Cervical cancer vaccine: Older woman are not as likely to benefit from HPV vaccine

Older Women Are Not Likely to Benefit From Cervical Cancer Vaccine

New York, NY

Women older than 40 are unlikely to get much benefit from the vaccine for the virus that causes cervical cancer, a new study reports.

The vaccine for human papillomavirus, or HPV, is recommended for women up to age 26 and girls as young as 9. To determine whether older women might be protected as well, the new study looked at patterns of HPV infection as women age, said Dr. Ana Cecilia Rodríguez, the lead author of the new paper, published online Feb. 15 in The Journal of the National Cancer Institute. The study followed more than 9,000 Costa Rican women ages 19 to 97, screening them for carcinogenic HPV infections and precursors to cervical cancer. The rate of newly detected infections dropped with age — to 13.5 percent in women 42 and older, from 35 percent in women 18 to 25. In younger and older women alike, new infections generally cleared up without treatment, usually within two years.

Although cervical cancer is more common in older than in younger women, it develops decades after the initial infection with a carcinogenic virus, explained Dr. Rodríguez, of the Inciensa Foundation, a Costa Rican health and nutrition institute, whose work was supported by the National Institutes of Health in the United States.

“Because the HPV vaccine can only prevent infections, and these women are not getting that many new infections, the potential benefit of HPV vaccination among older women is very limited,” she said.

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Dolphins may be ideal model to study human cervical cancer

Dolphins could help cure cervical cancer

Miami,FL

Veterinarians from the University of Florida say that dolphins may be an ideal model to study human cervical cancer.

"We discovered that dolphins get multiple infections of papillomaviruses, which are known to be linked with cervical cancer in women," said marine biologist Hendrik Nollens in a news release. "Dolphins are the only species besides humans that we know of that can harbor coinfections, or infections of multiple papillomavirus types, in the genital mucosa."

There are approximately 100 types of human papillomaviruses.

Nollens also said that there is evidence that some infections can go from the sea to the land, which could even mean that a high-risk infection such as SARS or the West Nile virus could come from marine animals.

However, Nollens said that there is no evidence that dolphins get cervical cancer from papillomaviruses.

"Why do people develop the disease, but dolphins don't? If we can figure out why, the human medical community might be very interested in how that information might be applied to human strategies for preventing the disease," he said.

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Less frequent Pap tests now recommended for cervical cancer screening

New York, NY

Initial cervical cancer screening should begin at age 21 and can be rescreened less frequently than previously recommended, according to newly revised, evidence-based guidelines issued recently by The American Congress of Obstetricians and Gynecologists (ACOG).* Most women younger than 30 should undergo cervical screening once every two years instead of annually, and those age 30 and older can be rescreened once every three years. Annual gynecological visits are still recommended and important for a woman's overall health.

Cervical cancer rates have fallen more than 50 percent in the past 30 years in the United States, believed to be due to the widespread use of the Pap test. The incidence of cervical cancer fell from 14.8 per 100,000 women in 1975 to 6.5 per 100,000 women in 2006. The American Cancer Society estimates that there will be 11,270 new cases of cervical cancer and 4,070 deaths from it in the United States in 2009. The majority of deaths from cervical cancer are among women who are screened infrequently or not at all. Cervical cancer is a slow growing malignancy caused by certain strains of the human papillomavirus (HPV). HPV also is responsible for genital and anal warts, as well as oral and anal cancer.

"The tradition of doing a Pap test every year has not been supported by recent scientific evidence," says Dr. Alan G. Waxman of the University of New Mexico. Review of the literature shows that screening at less frequent intervals prevents cervical cancer just as well, with less incurred costs, and avoids unnecessary interventions that could be harmful, especially to reproductive aged women.

ACOG now recommends that women from ages 21 to 30 be screened every two years instead of annually. Women 30 and older who have had three consecutive negative cervical cytology test results (Pap smears) may be screened once every three years. Women with certain risk factors may need more frequent screening, including those who have HIV, are immunocompromised, were exposed to diethylstilbestrol (DES) in utero, and have been treated for cervical intraepithelial neoplasia (CIN) 2, CIN 3 (both pre-malignancies of the cervix), or cervical cancer.

Moving the baseline cervical screening to age 21 is a conservative approach to avoid unnecessary treatment of adolescents, which may have economic, emotional, and future adverse childbearing implications. ACOG previously recommended that cervical screening with Pap smears begin three years after first sexual intercourse or by age 21, whichever occurred first. Although the rate of HPV infection is high among sexually active adolescents, invasive cervical cancer is rare in women under age 21. The immune system clears the HPV infection within one to two years among most adolescent women. Because the adolescent cervix is immature, there is a higher incidence of HPV-related precancerous lesions, called "dysplasia." However, the large majority of cervical dysplasias in adolescents spontaneously resolve without any treatment. This means in this age group there may be a higher number of false-positives that are followed by more invasive tests or more frequent Pap smears.

A significant increase in premature births has recently been documented among women who have been treated with excisional procedures for dysplasia, called cold-knife cone excision or LEEP excision, in which a portion of the cervix is surgically removed either in the office or operating room. Adolescents have their childbearing years ahead of them, and surgically treating the cervix with such excisional procedures has been shown to adversely affect their pregnancies. Therefore, it's important to avoid unnecessary procedures. We argue that early screening for cervical cancer in adolescents only serves to increase their anxiety, and may lead to overuse of procedures for a disease that has shown to resolve usually on its own.

Routine cervical cytology testing should be discontinued in women (regardless of age) who have had a total hysterectomy (removal of the cervix along with the uterus) for noncancerous reasons, as long as they have no history of high-grade dysplasia.

ACOG's recommendations on the upper age limit for discontinuing cervical screening remain the same. It is reasonable to stop cervical cancer screening by age 70 among women who have three or more consecutive negative Pap smear results and no abnormal test results in the past 10 years. ACOG also recommends that women who have been vaccinated against HPV should follow the same screening guidelines as unvaccinated women.

