pieces written by  health care professionals, medical journalists, Pharma Industry pundits, critics and true believers.

I have always considered IconicWoman.com and my Blog, An Inconvenient Woman as an aggregator of women’s health information and issues. The Iconic Woman Project was initiated to disseminate health-related information that effects women and girls not regularly reported or analyzed by the mainstream press. My goal is to identify information of interest, poses questions and provide source documentation for my readers to pursue your own research and the resources to help you take action.

The Inconvenient Woman article archive offers transformative, educational information to improve your relationship with your body and yourself; and provides articles that will help readers expand your current perspective, and encourage you to take a more proactive stance concerning your health. The purpose of Iconic Woman is to Activate more Inconvenient Women. Women who ask questions, demand answers, verify answers with an independent source, make informed decisions and pro-actively participate in their personal health and well-being. Education and the willingness to ask questions and demand answers is a start. It is imperative that women be proactive in all aspects of our wellness.

The following description  of  “What Causes Cervical Cancer” is reprinted with permission from Health Information Publications.

What Causes Cervical Cancer?

We don’t know exactly what causes cervical cancer, but certain risk factors are believed to have an effect. Medical history and lifestyle – especially sexual habits – play a role in a woman’s chances of developing cervical cancer.

The most significant risk factors are:

• Human papillomavirus (HPV)
• Sexual history

Various other risk factors have also been identified.

Human Papilloma Virus (HPV)

Human papillomavirus (HPV) is a virus that can infect:

• The genital tract
• The external genitals
• The area around the anus

HPV has nothing to do with HIV, the virus that causes AIDS. There are 46 genetic types of HPV, but not all are dangerous. Only certain types of HPV, which can be transmitted from one person to another during sexual contact, increase the risk of cell dysplasia (abnormal cell growth) and/or progression to cervical cancer.

The HPV types that produce genital warts (lesions that are raised and bumpy, or flat and almost impossible to see) are different from those that cause cervical cancer. However, women who have a history of genital warts have almost twice the risk of an abnormal Pap smear as other women.

Sexual History

A woman has a higher-than-average risk of developing cervical if she:

• Has had multiple sexual partners
• Began having sexual relations before the age of 18
• Has a partner who has had sexual contact with a woman with cervical cancer

Other Risk Factors

It is probable that other factors contribute to cervical cancer, such as:

• Poverty. Women who are poor may not have access to medical services that detect and treat precancerous cervical conditions. When such women develop cervical cancer, the disease usually remains undiagnosed and untreated until it has spread to other parts of the body. Women who are poor are often undernourished, and poor nutrition can also increase cervical cancer risk.
• Pap test history. Not having regular Pap tests increases the chance of unrecognized cervical cancer. Between 60% and 80% of women with newly diagnosed cervical cancer have not had a Pap test in at least five years.
• Tobacco use. Women who smoke are about twice as likely to develop cervical cancer as women who do not. The more a woman smokes – and the longer she has been smoking – the greater the risk.
• Eating habits. A diet that doesn’t include ample amounts of fruits and vegetables can increase a woman’s risk of developing cervical cancer.
• Weakened immune system. A woman whose immune system is weakened has a higher-than-average risk of developing cervical lesions that can become cancerous. This includes women who are HIV-positive (infected with the virus that causes AIDS). It also includes women who have received organ transplants and must take drugs to suppress the immune system so that the body won’t reject the new organ.For more detailed information about AIDS, go to AIDS And Women.

• Hormonal medications. Some experts suggest that hormones in oral contraceptives (birth control pills) can make women more susceptible to Human papillomavirus (HPV). At least one study has indicated that taking birth control pills significantly increases a woman’s risk of developing HPV-related genital warts. Other research suggests that using oral contraceptives for five years or longer slightly elevates a woman’s risk of developing cervical cancer, especially if she began taking the Pill before the age of 25.
• Diethylstilberstrol (DES). A rare type of cervical cancer has been diagnosed in a small number of women whose mothers took diethylstilbestrol (DES), a medicine that was once used to prevent miscarriage.
• Douching. Because douching may destroy natural antiviral agents normally present in the vagina, women who douche every week are more apt to develop cervical cancer than women who do not.
• Chemical exposure. Women who work on farms or in the manufacturing industry may be exposed to chemicals that can increase their risk of cervical cancer.

