Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.

In an online follow up to the CBS TV interviews, CBS News investigative journalist, Sharyl Attkisson, reports Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.

Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

Read Judicial Watch reports on Gardasil
Dr. LaPook’s Story on HPV
Attkisson’s Exclusive Report on Gardasil

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. “The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program.”

“The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s  Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade’s article, as they are based on a denominator of doses distributed from Merck’s warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade’s work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information,” said Harper.

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks – “small but real” – could occur more often than the cervical cancer itself would.

“Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade’s work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil.”

She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. “The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers – something never stated, but often inferred by many in the population– a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably.”

CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.

Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”

©2012 An Inconvenient Woman. All Rights Reserved.

• Yeast vaginitis is the second most common vaginal infection after bacterial vaginosis
• 75% of women experience an episode of vaginal yeast infection at some time in their life
• Yeast infections are caused by fungal organisms.
• The majority of vaginal yeast infections are caused by Candida Albicans
• There are some less common yeast organisms such as Torulopsis Glabrata that may cause infections that do not clear up with the usual therapies
• Yeast infections may be more common in women who have taken antibiotics, are on hormonal contraception, have diabetes and or are pregnant.
• Women who have medical conditions or take medicines which weaken the immune system are at greater risk for yeast

Signs and Symptoms of Yeast Vaginitis

• Yeast infections may cause no symptoms
• Sometimes yeast is noted on a Pap test and does not require treatment, unless there are symptoms
• There may be increased vaginal discharge with yeast infection
• This is typically described as thick or curdy
• There may be mild to moderate itching and irritation
• If the genital skin becomes very irritated, it may become red, swollen and may develop splits.

How is yeast diagnosed?

• The symptoms of thick curdy discharge, itch and irritation are classic for yeast
• Recent antibiotic use or steroids may suggest the possibility of yeast
• The health care provider will perform a vaginal exam and observe the genital skin
• The acid base level of the vagina is generally normal
• Samples of vaginal discharge may be taken with a swab
• The sample will be evaluated under the microscope for the presence of yeast
• Even when yeast is present, it is only seen under the microscope half the time
• Seeing yeast under the microscope confirms the diagnosis, but if yeast is not seen, the infection may be treated based on the symptoms. In some cases, a culture may be sent to the laboratory by swabbing the vagina and placing it in a culture tube.
• The culture is more accurate than the information that is obtained under the microscope and takes a few days to get the results
• A culture is used when a woman has a complicated problem such as failure to clear her infection or repeated infections.

Treatment of Yeast Vaginitis

• Over the counter medications can be obtained without a prescription
• These include creams for the external genital skin, suppositories and creams for the vagina that are inserted with an applicator
• Caution should be used when self-treating for yeast. Women who have been previously diagnosed for yeast and develop similar signs and symptoms may consider choosing to obtain over the counter treatments
• If a woman does not improve, she should seek the advice of a health care provider.
• Women who have frequent yeast infections may need to be treated for longer than the usual length of time
• If you have frequent yeast infections you may want to discuss longer treatment with your practitioner
• If you are pregnant, you should be sure to consult with a health care practitioner

Answers to Commonly Asked Questions

• Yeast is generally not sexually transmitted. It is not necessary to treat a male partner in most cases
• Yeast infections are common in pregnancy and may be treated with the advice of the health care practitioner
• Yeast infections are common in healthy women. If there is no other reason for concern, it is unlikely that HIV or Diabetes testing is indicated.

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.

An Abnormal Pap Test

What is a Pap Test?

A Pap test (sometimes called a Pap smear) checks for changes in the cervix that could, over time, become cancer. During your recent Pap test, cells were taken from the surface of your cervix and inside its opening. These cells were sent to a pathologist, a doctor who specializes in finding abnormalities of cervical cells. The pathologist examined your cells under a microscope and noted their size, shape, color, and contents. Your cervical cells were not entirely normal.

Is having an abnormal Pap test serious?

Hearing that you have an abnormal Pap test may make you worry that you might have cervical cancer. The good news is that you probably do not. Cervical cancer is a relatively rare condition. Most abnormal Pap results are not cancer. It may be comforting to know that abnormal Pap test results are not uncommon. About 1 in every 20 Pap test results are considered abnormal.

What is abnormal about my Pap test cells?

There are many reasons why a Pap test may be interpreted as abnormal, most of which are not serious. Some of the most common causes of abnormal Pap smears are described below.

Atypical (atypical squamous cells of undetermined significance (ASCUS) or atypical glandular cells of undetermined significance (AGUS)).

Atypical means that abnormalities were found in your cells. Pathologists are uncertain what these cells actually represent. So a woman with these results needs to have follow-up. Your clinician will determine which type of follow-up is best for you. Some women need a repeat Pap testing 6 months. Others may have an HPV test. In most cases, women will not be found to have a serious problem following further evaluation. However, a few women will actually have significant cervical disease that should be treated.

Dysplasia means that cells from an abnormal precancerous growth were found on the Pap smear.

Dysplasia describes the cells that are no longer normal but are not yet cancer.
There are many stages in the process of a normal cell becoming cancer. Dysplasia is call mild (low-grade squamous intraepithelial lesion or LGSIL) and moderate to severe (high-grade squamous intraepithelial lesion or HGSIL) depending on how abnormal the cells have become and the extent of tissue affected. In a small number of women, dysplasia may eventually develop into cancer, if not treated.

Cancer or carcinoma of the cervix may be detected by a Pap smear. In addition, Pap smears can also recognize cancer cells from other sites in the body (such as the uterus) that may have moved to the cervix.

How did this happen?

It is often hard to know what exactly caused you to have an abnormal Pap smear.
Because there are many types of abnormal Pap smears, the reason for abnormal changes on your cervix varies. The changes may result from a sexually transmitted infection (including human papilloma virus), lack of a hormone, intravaginal medication, contraceptives, irritation or a cancer-associated growth.

How long have the abnormal cells been on my cervix?

It is difficult to know how long the abnormal cells have been on your cervix. Abnormal cells caused by an infection may have been present for a just a brief time. In contrast, abnormal cells caused by dysplasia may have been present for much longer. Normal cells change very slowly to become precancerous cells, and it takes many years for precancerous cells to become cancer. Most abnormal cells never change into cancer.

Does an abnormal Pap smear mean that I won’t be able to have children?

An abnormal Pap smear can be caused by lots of different things, most of which have no effect on your fertility or ability to have children. It is extremely unlikely that your abnormal Pap smear or treatment for an abnormal Pap smear will prevent you from having children, unless it was reported as invasive cancer.

Does this mean that I could pass something to my partner?

Most causes of an abnormal Pap smear are not things that you could pass to your partner.
If your Pap smear report indicates that you may have a sexually transmitted infection,you could pass this infection to your partner. Many of these infections can be successfully treated with antibiotics or other medications.

How can I make sure my next Pap smear will be of good quality?

There are a few things that you can do to ensure that your next Pap smear is of good quality. Don’t use vaginal medications, douches, or tampons 2-3 days before your Pap smear. Also, avoid having sexual intercourse for 24 hours before your appointment. Don’t schedule your appointment during your period. Menstrual blood and vaginal medicines can make it difficult to see your cervical cells clearly.