Of importance to impress on our patients is that annual gynecologic examinations are still appropriate and recommended, even if cervical screening with a Pap smear is not performed at each visit. There's more to a visit to the gynecologist than just the Pap smear.

Why should you believe this study? ACOG is the nation's leading group of professionals providing health care for women. Recommendations are evidence based and highly regarded among health care professionals. www.acog.org

*ACOG is formerly known as The American College of Obstetricians and Gynecologists.

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Having sex at an early age can double risk of cervical cancer

London, UK

A study shows women are at greater risk from the disease by becoming sexually active at a young age, prompting campaigners to call for the screening age limit to be lowered

The study published in the British Journal of Cancer into why poorer women have a higher risk of the disease found they tended to have sex four years earlier than more affluent women.

In England, women do not qualify for NHS screening until they reach 25, perhaps ten years after they may have contracted HPV, the sexually transmitted virus that causes most cases of cervical cancer.

The age at which a woman had her first baby was also an important factor, according to the study of 20,000 women by the International Agency for Research on Cancer.

But smoking and the number of sexual partners did not account for any of the difference.

Dr Silvia Francheschi, who led the study, said the risk of cervical cancer was higher in women who had their first intercourse aged 20, compared with 25.

She said: “In our study, poorer women become sexually active on average four years earlier. So they may also have been infected with HPV earlier, giving the virus more time to produce the long sequence of events that are needed for cancer development.”

Women aged between 25 and 49 are offered checks every three years in England, while women aged 50 to 64 get five yearly checks for pre cancerous changes that could develop into cancer without treatment.

Dr Lesley Walker, of Cancer Research UK, said: “These results back up the need for the HPV vaccination to be given in schools at an age before they start having sex, especially among girls in deprived areas.”

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HPV vaccine rates low in United States, Univ. of Mich. study finds

Ann Arbor, MI

The use of the vaccine to prevent human papilloma virus (HPV) was found to be very low in the United States in a study conducted by Amanda Dempsey, M.D., PhD, MPH, of the University of Michigan and published in the journal Vaccine.

Dr. Dempsy analyzed factors associated with adolescent HPV vaccine use and reports variation by insurance type, race, type of visit, and whether the health care provider was a pediatrician, gynecologist or family medicine doctor.

These are Dr. Dempsey’s results verbatim:

Researchers looked at HPV vaccination rates among nine to 18 year-old patients seen at 20 university-affiliated outpatient clinics in southeast Michigan in three medical specialties family medicine, pediatric and gynecological clinics.

The study found:

Overall HPV vaccine use was low among adolescents. Among girls who were eligible to have received all three doses in the vaccination series, only 15 percent did so. This finding is consistent with a national study showing low vaccine series completion among 13 to 17 year-olds in 2007.

Even though overall uptake of the vaccine among adolescents was low, once the vaccine series was initiated there was a relatively high likelihood they would receive all three doses, with more than three quarters of those eligible getting second and third doses.

Despite recommendations from the Advisory Committee on Immunization Practices for universal vaccination of all 11-12 year old females against HPV, this age group was significantly less likely to initiate the vaccine series when compared to 13-15 year-olds, or those over the age of 16. However, among girls that did initiate the series, all three age groups had a similar likelihood of being fully vaccinated with all three doses.

Gynecologists were less likely to initiate the vaccine series than pediatricians or family practitioners. However, after the three-dose series began, there were no statistical differences in series completion among patients seen at each medical specialty.

Most adolescents received the first dose of vaccine at a "well child check up." Subsequent doses of vaccine were typically provided at "immunization only appointments," where the patient receives the vaccine from a nurse and has no interaction with a doctor. However, this pattern varied by age. The older an adolescent, the more likely they were to receive second and third doses at a "sick visit" with the doctor.

Researchers also found disparities in series completion by race and insurance status. The fact that minorities and those with public health insurance were less likely to be completely vaccinated raises questions about the degree to which HPV vaccination will impact cervical cancer rates in the U.S. since these groups are already known to be at higher risk for developing cervical cancer, Dempsey says.

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Will cutting back on teen Pap tests result in more STDs?

Atlanta, GA

Teen girls can skip Pap tests, according to new guidelines that say women should start cervical cancer screening at age 21. But some experts are concerned that rates of sexually transmitted diseases or unplanned pregnancies could increase without the Pap test to prompt a doctor's visit.

As it stands, as many as one in four U.S. teenage girls has had an STD at some point in her life, often soon after she becomes sexually active, according to research published this week in Pediatrics.

"I am concerned that without the recommendation for young women to get Pap smears early on, they will lose important opportunities to seek advice and to learn about their health -- particularly their sexual health -- at a time in their lives when they need it most," says Kimberly Spector, an adolescent-health educator in Los Angeles, California. "Regardless of the tests performed during a gynecologist visit, the conversation regarding sexual health risks and preventative measures can be very informative and empowering for young patients."

In the past, women were told to start Pap tests, which can detect abnormal cells in the cervix, three years after becoming sexually active or at age 21 -- whichever came first. However, these abnormal cells often go away on their own, particularly in young women. If they don't, such cells grow so slowly that catching them at age 21 is still early enough to remove them before they become cancerous. And catching them sooner could lead to unnecessary tests and treatments that sometimes damage the cervix, increasing the risk for a premature birth later in life.

The new guidelines still recommend that girls who are under 21 see a gynecologist; they just don't need Pap tests, according to the American College of Obstetricians and Gynecologists. The fear, however, is that some teens may misinterpret the new rules and miss out on important discussions about contraception and protection against STDs such as gonorrhea, bacterial vaginosis, chlamydia, and human papillomavirus.

