Bonus Lobbying Victory: European regulators give Gardasil nod for use in women up to the age of 45

Last week was good to Merck’s hopes for an improved bottom line next quarter. It was a very a disappointing week for those of us who feel the HPV vaccine has the potential to do more harm than good, and continues to preempt scarce public health funds better used for more effective programs, like universal access to PAP Tests.

Merck’s FDA and European Gardasil market-expansion victory was some what muted by its potential competitor, GSK’s Cervarix own good news as it inches  closer to FDA approval. Merck has used all of its Federal regulatory lobbying influence to delay FDA approval of Cervarix for the American market.

Merck actively sought new indications for Gardasil to help combat falling sales of their human papillomavirus shot

Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.

A few panelists–and at least one analyst–point out that approval for use in males doesn’t necessarily mean males will use it. The series of three shots is expensive, around $400, and will require three visits to the doctor over a six-month period…to prevent a nonfatal venereal disease. “Pretty much no healthy teen would ever do that,” Tim Anderson, analyst with Sanford C. Bernstein, told the New York Times.  (Good point Tim. The more cynical amongst those of us, who have fought use of Garasil  since the beginning, are wondering if, even now, the Merck marketing team is not trying to whip up false scare tactics that will herd fathers into take their sons in to doctor’s offices in massive numbers — after all, those catchy, cute commercials worked to move hundreds of thousands of well meaning mothers to contribute to those fat bonuses Merck Execs passed out in 2006 and 2007.)

Merck is expected to argue for vaccination of boys and young men in part to help protect girls and young women. But it remains to be seen whether that “herd immunity” argument will work on parents and insurers who have to pay for the shot.

The European approval, meanwhile, addresses cervical cancer, which is potentially fatal. [Sandi note: Merck's phasing, not mine. Cervical cancer is potentially, but rarely fatal if women have regular PAP tests after they become sexually active.] In Europe, the vaccine is marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis. European regulators gave the nod to expand use of Gardasil to women up to age 45, when previously it was only indicated for those up to age 26.

This new expansion gambit is a complete mystery. In 2006 the rational used by Merck lobbyists for vaccinating school-girls as young as age 10 was that the HPV-vaccine Gardasil was not effective once the girls were exposed to HPV via sexual activity. Hundreds of thousand of girls have been herded into doctor’s offices by mothers and State regulators on the promise of lifetime protection from cervical cancer.  As more non-marketing information became available, questions that should have been asked and answered BEFORE approval began to be discussed. Dr. Diane Harper, one of the designers of the early trials, questioned the long-term effectiveness of the vaccine and raised the possibility of booster shots needed just at the age when young women became sexually active.  Based on Merck rational for expanding Gardasil usage for women up to their mid-forties, why do we continue to put young girls at risk with a vaccine with a history of adverse effects and has been tied to the deaths of young healthy girls.

In the U.S., the FDA has asked Merck for more data on Gardasil use in women 27 to 45 years old; the company expects to provide that info by the end of this year. Mother’s need to watch this like hawks. Read the FDA rational and the Merck aguments for expansion.  The money spent enriching Merck executives is far better used expanding access to PAP tests.

Sources:

Read Full NYT story: Two Giants Vie for Billions in S.T.D. Vaccine Market:

Read Full Story from CNNHealth.com: FDA panel urges HPV vaccine be given to boys

Read Wall Street Journal article: FDA Panel Backs Cancer Vaccines

©2012 An Inconvenient Woman. All Rights Reserved.

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.

Fresh controversies are heating up over the marketing of products to prevent cervical cancer

The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should be approved for use in boys, who can be HPV carriers. The same panel will also advise the agency on whether it should allow a new HPV vaccine, GlaxoSmithKline (GSK)’s Cervarix, to enter the U.S. market. The FDA doesn’t have to follow its panels’ recommendations, but it usually does.

Sales of Gardasil to prevent cervical cancer hit a respectable $1.4 billion last year, but they are already starting to slump, and fresh controversies could pour more cold water on this whole class of vaccines. Ever since Gardasil was approved in 2006, health-care watchdogs have griped that Merck has been overselling the vaccine’s cancer-beating power without having a full understanding of potential long-term risks. On Aug. 19, Columbia University professors Sheila M. and David J. Rothman published an article in the Journal of the American Medical Assn. blasting the company for paying grants to medical organizations that are strong advocates for vaccination. “Telling every mom she needs to get her daughters vaccinated to protect them from cancer is creating a market out of thin air,” David Rothman says. “They’re already protected” through regular pap smears, he adds.