What should I do now?

If your report found inflammation or infection, you may need to return to the clinic to be examined so that your healthcare provider can determine what is causing your abnormality. Sometimes you can be treated without another examination based on the abnormal Pap smear report.

If your Pap smear report indicated atypical cells, you may need a repeat Pap smear, a test for human papillomavirus or you may need an examination by colposcopy. Your healthcare provider will let you know what type of additional test may be best for you. If you are a postmenopausal woman not taking estrogen replacement treatment, you may be asked to take estrogen and return for another Pap smear in one month.

If dysplasia or a squamous intraepithelial lesion was found, the next step may involve taking a closer look at the cervix using a colposcope. A colposcope is like a microscope positioned outside the vagina that magnifies the cervix. A vinegar solution is applied to the cervix which turns abnormal tissue white. A white region contrasts with the rest of your cervix which is pink. By using a colposcope, we can find out the source of the abnormal cells that were seen on your Pap smear by taking a biopsy (a tiny sample of tissue). If your tests show only a mild abnormality, your health care provider may recommend close follow-up with Pap smears in within 6 months because often your body overcome mildly abnormal cells. For more severe abnormal cells, treatment to destroy the abnormal area is recommended. In the rare event that your Pap smear reported carcinoma, your health care provider will discuss further evaluation and treatment options with you.

Can I be cured?

Keep in mind that there may actually be nothing wrong with your cervix. Some infections can be treated with medication. If precancerous cells or cancer are on your cervix, there are a variety of treatments available to remove the abnormal cells, including freezing, burning, laser treatment, or surgical removal. If invasive cancer is found, more intensive therapy is needed.

What can I do to prevent having cervical cancer or precancerous changes in the future?

You can increase your chances of not having cervical cancer or precancerous changes in the future by protecting yourself against sexually transmitted infections, not smoking tobacco products, and by getting routine Pap smears.

A Pap smear is only useful in detecting and preventing cervical cancer or precancerous changes if you return for follow-up evaluation and treatment appointments, when necessary. Keep in mind that it is very likely that the cause of your abnormal Pap smear can be easily treated, if treatment is necessary. In addition, the earlier abnormalities are treated, the easier they are to treat.

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.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Each year 13,000 women are diagnosed with cervical cancer in the United States. In most cases cervical cancer can be prevented through early detection and treatment of abnormal cell changes that occur in the cervix years before cervical cancer develops. We now know that these cell changes are caused by human papillomavirus, commonly known as HPV.

The traditional test for early detection has been the Pap test. Now a test for HPV is being offered that can be used with the Pap test in women starting at 30 years of age and in women of any age when the Pap test alone has found slightly abnormal cell changes.

What is the Pap Test?!

The Pap test finds changes in the cells of the cervix (the mouth of the womb) that are not normal. The test involves taking a small sample of cells from the cervix, usually during a routine pelvic exam. The cells are sent to a laboratory where they are prepared and evaluated under a microscope.

What is the HPV test?

The HPV test can find any of the 13 types of HPV that are most commonly found in cervical cancer. The presence of any of these HPV types in a woman for many years can lead to cell changes that may need to be treated so that cervical cancer does not occur.

The HPV test is done at the same time as the Pap test by using a small soft brush to collect cervical cells that are sent to the laboratory, or the HPV testing sample may be taken directly from the Pap sample.!

What is HPV?

HPV is a virus that is very common. In fact, most men and women are infected with HPV at some time in their lives. There are approximately 100 types of HPV. Some HPV typesonly infect the genital area and may cause warts, some cause mild changes in cervical cells that do not turn into cancer, and some cause changes that may become cervical cancer if present for many years. The types of HPV that are found in the genital areas are usually passed on during sexual contact (sexually transmitted). HPV types that cause warts on the hands or feet do not cause genital warts or cervical cell changes, nor do genital HPV types generally spread outside the genital area.

How common is HPV?!

HPV is the most common sexually transmitted virus. The likelihood of getting an HPV infection sometime in a person’s life has been estimated to be 75% or more.! This means that anyone who has ever had sexual relations has a high chance of being exposed to this virus, but only a small number of women infected with HPV develop cell changes that need to be treated. In almost all cases, the immune system will keep the virus (including the cancer-related HPV types) under control or get rid of it completely. However, if HPV infection does not go away over many years, there is a greater chance of developing cell changes that may lead to cervical cancer. Only very rarely does the presence of HPV lead to cervical cancer.

Can HPV infections be treated?

There is currently no treatment available for the virus itself. However, good treatments do exist for the problems HPV can cause, such as cervical cell changes or genital warts. Your healthcare provider will discuss these treatment options with you, if you need them.

SHOULD I HAVE AN HPV TEST?

I am 30 or older — Should I get the HPV test in addition to my Pap test?

In women 30 and over, screening using both an HPV test and a Pap test is more likely to find abnormal cervical cell changes than either test alone. If both tests are negative (normal), a woman may safely have her next Pap and HPV test in three years depending on her past Pap test findings and other risk factors. For this reason, some women now may have an HPV test when they have their Pap test. It will still be important to continue having routine recommended preventative health exams.

I am under age 30 – Should I get the HPV test in addition to my Pap test?

No. HPV is very common in women under the age of 30 and cervical cancer is very rare in this age group. Most women under 30 with HPV will get rid of the virus without treatment. So including an HPV test along with your Pap isn’t helpful for younger women and might be harmful if it resulted in too many tests and unnecessary treatment. After age 30, HPV is much less common. If you are over the age of 30 and you test positive for HPV it is more likely that you may have gotten it many years before and your immune system hasn’t gotten rid of it. Because HPV must be present for many years to cause cell changes, testing for HPV after the age of 30 is much more helpful.

I am under 30 but my doctor suggested HPV testing after my Pap came back as ASC-US.

Why?

The most common abnormal Pap is called ASC-US, or atypical squamous cells. About half of the women with ASC-US have these cell changes because of the presence of HPV, while the other half do not. If you have a follow-up HPV test after an ASC-US Pap and the HPV test is negative, you probably need no additional follow-up other than to repeat your Pap in one year. Usually only women with ASC-US testing positive for HPV need further evaluation. HPV testing is helpful at any age for determining which women with ASC-US need follow-up. This is different from using the HPV test with the Pap as part of your normal health visit.

WHAT IF MY RESULTS ARE…

What if the HPV test and Pap test are both normal?

If both the HPV test and the Pap test are normal you have very little risk of any
worrisome changes occurring in your cervix over the next 3 years. You should discuss with your physician the optimal time for follow-up testing according to professional recommendations and the physician’s assessment of your clinical history.

If I tested positive for HPV, what does this mean for me?

Most HPV infections go away without treatment because the immune system finds the virus and either gets rid of it or suppresses it to the point that it never returns to cause problems. Cell changes that may eventually lead to cervical cancer only occur when this does not happen and HPV stays for many years. Even though HPV is found in cervical cancer, most people testing positive for HPV are not at risk for getting cervical cancer because they have the virus for only a short time (months rather than many years).