"If women hear that they no longer need Pap tests annually or until they are 21, perhaps they wouldn't seek any preventive health care, and whether this results in decreased screening and identification of chlamydia and other STDs remains to be determined, but it is concerning," says Harold Wiesenfeld, M.D., the director of the division of reproductive infectious diseases at the University of Pittsburgh School of Medicine, in Pennsylvania.

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Many STDs, including chlamydia and gonorrhea, have no symptoms. "Unless screened, young women will remain undiagnosed, untreated, and at risk for complications, including pelvic inflammatory disease, which results in infertility," says Wiesenfeld, who is also an associate investigator at Magee-Womens Research Institute, in Pittsburgh. "[Still] the Pap test is not the 100 percent trigger to do chlamydia screening," he says. "We need to do a better job about STD screening overall."

Teens who are sexually active should use contraception and take steps (such as using condoms) to prevent STDs, even if they don't need Pap tests, says Alina Salganicoff, Ph.D., the vice president and director of women's health policy for the Henry J. Kaiser Family Foundation, an advocacy group based in Menlo Park, California.

Health.com: Who's most at risk for STDs?

"We are going to have to pay special attention to how we educate our adolescent patients about contraception and STD prevention," she says.

However, most experts agree that Pap tests are indeed unnecessary for younger women and that the new guidelines will not put them at risk. Most also agree that the new guidelines are not an effort to limit care.

"I do not fear the consequences because these guidelines are well thought out and give us a great opportunity to focus on who is at risk for cervical cancer," says Bobbie Gostout, M.D., the chair of the department of obstetrics and gynecology at the Mayo Clinic, in Rochester, Minnesota.

"Cervical cancer screening is very important, but we are getting smarter at screening," she says. "We are backing off from screening those that have less to gain from it." The cervical guidelines, which recommend that sexually active teens still be counseled and tested for STDs (although a pelvic exam might not be necessary), "hit it right," she says.

Teens who have received human papillomavirus vaccines, such as Gardasil, are protected against several HPV strains that are linked to many, but not all, cervical cancers and to genital warts. These types of vaccines may eventually reduce cervical cancer rates even further (rates have been dropping since the 1970s), although experts say the impact won't be seen for 10 to 15 years. Therefore, girls and women given the HPV shot need to have Pap tests starting at age 21 and every two years after that, just like those who haven't had the shot.

The Centers for Disease Control and Prevention has added Gardasil to its routine childhood vaccine schedule. It recommends that Gardasil, which is administered in three doses, be given to all girls ages 11 and 12, and even for girls as young as 9, with catch-up doses for girls and women ages 13 to 26 who haven't been vaccinated.

"We know that the HPV types targeted by the new vaccine are linked to cervical cancers that tend to occur five years earlier than cervical cancers caused by other HPV types," Gostout says. "So once adolescents are well vaccinated against HPV, we should have even more confidence in eliminating Pap tests in younger women."

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"We are now rolling out the vaccine, and clearly the first group that will experience broader protection is young women," agrees the Kaiser Family Foundation's Salganicoff. "The HPV vaccine is a really important step that young women can take in terms of protecting themselves against HPV and subsequent cervical cancer."

Ideally, teens should have an HPV shot and see a gynecologist for counseling about STDs before they become sexually active, experts say. HPV vaccines don't protect women who have already been infected with the virus.

"Ideally, women need to establish a relationship with a reproductive health provider before they become sexually active," Wiesenfeld says.

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Cervical cancer testing guidelines revised

Washington, D.C.

A national physician’s organization has revised its cervical cancer screening guidelines, saying that women in their 20s can have a Pap smear every two years, instead of every year.

The statements follow closely after the start of an ongoing discussion on regular mammograms, stemming from debate on when women should start having the procedure — in their 40s or 50s.

The proximity of the two items has prompted some to worry about a perceived drift toward future health care rationing, fueled by debate over health care reform.

But the American College of Obstetricians and Gynecologists, which released the new cervical cancer guidelines last week, said women younger than 21 are at very low risk of cancer — and screening them may lead to “unnecessary and harmful evaluation and treatment.”

The organization said women should have their first cervical cancer screening at age 21 and can be rescreened less frequently than previously recommended. The new guidelines say most women younger than 30 should undergo cervical screening once every two years instead of annually.

Those age 30 and older can be rescreened once every three years, according to an ACOG news release.

Abilene physician Peter Norton said that in some ways, issues behind the new guidelines stretch back to the 1940s. In 1945, the test gained the support of the American Cancer Society.

Cervical cancer is a slow-growing cancer caused by certain strains of the human papillomavirus (HPV), a common sexually transmitted disease among women and men that also causes genital and anal warts, as well as oral and anal cancer.

“It’s the first time you really know the cause of a cancer — that it’s a virus,” Norton said.

The ability to discover abnormalities earlier, and to find premalignant cells early on, sounds “very logical and very good,” he said.

But in the last 10 years, it’s become known that not all of the infections progress to a cancerous state. So a certain percentage of women may not need to be treated at all, since their own immune systems are able to handle the infection.

“When you couple that with the fact that the cervix is important to maintaining a pregnancy to term, anything that we do to treat premalignant cells might damage the cervix to a certain extent,” he said. “So that becomes an issue.”

All such things considered, Norton worried that because of the suggested guidelines, some patients would be left untreated, leaving them open “to expose other people to HPV.”

“That’s not isolating the disease the way infectious diseases have been traditionally isolated,” he said.

Sexual activity — skin to skin contact, not necessarily intercourse — is what spreads HPV, Norton said.

“We know that there are certain groups of women who probably do not need Pap smears,” he said. “I feel age 21 was used because they feel most girls, probably 60 to 80 percent, are going to be sexually active by the time they’re 18 or 19 years old.”

But that number isn’t accurate for everyone, he said.

Women should start receiving Pap smears three years after the initiation of intercourse, he said.

And for some women, waiting as much as three years between screenings might be “too long,” he said.