Women with a weakened immune system due to the virus that causes AIDS are more likely to develop cervical cancer:

• Cervical cancer is very common in women who are positive for human immunodeficiency virus (HIV).
• Cervical cancer is sometimes the disease that first suggests a diagnosis of acquired immunodeficiency syndrome (AIDS)
• HIV can compound the effects of Human papillomavirus (HPV), causing cervical changes to progress more rapidly into cervical cancer than they otherwise might.

Reprinted with permission from Health Information Publication. All Text and images in this post are protected by Copyright © 2002-2005 Health Information Publications. The information provided on this Web site has been developed exclusively by and for Health Information Publications and ehealthMD and may not be copied without written permission. The information provided is for general information only and is not intended to replace the advice of your health-care provider. This is original material developed by Health Information Publications, Copyright © 1990-2005

©2012 An Inconvenient Woman. All Rights Reserved.

Merck’s award winning marketing campaign for their HPV-vaccine, Gardasil, was designed to instill a sense of urgency, the need to protect girls from the clear and imminent danger of cervical cancer. Cancer, like FIRE, is one of those words that never should be yelled in a crowd, because panic ensues. The word cancer has a whole slide tray of images that involve pain, medical processes, and lingering death. A “good” parent would protect their child from cancer.  A concerned parent would immediately call their family doctor and get their daughter the Gardasil, HPV-vaccine to protect her from the scourge  of cervical cancer. This marketing campaign, combined with a Blitzkrieg political lobbing effort managed to get Gardasil approved, mandated by several States and in the bodies of young women everywhere, before a lot of questions were asked, let alone answered.

Is Gardasil really the right answer?

The first question  a parent should ask,  “Is this shot necessary?” Do your own research an come to an informed decision, not one based on an impression formed by a slick marketing campaign.

“Is this shot safe?” My personal opinion is no; but that is a question for each parent to conduct his or her own risk/benefit analysis. All I know for sure, and I get my statistical information from the CDC, the same agency that promotes the use of the HPV vaccine,  Gardasil, that it is not the only way to protect our daughters. According to CDC literature, the PAP test is still the best way to detect Cervical cancer early and cervical cancer is the easiest cancer to cure non-invasively. Based on the FDA recalls of the past decade, a reasonable ‘lesson-learned’ is that any time foreign substance are introduced to the immune system and opportunity for failure exists.

Why take the risk is there is a proven, safe alternative?

These Cervical cancer statistics are from the Center for Disease Control, taken from their website with no additions or editing. Please note that these statistics were extrapolated in 2005, that is before the HPV vaccine Garadasil was approved by the FDA.  (2005 is the latest available don’t ask me why, that is another Blog.)

CDC Cervical Cancer Statistics

Related Information: Compare by Race and Ethnicity, Compare by State, HPV-Associated Cervical Cancer Statistics

Cervical cancer used to be the leading cause of cancer death for women in the United States. However, in the past 40 years, the number of cases of cervical cancer and the number of deaths from cervical cancer have decreased significantly. This decline largely is the result of many women getting regular Pap tests, which can find cervical precancer before it turns into cancer.¹ According to the U.S. Cancer Statistics: 2005 Incidence and Mortality Web site, 11,999 women in the U.S. were told that they had cervical cancer in 2005,* and 3,924 women died from the disease.² It is estimated that more than $2 billion^† is spent on the treatment of cervical cancer per year in the U.S.³ The number of women in the U.S. who develop or die from cervical cancer each year varies by state. Find more information about cervical cancer rates by state.