Therefore, women with a normal Pap who test positive for HPV will usually be tested for HPV again in 6-12 months. Testing positive a second time does not mean that there is great risk of cervical cancer, or even of cell changes that may lead to cervical cancer, but it does mean that further evaluation will likely be recommended.

If I test positive for HPV, how did I get it?

HPV is usually acquired by direct skin-to-skin contact during intimate sexual contact with someone who is infected. Most men and women are not aware that they have the virus. Condoms do not offer complete protection from HPV. Increasing numbers of partners increases the risk of getting HPV, but the virus is so common that having only a single lifetime partner does not assure protection. It is usually impossible to determine when, and from whom, HPV was caught. HPV may be detected fairly soon after exposure, or may not be found until many years later. For all these reasons, it is not helpful, nor fair to blame your partner.

What does my positive HPV test mean for my partner?

Most sexually active couples share the HPV until the immune response eliminates the infection. Partners who are sexually intimate only with each other do not pass the same virus back and forth. In other words, when the virus is shared, being exposed to more of the same virus by one’s partner does not make it more difficult to eliminate the infection. When HPV infection goes away the immune system will remember that HPV type and keep a new infection of the same HPV type from ever occurring again. However, because there are many different types of HPV, becoming immune to one HPV type may not protect you from getting HPV again if exposed to another HPV type.

If I have HPV or a cell abnormality, is there anything I can do?

Don’t smoke. Smoking has been shown to increase the chance that cell abnormalities might progress to more severe changes. Be sure to keep your follow-up doctor appointments.

Will I have the HPV virus forever?

Probably not. HPV infection is very common, but it usually goes away within 1-2 years.

I am shocked to have a virus that is usually sexually transmitted! How should I respond?

Just remember that almost everyone gets HPV at some time. HPV is not likely to change your life. If you have tested positive for HPV there may be a short period of time during which follow-up may seem to be a bother, but little more. Cervical cancer, the most serious problem associated with HPV, is rare and almost always prevented through regular testing for cervical cell changes that could lead to cancer.

Key Points to Remember:

• Cervical cancer is preventable. Early detection of abnormal cell
• changes is important.
• Almost all women will have HPV at some point, but very few will develop cervical cancer. The immune system of most women will usually suppress or eliminate HPV. Only HPV infection that does not go away over many years can lead to cervical cancer.
• It can be helpful to know your HPV status. This can help determine how often your clinician will recommend that you be tested.
• Don’t blame. Your HPV status is not a reliable indicator of your sexual behavior nor that of your partner.

Resources on HPV and Cervical Cancer

National HPV & Cervical Cancer Resource Center
www.ashastd.org
Women’s Cancer Network
www.wcn.org
American Cancer Society
www.cancer.org
1-800-ACS-2345
The American Society for Colposcopy and Cervical Pathology
www.asccp.org
National Cervical Cancer Coalition
www.nccc-online.org
National HPV & Cervical Cancer Public Education Campaign
www.cervicalcancercampaign.org
National Women’s Health Resource Center
www.healthywomen.org
The HPV Test
www.thehpvtest.com
Eyes on the Prize: Support and Information for Gynecologic Cancers
www.EyesOnThePrize.org
The Centers for Disease Control (CDC)
www.CDC.gov

Copyright © 2003, 2008 ASCCP. All Rights Reserved.
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©2012 An Inconvenient Woman. All Rights Reserved.

Merck’s HPV vaccine, Gardasil, was approved by the FDA and endorsed by the Center for Disease Control (CDC)  in June of 2006. According to the Merck marketing literature, the $360, three shot-series of Gardasil, administered over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases and also prevents two other strains linked to 90 percent of genital warts cases. The nationwide rollout of Gardasil  was accompanied by an award-winning marketing blitzkrieg that helped raise the profile of HPV through a large-scale communications campaign, highlighted by the “Tell Someone” TV adds shown on channels with high-teen viewer-ship. Additionally, Merck waged an extensive lobbying campaign in State-houses, Congress, city councils and regulatory agencies.  Merck & Company carpet bombed the halls of power with cash, goods, services and favors to be named later. The ‘Charm and Cash Offensive’ yielded early victories amongst Federal regulators and ‘soft target’ states.

By early 2007, Wall Street analysts predicted Gardasil would generate $2 billion to $4 billion that year even without the sought-after State mandates. The State mandates offered legal cover and protected Merck shareholders from future vaccine liability losses. Based on projected Gardasil sales, the 2006 Merck Annual Report promised shareholders excellent market share and increased dividends. Good news indeed, for shareholders battered by the losses Merck endured after it pulled Vioxx off the market in 2004 (Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis and acute pain that was used by 2 million people, was linked to increased risk of heart attack and stroke.)

Things were finally“looking’ good in the Merck neighborhood”…until the public  started to question why politicians were moving so quickly to Mandate the very expensive, newly released, HPV vaccine for school girls.

Critics pointed out that this vaccine is not to prevent childhood disease like mumps, measles or chicken pox…contagious  diseases that can move through schools quickly, effecting large numbers of children. Gardasil is a vaccine for a  sexually transmitted virus, that if left undetected by regular PAP screening, could lead to cervical cancer in a woman’s later years. Gardasil ‘protects’ girls from cervical cancer, the most easily detected and treatable of all the cancers that affect women.

Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer, and is credited with a 74 percent drop in cervical cancer deaths since 1955.

The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain.

Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine.( Note: When Merck is making it’s pitch for the need for Gardasil, they always quote the World HPV infection rates and Cervical cancer deaths, not the cervical cancer numbers for the United States.)

“The vaccine is not nearly as effective as vaccines for mumps or measles, but it is an important step forward in public health,” said Dr. John Swartzberg, director of public health policy at the University of California at Berkeley. “The vaccine will decrease the two most common strains of HPV that cause cancer, and we’ll be left with strains that have far less potential to cause cancer. In this case, the benefits outweigh the risks.”

That sounds like a great justification for childhood inoculation
until you start thinking about everything we just don’t know yet…

As with any new drug, there are potential risks that short-term studies used for federal approval don’t detect. Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV.

“My concern is that we are pushing ourselves into something worse than we already have,” Dr. Young said. “Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains.”

Gardasil is effective against two of 10 carcinogenic HPV strains. In the United States, those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women.

In answer to the issue of Gardasil possibly producing  more aggressive HPV strains, Dr. Haupt, executive director of medical affairs in Merck’s vaccine division, has said, “The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute.” Despite Merck’s doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease. “It is an important issue to us,” Dr. Haupt said. “But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won’t over time.”

What about Merck’s early lobbying push for State mandated Gardasil shots for school girls?

State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group.

Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness  — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years — meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.

“It is a delicate balancing act,” said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. “If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won’t work”

Lets Look At The Numbers

In July of 2007, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, endorsed the Gardasil inoculation for girls 11 to 12 and Merck lobbyists persuaded  lawmakers and regulators to start the fast-track push for  mandatory HPV vaccination legislation.

Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer. “It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer,” said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use.

Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the current and proposed legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S.

American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 — still outside Gardasil’s five-year protection window if given to sixth-graders.

Merck is working on a booster shot to extend Gardasil’s five years of protection. “We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil,” Dr. Haupt said.