Cervical cancer rates have fallen more than 50 percent in the past 30 years in the United States because of the widespread use of the Pap test, according to ACOG, which said in its statement that the majority of deaths from cervical cancer in the U.S. are among women who are screened infrequently or not at all.

Vaccination against HPV is expected to cut cervical cancer rates in the future, but for now, ACOG’s guidelines say vaccinated women should follow the same Pap guidelines as those who are unvaccinated.

Norton dubbed it “interesting” that the guidelines were coming out around the time of the national health debate, though ACOG has said that its similarly timed release is simply coincidental.

Helen Teague, coordinator for women’s health/community initiatives with Hendrick Health System’s Vera West Women’s Center, said she worried that both the breast cancer debate and the revised screening guidelines might herald “the beginnings of the rationing of health care.”

Teague said cervical cancer is preventable with screening and she touted the procedure as safe.

“My question in this whole thing, not only with the mammogram suggestion and now this, is why is it advisable to keep women, in this case, young women, in the dark about their health?” she said. “If we have the technology, why aren’t we using it? Why would we delay in using it?”

An initial cervical cancer screening sets an important baseline for future screenings, she said.

“Most of the folks who make these decisions do not see the faces of those these decisions impact,” she said.

Nationally, some sought to connect the mammogram recommendations to the health-care overhaul, contending that such findings are the way that medical rationing starts.

Under the pending legislation, “nothing would prohibit the federal government from deciding if tests, treatments and procedures are too expensive, and therefore, unnecessary,” Sens. Jon Kyl of Arizona, the Republican Whip, and Tom Coburn of Oklahoma, a physician, said in a joint statement.

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Cancer screening guidelines for women questioned

Washington, D.C.

Recent changes in women's cancer screening advice stunned some local health care providers.

Last week, a recommendation issued by the U.S. Preventive Services Task Force said women should generally begin getting routine mammographies at age 50, instead of 40.

The American College of Obstetricians and Gynecologists also recommended limiting cervical cancer screenings to women ages 21 and older, regardless of their sexual history.

Local medical officials question the logic that these new recommendations will prevent unnecessary anxiety and false alarms among younger women.

Wayne Young, director of Battle Creek Health System's The Cancer Care Center, said women in their 40s who are given mammographies are more likely to detect breast cancer at an early stage when it is more treatable.

A mammography is not 100 percent accurate, but it is the best early detection tool physicians have, he said. Abnormal results can be followed with needle biopsies and further tests for cancer.

"It's a little discomfort for some women; for others it will save their lives," he said.

Young said his mother and sister died of breast cancer before age 50. His three daughters will be screened early because of their genetic link, but he wanted all young women to get the best preventive treatment available to them as soon as possible.

His biggest concern is that health insurers will follow these agencies' recommendations and retract coverage for screening younger women, he said.

"That will become an issue because, especially in this economy, that will be an extra out-of-pocket cost and some people will put it off until age 50," he said.

Dr. Kari Formsma, a Battle Creek gynecologist and obstetrician with Pathway Women's Health, said she is concerned about the recommendation to limit cervical cancer screenings regardless of women's sexual history.

She said the guideline fails to acknowledge child sexual abuse and teenage promiscuity.

Cervical cancer is caused by certain strains of the human papillomavirus. It is a sexually transmitted infection that a condom cannot protect against. A woman's risk of developing cervical cancer increases with the number of sexual partners she has.

o it doesn't make sense to say a 21-year-old virgin is at more risk of getting cervical cancer than a 12-year-old victim of sexual abuse who has had multiple partners before age 21, she said.

The American College of Obstetricians and Gynecologists issued the recommendation because cervical cancer takes an average of five years to develop. But that assumes women don't begin having sex until they are 16, Formsma said.

She agreed with the task force's recommendation against teaching breast self-examinations on the grounds that it is often more harmful than not. Women who perform self-exams are more likely to find and be treated for benign lumps, according to the research.

"Breast self-exams, I tell patients to do them if they feel like it," she said. "I'd rather them do things that are a clearly proven benefit, like exercising every day."

She also applauded the move away from annual cervical cancer exams to every two years for women with normal Pap tests.

The money spent on unnecessary exams would do more good testing sexually active teens for infections, she said.

Overall, Formsma recommended patients disclose their full sexual history with their doctor to know how high a risk they have of developing cervical cancer, and then schedule screenings on an individual basis.

Young said the same is true for women in their 40s who are concerned about breast cancer. Women who have a family history of breast cancer or a genetic predisposition should consult their doctor about getting earlier screenings.

"A woman just needs to check with her primary care physician because those people ... can recommend whether she should get a mammogram or not," he said.

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New cervical cancer screening guidelines: No more 'annual' Pap Smear Tests

Washington, D.C.

Doctors Say Young Women Can Wait for First Pap, and Get Them Less Often

Pap smears may no longer be called "annuals" if doctors follow new cervical cancer screening recommendations from the American College of Obstetricians and Gynecologists.

The group announced today that women should start getting cervical cancer screenings at age 21 instead of 18, and that women could wait longer between the screenings -- regardless of when a woman starts having sex.

Women in their 20s with normal Pap smear results now should get screenings every two years instead of every year, and women in their 30s can wait three years between screenings, according to the new ACOG guidelines.

After a week of uproar over the controversial recommendations for less mammogram screenings for women, doctors say they will have to wait and see how the public reacts to the new pap smear guidelines.

"This is not a radical change in screening practices. This is something that's been coming gradually since the 1980s," said Dr. Alan G. Waxman, who helped write the new guidelines.

Some doctors hailed the decision as a way to reduce a host of problems caused by excessive screening; yet, a few others worried it might trigger more women to neglect annual checkups with gynecologists.

Waxman said the move toward fewer screenings will reduce unnecessary treatment in young women and protect them from future pregnancy complications.