Statistical Trends

The rates for new cervical cancer cases (incidence) have decreased steadily across multiple racial and ethnic groups, as follows:⁴

• 3.6% decrease per year from 1996 to 2005 among all women.
• 3.5% decrease per year from 1996 to 2005 among white women.
• 5.0% decrease per year from 1996 to 2005 among African-American women.
• 5.3% decrease per year from 1996 to 2005 among Asian/Pacific Islander women.
• 4.2% decrease per year from 1996 to 2005 among Hispanic women.

In most racial and ethnic groups in the U.S., the rates for cervical cancer deaths (mortality) also have been decreasing as follows:⁴

• 3.4% decrease per year from 1995 to 2005 among all women.
• 3.2% decrease per year from 1996 to 2005 among white women.
• 4.3% decrease per year from 1996 to 2005 among African-American women.
• 5.2% decrease per year among Asian/Pacific Islander women.
• 3.1% decrease per year from 1996 to 2005 among Hispanic women.
• No change from 1996 to 2005 among American Indian/Alaska Native women.^‡

Even though these trends suggest that cervical cancer incidence and mortality continue to decrease significantly overall, and for women in some racial and ethnic populations, the rates are considerably higher among Hispanic and African-American women. Find more information about cervical cancer rates by race and ethnicity.

*The most recent year for which statistics are available. ^†The cost estimates were originally presented in 1996 U.S. dollars, which were updated to 2000 U.S. dollars using the Medical Care Component of the Consumer Price Index [MCPI]. ^‡Any change in the rate recorded for this group was not statistically significant.

References

1. Cervical Cancer. NIH Consensus Statement. April 1–3 1996;14(1):1–38.
2. U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2009. Available at: http://www.cdc.gov/uscs.
3. Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: economic cost and quality of life. Annual Review of Public Health 2001;22:91–113.
4. Ries LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer Statistics Review, 1975–2005, National Cancer Institute. Bethesda, MD, based on November 2007 SEER data submission, posted to the SEER Web site, 2008.

©2012 An Inconvenient Woman. All Rights Reserved.

Regular PAP Tests are the Best Defense Against Cervical Cancer

Cervical cancer is the easiest female cancer to prevent, with regular screening tests and follow-up. Two tests can help prevent cervical cancer or find it early:

• The Pap test (or Pap smear) looks for precancers, cell changes on the cervix that might become cervical cancer if they are not treated appropriately.
• The HPV test looks for the virus that can cause these cell changes.

The Pap test is recommended for all women, and can be done in a doctor’s office or clinic. During the Pap test, the doctor will use a plastic or metal instrument, called a speculum, to widen your vagina. This helps the doctor examine the vagina and the cervix, and collect a few cells and mucus from the cervix and the area around it. The cells are then placed on a slide or in a bottle of liquid and sent to a laboratory. The laboratory will check to be sure that the cells are normal.

If you are getting the HPV test in addition to the Pap test, the cells collected during the Pap test will be tested for HPV at the laboratory. Talk with your doctor, nurse, or other health care professional about whether the HPV test is right for you.

When you have your Pap test, your doctor also may perform a pelvic exam, checking your uterus, ovaries, and other organs to make sure there are no problems. There are times when your doctor may perform a pelvic exam without giving you a Pap test. Ask your doctor which tests you are having, if you are unsure.

If you have a low income, or do not have health insurance, you may be able to get a free or low-cost Pap test through the National Breast and Cervical Cancer Early Detection Program. To find out if you qualify, call your local program or 1-800-CDC-INFO.

When to Get Screened

You should start getting regular Pap tests at age 21, or within three years of the first time you have sex—which ever happens first. The Pap test is one of the most reliable and effective cancer screening tests available. It also can find other conditions that might need treatment, such as infection or inflammation.

In addition to the Pap test—the main test for cervical cancer—the HPV test may be used for screening women aged 30 years and older, or women of any age who have unclear Pap test results.