Vaccine boosters vary in longevity. A ‘hepatitis B’ booster is required every 10 years, while others can provide lifelong immunity. None of the current or proposed HPV vaccine legislation addresses the potential for booster inoculations that could fall outside the enforcement mechanism — rules that bar students from school unless they have the required shots.

According to the CDC, seventy percent of females are sexually active by age 18. “The point in vaccinating kids 9 to 12 is not to reduce number of cases found in that age group, but to vaccinate prior to beginning sexual activity,” said CDC spokesman Curtis Allen. “The benefits of the vaccine decrease as women age because they are more likely to have already been infected by one of the HPV strains.”

But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers — who have billed the inoculations as a cure to cervical cancer — would have a much greater effect on cervical cancer rates by mandating its use later. Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18.

In April 2006,  Lancet, a British medical journal published a study that concluded the GlaxoSmithKline HPV vaccine, Cervarix, is effective for 4½ years. Cervarix is not yet licensed for use in the United States, but is in wide use throughout Europe. So the targeted age group is a problematic for the EU legislators proposing mandatory HPV vaccination polices as well.

What is the probability of a school girl in America contracting cervical cancer later in her life?

Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV.

“However, only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer,” Dr. Saraiya said.

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

But the fact that very few U.S. women are affected by cervical cancer, hasn’t stopped the rush by lawmakers to push mandatory HPV vaccines for school girls.

“The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it,” said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health.

According to Merck’s clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer.

Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Dr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer.

Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck’s labeling documents for Gardasil.

“The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer,” Dr. Young said. “It has not been studied long enough to know that it prevents cervical cancer.”

Will Gardasil be a Mandated Vaccine For ALL American School Girls?

Well before FDA regulators approved the HPV vaccine, Gardasil,  in mid-2006, Merck’s lobbyists had started “Education Programs” aimed at State Representatives, Governors, and special interest groups to instigate a rapid deployment plan to mandate the Gardasil vaccine  for school girls around the country. In early 2007,  reacting to a furor from some parents, advocacy groups, public health experts, and after several public relation disasters precipitated by inept politicians like Texas Governor Rick Perry, ‘ham-handed’ Executive Order mandating the Gadasil shot for every school girl in Texas, Merck said that it would stop lobbying state legislatures to require the use of its new cervical cancer vaccine. The speed with which legislatures and other Government officials moved to require use of the vaccine before school entry has galvanized critics. Some say making a vaccine mandatory would pre-empt parental choice; others contend that protection from a sexually transmitted virus would encourage promiscuity. These voices were joined by others worried about the influence of pharmaceutical companies over our “Representative” Government. Many of the legislators who have sponsored some of the state laws to make the vaccine mandatory, are members of  Women in Government. WIG is a non-profit organization that is heavily subsidized  by Merck.

Merck representatives are quoted as publicly stating the company would stop lobbying specifically for state mandates, many of which would require girls to be vaccinated before they entered sixth grade. Merck made the decision to stop lobbying legislators  after realizing that their campaign had fueled objections across the country that could undermine adoption of the vaccine.

Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division, said the company had acted after hearing from public health officials and medical organizations that its campaign was counterproductive. “They believe the timing for the school requirements is not right,” Dr. Haupt said, adding: ”Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and Merck’s involvement in that are being viewed as a distraction to that goal.”

But Dr. Haupt said that Merck would continue to provide health officials and legislators with education about the vaccine and would continue to lobby for more financing for vaccines in general. Public Interest groups continue in their attempts to track the  money and staff resources Merck had expended in its efforts to require use of the cervical cancer vaccine.

Dr. Larry K. Pickering, executive secretary of the Advisory Committee on Immunization Practices, the federal panel that originally recommended the vaccine’s use, applauded Merck’s decision to stop lobbying. ”They finally are going to stop doing that, which all of us will be happy about,” he said. Dr. Pickering, who works at the Centers for Disease Control and Prevention, said that while the vaccine was useful, more data on its safety, effectiveness and cost was needed. Objections to the vaccine could undermine its use. ”I think it has been somewhat counterproductive. Anything that takes away from the process of getting vaccine into people is deleterious to the whole process.”

Merck Put A Noble Spin to Getting Caught Handing Out Cash For Legislative Favors

“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer — the second-leading cancer among women around the world — and other HPV-related diseases for as many people as possible, and as quickly as possible,” Merck’s Dr. Haupt said about its lobbying efforts.

If you are concerned about the possibility of legistlation concerning mandatory HPV vaccines for school girls keep your eye on your representatives.

The current Merck position on lobbying is all about “For Now”.
Merck has only been delayed, not deterred.

©2012 An Inconvenient Woman. All Rights Reserved.

In late August 2007, Cathy Gulli produced an article for the Canadian Magazine, MACLEANS. The article was called,  “Our girls are not guinea pigs” and posed a critical question to her readers, “Is an upcoming mass inoculation of a generation unnecessary and potentially dangerous?”

Gulli’s article noted that in almost every instance when adverse effects have been reported in both the US and Australia, the response of medical authorities and government officials is the same: bad reactions are rare. When they do occur, there’s no evidence that Gardasil was the cause.  Critics of the fast track deployment of the HPV-vaccine say the real issue is that no one really knows, medically speaking, just how dangerous this vaccine could be. Abby Lippman, an epidemiologist at McGill University aired her concerns about the speed with which Gardasil has been adopted in the Canadian Medical Association Journal. “We’re making guesses that it’s going to last long, that [we're immunizing] the right age [of girls], and that it’s effective. We don’t have a solid basis for this thought.”

I reviewed Gulli’s article a few weeks ago when researching an HPV-vaccine paper for colleagues in the EU, Canada and Australia.  Sadly, seventeen months later. the issues raised in the article still stand unresolved:

Concerns that not enough 9 to 15-year-old girls were studied during clinical trials for Gardasil;
“Approximately 1,200 were enrolled, and according to a June report by the Canadian Women’s Health Network, only 100 of them were age nine, and that limited group was only followed for 18 months. “Clearly, this is a very weak information base on which to construct a policy of mass vaccinations for all girls aged nine to 13, as per the National Advisory Committee on Immunization’s recommendations,” the CWHN report summarized.”
Questions as to long term effectiveness of Gardasil;
“Given the longest that clinical trial participants who received the vaccine were tracked was for five years. “If we’re talking about vaccinating nine-year-old girls we want protection for 20 or 30 years,” concedes Laura Koutsky, an epidemiologist at the University of Washington who helped Merck design the clinical trials and oversaw them for Gardasil. “Can we infer protection out to that period? We don’t know. But we have evidence that suggests it’s likely.”

The list of issues Gulli’s raised those many months ago is still pertinent today. The advocates of the Gardasil solution still refer to critics as medical Luddites. That does not alter the fact that we Luddites are still waiting for answers to questions posed over two years ago. We are still asking, “Why have governmental entities but HPV-vaccine on a hurry-up deployment track?”

According to the Canadian Women’s Health Network, most women who don’t smoke, eat well and have a healthy immune system will clear the virus without any treatment. And the Public Health Agency of Canada has said that more than 80 per cent of HPV infections acquired at an early age were gone within a year and a half. Even better, after a woman has fought off a strain, she has almost no chance of contracting it again.