On one hand, college-aged women have very high HPV infection rates. Dr. John Curtin, of The Cancer Institute at NYU Langone Medical Center in New York City said 70 percent of all college-aged sexually active people have contracted HPV. These high infection rates translate into a high number of abnormal pap smears.

However, the ACOG guidelines point out that only 0.1 percent of cervical cancer occurs in women under 21 years of age in part, doctors believe, because young women's immune systems are strong enough to fight off HPV before it causes cancer. When dysplasias progress to cancers it's usually a result of older women missing screenings for years at a time; 50 percent of women diagnosed with cervical cancer each year never had a pap smear before, according to the ACOG statement.

And some research has suggested the diagnostic surgery that often follow an abnormal result can pose problems for future pregnancies in some women.

"The driving force behind the change was the numerous studies that show women who are treated for cervical dysplasias are more likely to have a preterm birth," said Waxman, who is a professor at the University of New Mexico in Albuquerque.

Unnecessary HPV Treatment Can Lead to Pregnancy Problems

Waxman explained that the LEEP procedure to remove precancerous tissue often caused by an infection with the human papillomavirus, or HPV, also weakens the cervix. In fact, it's estimated, one in 18 women who've had a LEEP procedure will go on to give birth prematurely.

But, he added, new studies have shown "with most of the cervical abnormalities in adolescents, most of them get better by themselves. ... The thought is that these are the people who have most of their child-bearing years in front of them."

The ACOG recommendations cite studies showing that up to 90 percent of these infections are cleared on their own in adolescents within a few years.

The measure also was intended to reduce anxiety in young women who may struggle with the news that they are infected with a sexually transmitted virus known to cause cancer.

"I was convinced I was dying, that I had cancer. There was not enough education back then," said Nicole C., a resident of La Porte, Texas, who was diagnosed at age 22 with cervical dysplasia -- an abnormal Pap smear -- caused by HPV. "My doctor at the time made me feel horrible about myself, accusing me of not being truthful about how many partners I'd had."

Reducing Anxiety Now and Later On

Nicole, who asked that her last name not be used for privacy reasons, had her first abnormal Pap smear in 1998. As the years passed, more of her friends were diagnosed with cervical dysplasia in their 20s.

As Nicole started serving as an impromptu counselor to explain how HPV is spread, she aimed to soothe fears and reduce the stigma.

"If I had known more back then, I would not have freaked out about it," she said. "I wished they had done that [changed the guidelines] years ago."

Many doctors say they recognize the same anxiety on their young patients' faces.

"Yes, the diagnosis of an abnormal Pap can cause emotional distress to an adolescent girl, and I have certainly seen that," said Dr. Elizabeth Alderman of Montefiore Medical Center in the Bronx, N.Y. "[Cervical biopsies] and repeat Pap smears with visits cost a lot of money."

In fact, some doctors felt the new recommendations did not go far enough.

Dr. Diane Harper of the University of Missouri-Kansas, who specializes in HPV infections, felt that ACOG is behind the other recommending bodies in the United States that argue screening should start at age 25, not age 21.

"There is ample evidence that screening earlier than 25 years is only costly with many false positives," said Harper. "The rest of the world is going to an every-five-or-six-year screening interval ... and ACOG is now just endorsing the three-year interval for HPV negative and Pap negative [women]."

Doctors speaking to ABCNews.com also said they felt the best way to prevent more cancer deaths wasn't to re-screen women who are already seeing doctors regularly, but to try to get women who aren't getting screenings at all into the doctors.

"Whether we screen everybody every two or three years isn't probably not going to make a big difference I don't think, just as long as they are getting screened," said Curtin. "The fact remains there are unscreened patients and they are at risk for cancer."

Doctors speaking to ABCNews.com also said they felt the best way to prevent more cancer deaths wasn't to re-screen women who are already seeing doctors regularly, but to try to get women who aren't getting screenings at all into the doctors.

"Whether we screen everybody every two or three years is probably not going to make a big difference, just as long as they are getting screened," said Curtin. "The fact remains there are unscreened patients and they are at risk for cancer."

Negative Effects of Fewer Pap Smears Unknown

On the other hand, many women admit that the only reason they go to a doctor is for an annual Pap smear and contraception. For those reasons, some doctors worry such women won't receive any medical checkups at all.

"Honestly, the first time it was discovered, I was going to Planned Parenthood for contraception because I had just become sexually active. It was only my second partner," said Alicia, a 32-year-old woman from New Orleans who also did not want her last name used.

Alicia had her first abnormal Pap smear when she was 18.

"I cried, and I really, really freaked out," she said.

But the task of treating her abnormal Pap smears made her aware of her health.

"That was a pivotal moment in my life," she said. "I started doing things better. I started getting into gardening and doing things to calm down."

Dr. Donnica Moore, president of Sapphire Women's Health Group and an obstetrician-gynecologist by training, worried that the new guidelines might keep women who've had a normal Pap smear, or no symptoms, away from the doctor.

"Women may now assume -- incorrectly -- that if they only need a Pap smear every two or three years, then they only need to see their gynecologist every two to three years, and for many of these women, their gynecologist is their primary care physician," said Moore. "Thus, they will not be getting a routine physical, breast exam, blood pressure measurement, and sexually-transmitted infection testing."

Changing Recommendations on Pap Smears
However, Friday's changes aren't the first to affect cervical cancer screenings. Over the years, doctors have scaled back on cervical cancer screening schedules after more research proved less frequent screenings were effective.

"It is about time this occurred," said Dr. Mark Einstein of the Montefiore Medical Center in the Bronx, N.Y. "Oftentimes, young women are put into a 'high-risk' category, clinically, because they have a [positive] Pap test that is essentially just a sign of an HPV infection -- but it is not clinically relevant. This leads to anxiety and over-testing."

Dr. Joanna Cain of Brown University agreed, and argued that the HPV vaccine will further decrease the transmission of the virus that is responsible for up to 70 percent of cancers in the coming years.