If you are 30 or older, and your screening tests are normal, your chance of getting cervical cancer in the next few years is very low. For that reason, your doctor may tell you that you will not need another screening test for up to three years. But you should still go to the doctor regularly for a check-up that may include a pelvic exam. Learn more about extending the interval between screenings.

It also is important for you to continue getting a Pap test regularly—even if you think you are too old to have a child, or are not having sex anymore. If you are older than 65 and have had normal Pap test results for several years, or if you have had your cervix removed (during an operation called a hysterectomy), your doctor may tell you it is okay to stop getting regular Pap tests.

For more information, please read the U.S. Preventive Services Task Force overview of cervical cancer screening recommendations.

How to Prepare for Your Pap Test

If you are going to have a Pap test in the next two days, you should not

• Douche, which means rinsing the vagina with water or another fluid.
• Use a tampon.
• Have sex.
• Use a birth control foam, cream, or jelly.
• Use a medicine or cream in your vagina.

You should also schedule your Pap test for a time when you are not having your period.

Pap Test Results

It can take up to three weeks to receive your Pap test results. Most results are normal. But if your test shows that something might not be normal, your doctor will contact you and figure out how best to follow up. There are many reasons why your Pap test results might not be normal. It usually does not mean you have cancer.

If your Pap test results show cells that are not normal and may become cancer, your doctor will let you know if you need to be treated. In most cases, treatment prevents cervical cancer from developing. It is important to follow up with your doctor right away to learn more about your test results and receive any treatment that may be needed.

©2012 An Inconvenient Woman. All Rights Reserved.

Learn about cervical cancer screening and treatment before making a decision about the HPV-vaccine

Related Information: Cervical Cancer Screening

Almost all cervical cancers are caused by human papillomavirus (HPV), a common virus that can be passed from one person to another during sex. There are many types of HPV. Some HPV types can cause changes on a woman’s cervix that can lead to cervical cancer over time, while other types can cause genital warts.

HPV is so common that most people get it at some time in their lives, but HPV usually causes no symptoms so you can’t tell that you have it. For most women, HPV will go away on its own; however, if it does not, there is a chance that, over time, it may cause cervical cancer.

Two tests can help prevent cervical cancer:

• The Pap test (or Pap smear) looks for precancers, cell changes on the cervix that might become cervical cancer if they are not treated appropriately.
• The HPV test looks for the virus that can cause these cell changes.

The Pap test is recommended for all women. Talk with your doctor, nurse, or other health care professional about whether the HPV test is right for you. The most important thing you can do to avoid getting cervical cancer is to have regular screening tests.

More Steps to Help Prevent Cervical Cancer

These things may also help lower your risk for cervical cancer:

• Don’t smoke.
• Use condoms during sex.*
• Limit your number of sexual partners.

Risk Factors

In addition to HPV, other things can increase your risk of cervical cancer. They include:

• Not having regular Pap tests.
• Not following up with your doctor if you had a Pap test result that is not normal.
• Having HIV, the virus that causes AIDS, or another condition that weakens your immune system (making it hard for your body to fight off health problems).
• Smoking.

Signs and Symptoms

Early on, cervical cancer usually does not cause signs and symptoms. Advanced cervical cancer may cause bleeding or discharge from the vagina that is not normal for you, such as bleeding after sex. If you have any of these signs, talk to your doctor. They may be caused by something other than cancer, but the only way to know is to see your doctor.

Treatment

If your doctor says that you have cervical cancer, ask to be referred to a gynecologic oncologist—a doctor who has been trained to treat cancers of a woman’s reproductive system. This doctor will work with you to create a treatment plan.

*HPV infection can occur in both male and female genital areas that are covered or protected by a latex condom, as well as in areas that are not covered. While the effect of condoms in preventing HPV infection is unknown, condom use has been associated with a lower rate of cervical cancer.

Page last reviewed: December 22, 2008
Page last updated: December 22, 2008
Content source: Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion

©2012 An Inconvenient Woman. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.