I have included a copy of Cathy Gilli’s article below.  The issued raised are still germane to the Gardasil discussion today.

Our girls are not guinea pigs

The morning after Emily Cunningham got a shot of Gardasil, the new vaccine that protects against four strains of the human papilloma virus(HPV)that can cause cervical cancer and genital warts, she woke up with a headache, and neck and back pain. By 9 p.m. that evening in April, she had a fever so high “you could feel the heat rising from her a foot away,” according to her mother, Laurie. She was delirious during the night, and the following day couldn’t walk without assistance. Bedridden for nearly a week, the 18-year-old from Wyoming missed school, and took Tylenol every four hours. “If Emily had been the only one to get sick we would have said she must have had something else [like the flu],” explained Laurie, “but we know of three other students to have reactions, that is why we are concerned.”

Emily’s story is only one of 1,637 complaints involving Gardasil, filed as of May to the Vaccine Adverse Event Reporting System(VAERS), a national surveillance database sponsored by the Food and Drug Administration(FDA)and the Centers for Disease Control and Prevention(CDC)in the United States. One could discount what happened to Emily because she had a flu shot that same day, but other really bad reactions have been reported, including seizures, paralysis — and worst of all, three deaths, including one girl who “died of a blood clot three hours after getting the Gardasil vaccine,” reads one complaint. Elsewhere in the world there have been reports of similar reactions. In Melbourne, Australia, where a national HPV vaccination program started in April, 26 girls reportedly fainted and were mildly paralyzed after getting one shot each.

In almost every instance, the response of medical authorities and government officials is the same: bad reactions are rare. When they do occur, there’s no evidence that Gardasil was the cause. Arguably, both points could be true. Some say the problem, however, is that no one really knows, medically speaking, just how dangerous this vaccine could be. “Usually at this stage in the life span of a vaccine we would not have this kind of action,” Maclean’s has heard from Abby Lippman, an epidemiologist at McGill University who recently aired her concerns about the speed with which Gardasil has been adopted in the Canadian Medical Association Journal. “We’re making guesses that it’s going to last long, that [we're immunizing] the right age [of girls], and that it’s effective. We don’t have a solid basis for this thought.”

And yet, nearly every province in Canada has, in recent weeks, put forth some plan to implement an HPV vaccination program that will see the mass inoculation of an entire generation of girls — some as soon as this September — with no serious acknowledgement of the potential health risks they might face. While everyone debates the moral and political consequences of endorsing Gardasil, the fundamental, essential medical and scientific debate remains untouched. So, in a few weeks, when thousands of girls concerned about Facebook and who will be in their class this year — not HPV — go back to school, many will become part of the biggest Canadian science experiment in decades. They will be the guinea pigs.

To find out the worst case scenario when it comes to Gardasil, one need only hear the stories of parents whose children have become ill or died after receiving the vaccine. Recently, one angry father from Chicago phoned up John Driscoll, an attorney at the law firm Brown & Crouppen in St. Louis, Mo. Shortly after receiving Gardasil, his daughter was diagnosed with Guillain-Barré syndrome, an autoimmune disease. It starts with tingling sensations in the legs, which then travel to the upper body, and finally become so intense in the muscles they paralyze, though often they diminish over time. “He believes it was linked,” says Driscoll, and wants to sue Merck & Co., Inc., the U.S. pharmaceutical company that manufactures Gardasil. This will be the first such lawsuit, but Driscoll, who believes the vaccine was rushed to market, predicts that, “unfortunately, we’ll get more and more calls about this in the future.”

In fact, Guillain-Barré syndrome is one of the more serious adverse reactions noted in the hundreds of complaints filed to VAERS. “When you go to your doctor’s office, the list of symptoms is very short: dizziness, fainting. But there’s a whole laundry list of potentially serious side effects,” says Dee Grothe, an investigator at the Washington-based watchdog organization Judicial Watch, which filed freedom of information requests to access details about negative reactions relating to Gardasil. “This is information that everybody receiving the shot should know,” she says.

Merck Frosst Canada Ltd., which is the Canadian manufacturer of the vaccine, sees no proof that Gardasil is responsible for the illnesses or deaths. “There is a relationship between Gardasil and these events, but there’s no cause and effect,” says Sheila Murphy, manager of public affairs for Merck Frosst. Similarly, the FDA and CDC have said there’s no likely connection(they claim the two deaths from blood clots were caused by birth control pills taken at the time of immunization, and the third death was due to heart inflammation brought on by the flu). But some skeptics find these explanations ambiguous and suspicious. “I’m not a doctor, but when I read this information, to me, that is a clear indication that there may have been a problem,” says Grothe.

It’s obvious that even in the best-case scenario, many believe there is still not enough known about the HPV vaccine to warrant mass inoculation programs. For starters, there are concerns that not enough nine- to 15-year-old girls were studied during clinical trials for Gardasil. Approximately 1,200 were enrolled, and according to a June report by the Canadian Women’s Health Network, only 100 of them were age nine, and that limited group was only followed for 18 months. “Clearly, this is a very weak information base on which to construct a policy of mass vaccinations for all girls aged nine to 13, as per the National Advisory Committee on Immunization’s recommendations,” the CWHN report summarized.

The CWHN also worries about the long-term effectiveness of Gardasil, given the longest that clinical trial participants who received the vaccine were tracked was for five years. “If we’re talking about vaccinating nine-year-old girls we want protection for 20 or 30 years,” concedes Laura Koutsky, an epidemiologist at the University of Washington who helped Merck design the clinical trials and oversaw them for Gardasil. “Can we infer protection out to that period? We don’t know. But we have evidence that suggests it’s likely.”

Inference, though, is not the scientific evidence some expect. Analysis beyond clinical trials is critical to ensuring public safety, warns Lippman. “What happens in the real world can be very different from what happens in the clinical research world,” where girls are in a controlled environment, and get health examinations frequently to gauge any problems. “The real world is where we find out what really happens when you let a vaccine loose on a population.”

A study in the May issue of the New England Journal of Medicine speaks to how real world situations such as “imperfect compliance”(such as not receiving all three doses of Gardasil), and a girl’s previous exposure to HPV, could take Gardasil’s 70 per cent protection against precancerous lesions(which lead to cervical cancer)down to a staggering 17 per cent. “That’s one more reason we should be slowing down,” says Hans Krueger, a health care consultant who has advised the B.C. Cancer Agency, among other organizations, on Gardasil. “This suggests to me we just don’t know enough.”

What’s more, there is some debate over just how many shots girls aged nine to 13 actually need — either the recommended three doses, or just two — which would cut costs(a triple shot costs $404). A collaborative research project, which will involve about 800 girls, to look into this is getting under way next week in B.C., Quebec and Nova Scotia. The latter province, for now at least, is going ahead with its three-dose plan for Grade 7 girls this September.

Nova Scotia is not the only province to put forth plans for mass immunization in recent weeks. Ontario announced it will give Gardasil to Grade 8 girls beginning in September. Newfoundland will administer the shot to Grade 6 girls, as will Prince Edward Island. Meanwhile, British Columbia and Quebec are expected to launch their programs at some point next year.