Below is a timeline of changes to cervical cancer screenings over the years, according to Waxman:

1957 -- The American Cancer Society runs a nationwide campaign for women to get a Pap test every year.

1976 -- Canadian health leaders examine data and recommend a woman get a Pap smear every two years, after a woman has three consecutive normal Pap smears.

1980 -- The American Cancer Society follows Canadian guidelines recommending a woman get a Pap smear every two years after three consecutive normal Pap smears.

1988 -- The American College of Obstetricians and Gynecologists recommends starting screening at 18, or with the onset of sexual activity and getting a Pap test every year. But after three negative Pap tests, women should be screened less often.

2003 -- ACOG guidelines shift from recommending the first Pap smear at age 18 or the onset of intercourse to age 21 or three years after the onset of intercourse.

2008 -- The American College of Obstetricians and Gynecologists guidelines shift to recommend adolescents who have a minor abnormality on a Pap test wait to get biopsies and a diagnostic test called a colposcopy.

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Pap Smear Test guidelines changed: Fewer Pap Tests advised for women in 20's

Washington, D.C.

Most women in their 20s can have a Pap smear every two years instead of annually, say new guidelines that conclude that's enough to detect slow-growing cervical cancer.

The change by the American College of Obstetricians and Gynecologists comes amid a separate debate over when regular mammograms to detect breast cancer should begin. The timing of the Pap guidelines is coincidence, said ACOG, which began reviewing its recommendations in late 2007 and published the update today in the journal Obstetrics & Gynecology.

The guidelines also say:

— Routine Paps should start at age 21. Previously, ACOG had urged a first Pap either within three years of first sexual intercourse or at age 21.

— Women 30 and older should wait three years between Paps once they have had three consecutive clear tests. Other national guidelines have long recommended the three-year interval; ACOG had previously backed a two- to three-year wait.

— Women with HIV, other immune-weakening conditions or previous cervical abnormalities may need more frequent screening.

Paps can spot precancerous changes in the cervix in time to prevent invasive cancer, and widespread use has halved cervical cancer rates in the U.S. in recent decades. About 11,270 new cases will be diagnosed this year, and about 4,070 women will die from it, according to American Cancer Society estimates. Half of women diagnosed with cervical cancer have never had a Pap, and another 10 percent haven't had one in five years.

Cervical cancer is caused by certain strains of the extremely common sexually transmitted virus called HPV, for human papillomavirus. There is a new HPV vaccine that should cut cervical cancer in the future; ACOG's guidelines say for now vaccinated women should follow the same Pap guidelines as the unvaccinated.

But the updated guidelines reflect better understanding of HPV. Infection is high among sexually active teens and young adults. Women's bodies very often fight off an HPV infection on their own without lasting harm, although it can take a year or two. The younger the woman, the more likely that HPV is going to be transient.

Moreover, ACOG cited studies showing no increased risk of cancer developing in women in their 20s if they extended Pap screening from every year to every two years.

As for adolescents, ACOG said cervical cancer in teens is rare — one or two cases per million 15- to 19-year-olds — while HPV-caused cervical abnormalities usually go away on their own, and unnecessary treatment increases the girls' risk of premature labor years later.

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Two drugs present promising new treatment for cervical cancer

Madison, WI

Evista, Faslodex Effective in Animal Studies, Researchers Say
By Kathleen Doheny
WebMD Health News
Reviewed by Louise Chang, MD

Two medications on the market to treat breast cancer and osteoporosis worked well to eliminate cervical cancer in animal studies, according to new research.

The two drugs also kept precancerous growths from becoming cancerous, says researcher Sang-Hyuk Chung, PhD, a research associate at the McArdle Laboratory for Cancer Research at the University of Wisconsin School of Medicine and Public Health in Madison.

"If it's translatable to humans, then it may open up another treatment possibility," Chung tells WebMD. His study is published in PNAS Early Edition.

But experts who reviewed the research for WebMD say it must be viewed as preliminary. Chung agrees, saying, "It will take years to get results from potential clinical trials."

An estimated 11,270 new cases of invasive cervical cancer are expected in the U.S. this year, according to the American Cancer Society; about 4,070 women will die from the disease. Cervical cancer treatment options include surgery, chemotherapy, and radiation, depending on the stage at which it is detected.
Drug Treatment for Cervical Cancer: Study Details

Chung and Paul F. Lambert, PhD, also at the University of Wisconsin, tested the drugs on mice genetically engineered to carry human papillomavirus ( HPV) 16, a strain that is strongly associated with cervical cancer.

In the U.S., genital HPV is the most common sexually transmitted infection, according to the CDC. New HPV vaccines can prevent some infections but can't eliminate infections already present or precancerous growths. There are many different HPV strains.

Although many women become infected with HPV, few develop cervical cancer, as the virus often clears on its own. Since not all HPV-infected women get cervical cancer, Chung and others have long suspected another factor is in play. They decided to focus on estrogen, a hormone to which the cervix and other female organs are responsive.

It's known that long-term use of birth control pills, as well as multiple pregnancies, increase the risk of cervical cancer in HPV-infected women, Chung writes.

In their mouse model, estrogen is required for cervical or vaginal cancer to develop, according to Chung.

So Chung and Lambert gave the mice either Faslodex, used to treat certain breast cancers, or Evista, used to treat osteoporosis and to reduce the risk of breast cancer in some women. One group of animals with cervical cancer was untreated.

The drugs prevent estrogen from working in the cervical cells, according to the researchers.

After a month, the researchers looked at the results. Over 90% of those treated with either Faslodex or Evista did not have cancer, Chung says. The drugs also were effective in eliminating precancerous growths.

"At this point I cannot say whether one [drug] is better than the other," he says.

Chung says the drugs may one day provide another cervical cancer treatment option.