Such criticisms mark a stark turnabout for a product once hailed as a breakthrough. Cervical cancer is a scourge: 11,000 cases are expected to be diagnosed this year, and 4,000 women will probably die of the disease, says the National Cancer Institute. The vaccine could prevent more than 70% of such cases. But from Day One, Merck has been lambasted for tactics such as lobbying lawmakers to make vaccination mandatory. After a strong start in the first two years, Gardasil sales fell 5% in 2008 and second-quarter sales are down 18% from a year earlier.

Dr. Richard M. Haupt, who heads the Gardasil research program for Merck, defends the company’s marketing. “Our goal is to act in the best interest of public health,” he says, noting that many organizations have spent money to promote the cause. Should boys be vaccinated? Merck has given the FDA data showing Gardasil prevents 90% of HPV symptoms in men, but since related male cancers are rare, the main justification is to protect their partners from cervical cancer. (Gathering data is also dicey because even if there were a drop-off in cases after widespread male vaccination, Merck could never prove its vaccine deserved more of the credit than, say, improved screening.)

Glaxo, for its part, doesn’t plan to market Cervarix to boys because it doesn’t think the strategy would be worth the expense. The Centers for Disease Control estimates that vaccinating males would cost the health-care system at least twice as much per year of added life as it costs to vaccinate females.

As for payments to medical organizations, Glaxo, Merck, and their beneficiaries say their disclosures are adequate. Two recipients, the American College of Obstetricians & Gynecologists and the Society of Gynecologic Oncologists, say they put the money to many uses beyond endorsing a specific vaccine. Meanwhile, Merck’s Haupt says the scandals are drawing attention away from what could be a public health boon. “I vaccinated both my daughters,” says the father of four. And if Gardasil is approved for boys, he says, “I plan to vaccinate both my sons.”

Arlene Weintraub is a senior writer for BusinessWeek‘s Science & Technology department and published this article in Businessweek, online August 27th, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

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.

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.

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.
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.

In a July 9th story, ‘WHO clears Glaxo’s Cervarix for developing world’ Reuters reported that  GlaxoSmithKline’s (GSK.L) cervical cancer vaccine Cervarix has won a green light from the World Health Organisation (WHO) for use in developing countries, although how the shot will be paid for has yet to be resolved.

WHO “prequalification” —  a key hurdle for gaining wider use of Glaxo’s HPV vaccine Cervarix, an necessary endorsement for UN agencies and the non-profit GAVI Alliance to purchase the vaccine, and Glaxo said on Thursday it hoped the move would help speed access to Cervarix globally.

And Glaxo quickly followed up, saying that the company plans to explore new financing mechanisms that would ensure broad availability. “We’re exploring a variety of distribution partnerships to ensure Cervarix will protect women and girls around the globe,” Jean Stephenne, head of vaccines, tells Reuters.

WHO had already approved Gardasil and the Global Alliance for Vaccines and Immunization, a broad umbrella group of international health organizations, has made access to cervical cancer vaccines a top priority. Dan Thomas, a GAVI spokesman stated “We’re very eager to offer women in developing countries these vaccines because without early screening, they are arguably more vulnerable to cervical cancer.”

It’s likely that Glaxo will work out discount prices for global health agencies and nonprofits, a common avenue for Big Pharma companies selling expensive therapies in poor countries.

For full Reuters story Click here: http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709

For AP Coverage, ‘WHO approves cervical cancer vaccine Cervarix’ Click Here:

http://www.google.com/hostednews/ap/article/ALeqM5gLW3aCaSxKeKddyL_g7p2uerLjkgD99AT25G0

©2012 An Inconvenient Woman. All Rights Reserved.

LONDON (Reuters) – GlaxoSmithKline Plc’s Cervarix is the first product of its kind to show it protects against the five most common cervical cancer-causing viruses, Europe’s biggest drug company said in a statement on Tuesday.

A study, published in Tuesday’s issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types.

Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone.

“This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection … beyond what had at first been anticipated,” said Thomas Breuer, head of global clinical R&D at GSK Biologicals.  Click here for the full article published by Reuters.

©2012 An Inconvenient Woman. All Rights Reserved.