All this comes just as Merck’s competitor GlaxoSmithKline(GSK)is seeking Health Canada’s approval to market another HPV vaccine called Cervarix(already available in Australia, and heading towards approval in Europe). GSK claims that Cervarix’s edge is an adjuvant that, it claims, creates a stronger and longer-lasting immune response compared to the conventional aluminum-based adjuvants. And while Gardasil focuses on two strains(16 and 18)that account for 70 per cent of cervical cancer cases and two others that cause genital warts, Cervarix protects against four HPV strains responsible for 80 per cent of cervical cancers(types 16, 18, 31 and 45).

Canada’s widespread adoption of the HPV vaccine in some ways makes the country a guinea pig for Gardasil on an international scale, says Diane M. Harper, a lead researcher in the development of the HPV vaccine, and a professor at Dartmouth Medical School in New Hampshire who has worked with Merck and GSK. While developing nations where cervical cancer rates are high could stand to benefit the most from Gardasil, they aren’t “going to readily adopt a vaccine unless they feel comfortable that other countries have adopted the vaccine and done well and seen success with it. That’s the history of how the world has gone in health care.”

Merck has explicitly stated that Gardasil does not offer total protection against cervical cancer. And so the question remains, in the absence of HPV 16 and 18, what’s to stop other resistant strains of the virus from evolving into something more aggressive? “We’re making educated guesses of what we think will happen to the virus in the future based on what we know of the virus right now,” says Koutsky. A super-strain of HPV is unlikely to occur, she continues, because the papilloma genome does not evolve at a rapid pace. “But it’s true we don’t know,” she says.

One possibility is that other strains, which cause the remaining 30 per cent of cervical cancers, may become more prevalent. “If you knock off two big tough drug dealers who control 70 per cent of the market and take them to jail, the other guys will quickly fill the void,” says Andrew Lynk, a Sydney, N.S.-based pediatrician. “We’ve seen that also in the vaccination world.”

In the June report published by the Canadian Women’s Health Network, medical experts point to a cautionary tale in Alaska, where native children were inoculated en masse against a strain of pneumococcal pneumonia. A follow-up study found that, since the vaccinations in 2004, “the invasive pneumococcal disease rate caused by non-vaccine serotypes [had] increased 140 per cent compared with the pre-vaccine period.” Studies like this one, the CWHN warns, demand that the medical community, the government and the public consider “how Gardasil, or any other HPV vaccine, might alter the natural history of HPV infections — and whether other HPV strains might move in to occupy the vacated niche — before engaging in a massive vaccination program.”

Knowing about the potential dangers of Gardasil, one wonders if the recommendation for mass inoculation in so many provinces is even necessary. The HPV vaccine has been sold by Merck and its proponents as a tool for ending cervical cancer. But a quick look at statistics shows that the risk of developing this disease, let alone dying from it, is very low — in Canada, 1,350 women were diagnosed and 390 died last year, making cervical cancer the 11th-most common cancer in women here, and the 13th-most common cause of cancer-related death.

In fact, Canada has among the lowest incidences of cervical cancer in the world. But hype around Gardasil has created a false sense of urgency about the need for the vaccine, according to cautious observers such as Lippman. “If there was an epidemic and people were dropping dead on the street corner, you’d want to do something,” she says. But “we have the luxury to reflect, think and act wisely. Then we can put our foot into the street and cross. [Right now] I’m the yellow light mode.”

When HPV strains, of which there are up to 200, do cause infections, they are usually slow to grow, which makes identifying them through Pap smears relatively easy. In a statement published in the February issue of the Canada Communicable Disease Report, the National Advisory Committee on Immunization explained that “In general … the vast majority of precancerous lesions, which progress slowly, can easily be detected and treated.” Even when the HPV infection is caused by one of the cervical-cancer-causing strains, reports the Canadian Women’s Health Network, it takes about a decade for the disease to develop — long enough for women to get their Pap test done(annually, and then every three years after smears come back clear twice in a row).

Despite these promising outcomes, cervical cancer is being turned into a new millennium polio, according to Dr. Sharon Moalem, author of Survival of the Sickest, and a neurogeneticist and evolutionary biologist at New York’s Mount Sinai School of Medicine. “The problem that I’ve seen is many of the advocates for [Gardasil] say everyone should be vaccinated, but this is not polio and a lot of people can have HPV and not every variant of HPV causes cancer as far as we know.”

In fact, most people will wind up with HPV at some point in their lives and fight it off without ever even knowing they were exposed to the virus, which is primarily transmitted through skin contact with genitalia. According to the Canadian Women’s Health Network, most women who don’t smoke, eat well and have a healthy immune system will clear the virus without any treatment. And the Public Health Agency of Canada has said that more than 80 per cent of HPV infections acquired at an early age were gone within a year and a half. Even better, after a woman has fought off a strain, she has almost no chance of contracting it again.

HPV is so common that even infants and children have been found with infections, suggesting that the virus isn’t just transmitted sexually, says Krueger. While there is no conclusive literature explaining how else it might be contracted, some have suggested that newborns could acquire HPV while in their mother’s vaginal tract. However it happens, Gardasil critics point to these puzzling cases as another reason why the vaccine — which is only preventive, and won’t have any effect on those who already have HPV — shouldn’t be given to all girls. “These data do warn against assuming too quickly the lack of exposure to HPV in even young girls in developing vaccination programs and policies,” states the CWHN.

Even for the limited number of women who do wind up contracting the HPV strains that could lead to cervical cancer, some say current screening methods — Pap smears — are effective and safe ways of preventing the disease. About 79 per cent of Canadian women between the ages of 18 and 69 have had a Pap in the last three years, and according to the the immunization advisory committee, this has “led to dramatic reductions in invasive cancer in the developed world.”

Further proof of the test’s effectiveness is found in the fact that the majority of women who do wind up with cervical cancer — 60 per cent — were either unscreened or underscreened, meaning they didn’t get their Pap at all, or didn’t get it on schedule, according to the advisory committee. As such, the current push for young girls to be immunized largely ignores the group of women most affected: immigrants, refugees, Aboriginals, the disabled, poor and those living in remote regions(the rate of infection among Inuit women in Nunavut is 86 per cent). Realizing this, some have called on the federal government to reallocate the $300 million it put up for HPV vaccination programs in March toward targeting high-risk populations. “Maybe the money would be better spent hiring nurses who would set up mobile clinics and go out to the First Nations or immigrant neighbourhoods,” says Nova Scotia pediatrician Lynk.

Even if HPV vaccination programs continue to expand, the public needs to understand that young women can still develop HPV infection and cervical cancer after being immunized, say experts. Paps will be a critical complement to Gardasil, insists the immunization advisory committee. “Women who have been vaccinated will still be susceptible to other [high-risk] HPV types. Even if those types are less prevalent than HPV 16 or 18, these women should still expect to take part in the currently recommended cervical cancer screening programs.”