Second Opinion

The real value of the research may prove to be showing experts a more precise model of how cervical cancer develops, says Margaret Madeleine, PhD, an assistant member of the Fred Hutchinson Cancer Research Center and research assistant professor of epidemiology at the University of Washington School of Public Health in Seattle, who reviewed the findings for WebMD.

''There may be more interest in it as a model of how cervical cancer might develop in the presence of birth control pills or [multiple pregnancies], both known risk factors [in HPV-positive women]," she says.

Ernest Han, MD, PhD, gynecologic oncologist and assistant professor at the City of Hope Comprehensive Cancer Center in Duarte, Calif., calls the research finding an interesting concept.

Overall, he says, ''our detection [of cervical cancer] is pretty good.'' Pap tests look for cervical cell changes caused by HPV so the cancer can be detected early. However, "treatment for advanced cancer and for patients who have recurrences is poor," he says.

The study, however, has limitations, Han says. It was small. It would be ''a leap" to say this may soon be a treatment for cervical cancer. ''We'd have to see more definitive studies."

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GlaxoSmithKiline study: HPV-16/18 vaccine is highly effective in preventing precancerous cervical lesions

Helsinki, Finland

Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland

In this article, the author offers a concise, practical summary of the research findings reported in Paavonen J, Naud P, Salmerón J, et al; the HPV PATRICIA study group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009;374(9686):301-314.

Key research findings

● The HPV-16/18 AS04-adjuvanted vaccine is highly efficacious against CIN2+ associated with HPV 16/18 and nonvaccine oncogenic HPV types

● The vaccine shows substantial overall efficacy in cohorts relevant to universal mass vaccination and catch-up programs

● The safety profile of the vaccine is favorable and the vaccine is well tolerated

The final analysis of the Papilloma Trial Against Cancer in Young Adults) study shows that the HPV-16/18 AS04-adjuvanted vaccine (Cervarix, GlaxoSmithKline) has high efficacy against the lesions that can eventually lead to cervical cancer. The vaccine also shows crossprotective efficacy against other oncogenic HPV types closely related to HPV-16/18. Furthermore, the vaccine has demonstrated efficacy in women and girls likely to benefit from universal mass vaccination and catch-up programs. The findings were recently reported in The Lancet.1

Protocol
In the PATRICIA study, females aged 15 to 25 years were randomly assigned to receive the HPV- 16/18 vaccine Cervarix (vaccine) or a hepatitis A vaccine (control). The primary end point was to assess vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Details on the collection of samples and other specifics were previously published.2 Results from 3 cohorts were considered as part of the final analysis. The according-to-protocol for efficacy (ATP-E) cohort included all participants who received 3 vaccine doses (at 0, 1, and 6 months), had normal or low-grade cytology at baseline, complied with the protocol, and were evaluable for the primary end point of CIN2+ (vaccine recipients = 8093, controls = 8069). The total vaccinated cohort (TVC) represented the young sexually active population and included all participants who received at least 1 vaccine dose regardless of their baseline HPV status (vaccine recipients = 9319, controls = 9325). The TVCnaïve cohort represented participants who have not yet had sex and who had no evidence of oncogenic HPV infection at baseline (vaccine recipients = 5822, controls = 5819).

Results
The mean follow-up was slightly less than 3 years after the third dose. In the primary analysis, which considered protection against CIN2+ that was associated with HPV-16/18, vaccine efficacy was 93%. In another analysis, which assigned the cause of lesions infected with multiple oncogenic HPV types (according to a type assignment algorithm) to a single type, vaccine efficacy was 98%. When the HPV type detected in the lesion was not considered in the analysis, vaccine efficacy was 30% in the TVC and 70% in the TVC-naive. Corresponding values against CIN3+ (the immediate precancer of invasive cervical cancer) were 33% and 87% in the TVC and TVC-naïve cohorts, respectively, an indication that HPV-16/18 plays a larger role in CIN3+. CIN3+ is considered to be a more reliable end point than CIN2+. Longer follow-up was required to observe the vaccine's effect on CIN2+ lesions resulting from newly acquired infections because no change in CIN2+ lesions derived from prevalent infections or low-grade lesions would be anticipated with the vaccine. Delayed separation of the Kaplan- Meier curves showing the cumulative incidences of CIN2+ in the study population support this finding.

The vaccine was also shown to be protective against other oncogenic HPV types—most notably HPV-31 (related to HPV-16), HPV-45 (related to HPV-18), and HPV-33. Overall, the vaccine efficacy was calculated at between 37% and 54% against 12 nonvaccine oncogenic HPV types. Worldwide, HPV-16/18 is thought to be responsible for 70% of cervical cancer, while other oncogenic HPV types cause the remaining 30%. The 5 HPV types previously named—HPV-16, 18, 31, 33, and 45—account for approximately 82% of all cases of cervical cancer. Given its cross-protective efficacy, this vaccine could provide protection against cervical cancer that is 11% to 16% greater than that which it provides against HPV-16/18.

Along with the reduced number of lesions, HPV-vaccine recipients in the TVC and TVC-naive cohorts received significantly fewer referrals for colposcopy and underwent significantly fewer cervical excision procedures. In the TVC-naïve cohort, colposcopy referrals were 26% lower and cervical excision procedures were 69% lower than in controls. Fewer cervical excision procedures could lead to a reduction in preterm births and other adverse pregnancy outcomes that have been associated with treatment of CIN.

Discussion
The strengths of the study include its duration; size; and diversity of participants, who came from North America, Latin America, Europe, and Asia-Pacific regions. Continued monitoring through Pap smears and HPV testing in all women, whether vaccinated or unvaccinated, is of vital importance and must be stressed. However, HPV vaccination has the potential to substantially reduce both the incidence of cervical cancer and precancer as well as the numbers of colposcopy referrals and cervical excision procedures. The results observed in the TVCnaive cohort give a good indication of the potential benefit of vaccinating adolescents before they become sexually active—ie, the population being targeted for universal mass vaccination.