Harper, the HPV researcher at Dartmouth, tells of a yet unpublished study showing that, even if every female aged 12 to 26 is vaccinated, if they don’t go for Pap tests thereafter the rate of cervical cancer will actually go up compared to pre-immunization rates. “So there is significant danger in people feeling this vaccine offers them a force field protection,” says Harper, “and that could actually rebound back to us because there are other HPV types out there and they’re not going to stop causing cancer just because we’ve given a vaccine.”

All these questions and caveats highlight just how little medical and scientific evidence exists to make the case against mass inoculation a no-brainer. “The medical, scientific community has to sit down and say, what are really the costs and benefits here?” says Moalem. “It’s been turned into a public health issue and everyone’s trying to spin it their own way and most cancer doctors will tell parents, why would you risk having your child get cervical cancer if I can give you a vaccine to prevent it? But they don’t know what the long-term costs are.”

Her strong recommendation is for parents to talk to their children about HPV as a sexually transmitted virus, and its link to cervical cancer, among other illnesses. “It’s much easier as a parent to get your child to have a vaccine than to sit down and have a conversation and say, using condoms can reduce HPV exposure, therefore that reduces cervical cancer. I’ll just give you a shot, then we don’t have to talk about it,” she says. Moalem believes the original marketing of Gardasil as the vaccine against cervical cancer has been misleading. “That’s not what this is. This is a vaccine against a sexually transmitted disease. I think that’s what people should be very clear on. That really would change the frame of the debate.”

Until more medical and scientific analysis illuminates just what Gardasil will do to young girls, Krueger is wary. “We have a virus here that has so many different types and affects so many body systems that it’s just very complex. The fact that we have a vaccine against HPV types that cause cervical cancer is a medical breakthrough,” he says, but then adds, “My girls will not be vaccinated. That’s not just because of deaths or adverse effects, it’s because of all these unknowns.”

With Lianne George and John Intini

©2012 An Inconvenient Woman. All Rights Reserved.

The International Agency for Research on Cancer (IARC) is part of the World Health Organization.
IARC’s mission is to coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop scientific strategies for cancer prevention and control. The Agency is involved in both epidemiological and laboratory research and disseminates scientific information through publications, meetings, courses, and fellowships.
Cervical cancer is a major global public health problem affecting socioeconomically deprived populations. It is the most
common cancer among women in low-resource countries where 85% of the global cervical cancer burden of
approximately 493 000 cases and 273 000 deaths are found annually. While HPV vaccines have been launched
recently to prevent infection by the two major types of HPV causing cervical cancer, cervical cancer prevention will still
need to rely on early detection of cervical cancer precursors by screening for several years before the full impact from
affordable and efficient immunization programmes can be felt. “Cervical cancer deaths need to be prevented urgently in
the developing world to reduce disparities and improve women’s health” said Dr Christopher Wild, IARC Director. For
several decades now, it has been known that the wide-spread use of Pap smear test for screening has successfully and
substantially reduced cervical cancer deaths in developed countries. “However, Pap smear screening has not been
uniformly successful in preventing cervical cancer deaths in many parts of the world, particularly in low- and medium-
resource countries, due to several challenges in providing good quality testing and following up women testing positive”,
Dr Wild added.

Recognising the need for a more practical and effective approach to screening and early detection of cervical cancer in
developing countries, Dr Rengaswamy Sankaranarayanan, Head of the Screening Group at IARC, with Dr Bhagwan
Nene and colleagues from the Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi, India and Dr Surendra Shastri
and colleagues from the Tata Memorial Centre (TMC), Mumbai, India undertook a large randomised controlled trial in
the remote district of Osmanabad in Maharashtra State, India. 131 806 healthy women aged 30-59 were invited to take
part in the study and 32,000 – 34,000 women were randomly allotted to receive either a single round of screening by
HPV testing or visual inspection with 4% acetic acid (VIA) or Pap smear and compared cervical cancer cases and
deaths with those of the 31,500 women allotted to the usual care and health education. Women found positive on any of
the screening tests were investigated with colposcopy and biopsies and those with cervical pre-cancer and cancer
received appropriate treatment.

In this perspective, “the joint effort by the IARC, NDMCH and TMC scientists assumes enormous public health
importance in demonstrating the objectivity, utility and the comparative effectiveness of different screening approaches
in cervical cancer prevention in low- and medium-resource countries” said Dr Rajan Badwe, Director of the TMC.

This is the largest randomised controlled trial of the three screening methods for cervical cancer in a low-resource
setting, carried out in rural India from 2000 to the present. Dr Sankaranarayanan and colleagues found that HPV testing
was more objective and prevented more advanced cervical cancers and cancer deaths, compared with an unscreened
group of women, than the Pap test or visual screening. Fewer subsequent cancers were diagnosed among the HPV test
negative women than among Pap or visual screen negative women. “The significant reduction in advanced cancers and
cervical cancer deaths following a single HPV testing is due to the possibility that HPV screening detected more
precancerous lesions with a high potential of becoming cancer than those detected by visual screening or Pap smear”
said Dr Sankaranarayanan.

“These results emanate from a rigorous study, designed to provide strong scientific evidence, and have benefitted from
substantial community level cooperation, ethical committees inputs and a systematic registration of cervical cancer
cases in the Osmanabad district” said Dr B. Nene, Director of the NDMCH.

Complete data were available for 131,746 women for whom cervical cancer incidence and mortality were analysed. The
results showed 127 cervical cancers cases, 39 advanced cancers and 34 cervical cancer deaths in the HPV screened
group; 152 cervical cancer cases, 58 advanced cancers, and 54 deaths in the Pap smear group; 157 cervical cancer
cases, 86 advanced cancers and 56 deaths in the visual screening group compared with 118 cervical cancers, 82
advanced cancers and 64 deaths in the unscreened control group of women. These results show no significant
reduction in advanced cancers or cervical cancer deaths following VIA or cytology screening, while a significant
reduction in advanced cervical cancers and deaths followed a single round of HPV testing in this low-resource setting.
“The study shows a number of important findings with wide-ranging implications for all countries in the world, including
developed countries” said Dr Wild.

The parallel development of fast, accurate and affordable HPV tests, suitable for use in developing countries, makes
HPV testing a feasible screening approach in low-resource settings and should go hand in hand with further
developments in affordable and effective vaccines to prevent infection by the two major types of HPV responsible for
cervical cancer development. “Although HPV testing will avoid the variation and subjectivity in test interpretation and
minimize efforts required in quality assurance, high participation for screening and treatment of precancers and cancers
are critical to successful screening programmes leading to reduce disease burden in all settings” added Dr Surendra
Shastri, head of preventive oncology at the TMC.

Recommendations
It is of the utmost importance to set up organized screening programs in low-resource populations to reduce the current
high burden of cervical cancer in the near future, parallel to immunization programs when affordable HPV vaccination is
available. For HPV screening to be feasible, low cost, HPV testing should be made available as rapidly as possible.*

Acknowledgements
This study was conducted with active collaboration from the Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi
and Tata Memorial Centre, Mumbai. The study was supported by a generous grant from the Bill & Melinda Gates
Foundation through the Alliance for Cervical Cancer Prevention (ACCP), a group of five international organizations with
a shared goal of working to prevent cervical cancer in developing countries.

*See: Affordable Solutions to Cervical Cancer Threat

Article reference: N Engl J Med 2009;360:1385-94

For more information, please contact
Dr Sankaranarayanan, Head, IARC Screening Group, at sankar@iarc.fr
Nicolas Gaudin, IARC Communications at com@iarc.fr
The International Agency for Research on Cancer (IARC) is part of the World Health Organization. Its mission is to
coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop
scientific strategies for cancer control. The Agency is involved in both epidemiological and laboratory research and
disseminates scientific information through publications, meetings, courses, and fellowships.
If you wish your name to be removed from our press release e-mailing list, please write to com@iarc.fr.

World Health Organization
International Agency for Research on Cancer Organisation mondiale de la Santé Centre international de Recherche sur le Cancer
150, cours Albert-Thomas 69372 Lyon Cedex 08 (France)
Telephone: 33 472 738 485     Facsimile: 33 472 738 311     http://www.iarc.fr

©2012 An Inconvenient Woman. All Rights Reserved.

I have taken this definition and discussion of the Coloscopy proceedure from one of my favorite online resources, W i k i p e d i a. The copy contains text links to other definitions within Wikipedia.

Colposcopy is a medical diagnostic procedure to examine an illuminated, magnified view of the cervix and the tissues of the vagina and vulva. Many premalignant lesions and malignant lesions in these areas have discernible characteristics which can be detected through the examination. It is done using a colposcope, which provides an enlarged view of the areas, allowing the colposcopist to visually distinguish normal from abnormal appearing tissue and take directed biopsies for further pathological examination. The main goal of colposcopy is to prevent cervical cancer by detecting precancerous lesions early and treating them. The procedure was developed in 1925 by the German physician Hans Hinselmann.

Indications for colposcopy

Most women undergo a colposcopic examination to further investigate a cytological abnormality on their pap smears. Other indications for a woman to have a colposcopy include:

• assessment of diethylstilbestrol (DES) exposure in utero,
• immunosuppression such as HIV infection, or an organ transplant patient
• an abnormal appearance of the cervix as noted by a physician.

Many physicians base their current evaluation and treatment decisions on the report “Guidelines for the Management of Cytological Abnormalities and Cervical Cancer Precursors”, created by the American Society for Colposcopy and Cervical Pathology, during a September 2001 conference.^[1]

The procedure

During the initial evaluation, a medical history is obtained, including gravidity (number of prior pregnancies), parity (number of prior deliveries), last menstrual period, contraception use, prior abnormal pap smear results, allergies, significant past medical history, other medications, prior cervical procedures, and smoking history. In some cases, a pregnancy test may be performed before the procedure. The procedure is fully described to the patient, questions are asked and answered, and she then signs a consent form.

A colposcope is used to identify visible clues suggestive of abnormal tissue. It functions as a lighted binocular microscope to magnify the view of the cervix, vagina, and vulvar surface. Low power (2× to 6×) may be used to obtain a general impression of the surface architecture. Medium (8× to 15×) and high (15× to 25×) powers are utilized to evaluate the vagina and cervix. The higher powers are often necessary to identify certain vascular patterns that may indicate the presence of more advanced precancerous or cancerous lesions. Various light filters are available to highlight different aspects of the surface of the cervix. Acetic acid solution and iodine solution (Lugol’s or Schiller’s) are applied to the surface to improve visualization of abnormal areas.

Colposcopy is performed with the woman lying on her back, legs in stirrups, and buttocks at the lower edge of the table (a position known as the dorsal lithotomy position). A speculum is placed in the vagina after the vulva is examined for any suspicious lesions.

Three percent acetic acid is applied to the cervix using cotton swabs. The transformation zone is a critical area on the cervix where many precancerous and cancerous lesions most often arise. The ability to see the transformation zone and the entire extent of any lesion visualized determines whether an adequate colposcopic examination is attainable.

Areas of the cervix which turn white after the application of acetic acid or have an abnormal vascular pattern are often considered for biopsy. If no lesions are visible, an iodine solution may be applied to the cervix to help highlight areas of abnormality.

After a complete examination, the colposcopist determines the areas with the highest degree of visible abnormality and may obtain biopsies from these areas using a long biopsy instrument. Some doctors consider anesthesia unnecessary, however, many colposcopists now recommend and use a topical anesthetic such as lidocaine or a cervical block to diminish patient discomfort, particularly if many biopsy samples are taken.

Following any biopsies, an endocervical curettage (ECC) is often done. The ECC utilizes a long straight curette to scrape the inside of the cervical canal. The ECC should never be done on a pregnant woman. Monsel’s solution is applied with large cotton swabs to the surface of the cervix to control bleeding. This solution looks like mustard and becomes black in color when exposed to blood. After the procedure this material will be expelled naturally: women can expect to have a thin coffee-ground like discharge for up to several days after the procedure.

Complications

Significant complications from a colposcopy are not common, but may include bleeding, infection at the biopsy site or endometrium, and failure to identify the lesion. Monsel’s solution and silver nitrate interfere with interpretation of biopsy specimen, so these substances should not be applied until all biopsies have been taken. Most patients experience some degree of pain during the curettage, and almost all experience pain during the biopsy.

Follow up

Adequate follow-up is critical to the success of this procedure. Human Papilloma Virus (HPV) is a common infection and the underlying cause for most cervical dysplasia. Women should be counseled on the benefits of safe sex for reducing their risks of contracting and spreading the HPV virus.^[2] One study suggests that prostaglandin in semen may fuel the growth of cervical and uterine tumours and that affected women may benefit from the use of condoms.^[3][4]

Smoking predisposes women to developing cervical abnormalities. A smoking cessation program should be part of the treatment plan for women who smoke.

Without proper treatment, minor abnormalities may develop into cancerous lesions. Various treatments exist for significant lesions, most commonly cryotherapy, loop electrical excision procedure (LEEP), and laser ablation.

References

1. ^ JAMA 2001 Consensus Guidelines for the Management of Women With Cervical Cytological Abnormalities
2. ^ New England Journal of Medicine Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women
3. ^ “Semen ‘may fuel cervical cancer’”. BBC. 2006-08-31. http://news.bbc.co.uk/2/hi/health/5303054.stm. Retrieved on 2007-12-02.
4. ^ “Semen can worsen cervical cancer”. Medical Research Council (UK). http://www.mrc.ac.uk/NewsViewsAndEvents/News/MRC002621. Retrieved on 2007-12-02.

©2012 An Inconvenient Woman. All Rights Reserved.

The Fox News reporter Heidi Hemmit conducted a solid, well-balanced interview of two Denver teens, and their moms about the adverse side effects they suffered after their first Gardasil shot. Cori and Ashely talked about their personal experiences since their Gardasil shot. The primary message is informed choice. Women need to base their decisions about Gardasil not on a hip marketing jingle, but on some solid research. Cervical cancer is not the clear and present danger that Merck has indicated. Regularly scheduled PAP test have mitigated the Cervical cancer threat. HPV usually self-resolves in healthy well nourished bodies. Ask yourself, is Gardasil the answer to a problem that has already been solved by other means. In my opinion, Gardasil is a superfoulus solution.

©2012 An Inconvenient Woman. All Rights Reserved.