The study has some limitations. First, because of the high efficacy of the vaccine against HPV-16/18, a larger number of colposcopy referrals were made in the control group than in the vaccine group. This could have led to detection of more lesions caused by nonvaccine HPV types. Data for persistent infection are not affected by this bias, however, and those results also indicate protection against important nonvaccine oncogenic HPV types. Other study limitations include possible underestimation of the true incidence of CIN2+ lesions from nonvaccine HPV types, since those lesions take longer to develop than lesions caused by HPV-16/18. Caution should be exercised in applying these results to the general population because they are based on completion of the 3-injection series by a high proportion of women (92%), a goal that might not be possible in real life.

In terms of safety, the HPV-16/18 AS04-adjuvanted vaccine and the control vaccine had similar profiles. When data from almost 30 000 girls and women taking part in phase 2 and 3 trials (including ours) were pooled, most recipients tolerated the vaccine well and the safety profile was favorable in participants of all ages.

Currently, the target population for HPV vaccination is girls and young women aged 11 to 26 years prior to their first sexual experience. The most efficient way to stop the virus is to also vaccinate the other half of the sexually active population: boys and men. Studies are now ongoing to develop the best vaccination strategy.

Summary
Our results show that the efficacy of the HPV-16/18 AS04-adjuvanted vaccine is high in protecting women and girls against CIN2+ lesions associated with HPV- 16/18 and nonvaccine oncogenic HPV types. The vaccine also has a substantial overall effect in populations that have been targeted for universal mass vaccination and catch-up programs.

References
1. Paavonen J, Naud P, Salmerón J, et al; the HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009;374(9686):301-314.
2. Paavonen J, Jenkins D, Bosch FX, et al; HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet. 2007;369(9580):2161-2170.

Author disclosure: Funding for the study was provided by GlaxoSmithKline Biologicals. Dr Paavonen has received funding through the University of Helsinki to conduct HPV vaccine studies for Merck and GSK.

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Liquid-Based Cytology Is Not Superior to the Conventional Papanicolau (Pap Smear) Testing

A recent research featured in the October edition of the Journal of the American Medical Association presents a Dutch investigation that studied approximately 90,000 women who underwent the Papanicolau test.

The investigators state that the liquid-based cytology which represents an alternative to the traditional Papanicolau test provides no advantage in comparison with the latter in finding pre-cervical cancer symptoms or the actual disease.

The medical world thought the Papanicolau test to be under the detection standards because it sometimes provided false- positive or negative results for the patients who underwent it. Regarding the usage of body cell entitled liquid-based cytology, the cells coming from the cervix are gathered thorough the use of a common sampling gadget and are put into a vial containing some preservation substance compared to the process of putting the sample on a glass slide, a thing which was used in the past. However, even if this represents a new detection method, various researches showed that the accuracy of the detection was not always a certain fact.

The team of scientists undergoing the investigation was led by Albertus Siebers from the Radboud University Nijmegen Medical Centre located in the Netherlands state Nijmegen. He and his colleagues started the research by comparing the screening accuracy of the Papanicolau tests and the liquid-based cytology. They looked at the positive results rate, the histological detection ones and the PPVs (positive predictive values). The investigation had a random character and comprised a number of 89,784 females who aged between 30 years and 60 years. All of the women were included in a screening process for cervical cancer which comprised 246 family Dutch clinics. From these family practices, 122 used liquid-based cytology and verified 49,222 women and the rest of the medical facilities used the traditional Papanicolau testing and verified 40,562 women. The females were controlled for CIN (cervical intraepithelial neoplasia) and were monitored for eighteen months until January. This took place in the year 2008.

The group of investigators discovered that the adjusted detection rate for cervical intraepithelial neoplasia garde 1+ was of 1.01, for the cervical intraepithelial neoplasia grade 2+ it was 1, for cervical intraepithelial neoplasia grade 3+ it was 1.05 and for carcinoma, the ratio was 1.69. As the investigators explain, this adjusted ratio did not vary very much from one for certain results of cervical intraepithelial neoplasia in the cases of some cytological call-off.

Due to the random character of the investigation, it can be thought that the propensity of cervical intraepithelial neoplasia was the same for both of the tested samples. This is why the inexistence of variation in the detection ratios and the positive predictive values during the specific research proved that the liquid-based cytology is not more sensitive or more accurate in discovering the cancer affecting the cervix compared to the traditional Papanicolau method.

The scientists concluded that there was not a significant variation in the positive rates provided by the cytological testing mechanisms. However, the evidence provided by this innovative detection process does not bring enough proves to state a similar accuracy in diagnosing women who suffer from cervical cancer. The analysis comprising the intent to treat and the way in which doctors can do this showed that the liquid-based cytology was not better than the Papanicolau test in the matter of finding positive rates of the already studied under the microscope results.

The same outcome came from the positive predictive values. In conclusion, the evidence provided by the investigation states that if the cytological testing is done in a very organized and qualitative screening for cervical cancer process, it does not differ from the traditional Papanicolau test.

Mark Schiffman and Diane Solomon, both medical doctors from the National Cancer Institute state their opinion regarding this research. Nowadays, being a doctor involved in the prevention of the cervical cancer seems to be a very challenging position. Even if the methods and tools used in the cervical detection process are updated and come in high numbers, no corroboration of vaccines, humanpapilloma virus tests, cytology, colposcopy and innovative ways would apply in the same way for all the women. They state that if we deal with areas around the Globe in which the health rates and quality of life are very high, the vaccines, liquid-based cytology or humanpapilloma virus tests could be a waste of resources if they are not taken out in a planned manner.

In addition, the medical doctors believe that the research undergone by Siebers team has made things simpler in the means that those persons involved in cervical cancer screening, monitoring and treating can use one of the two detection methods: the traditional Papanicolau test or the liquid-based cytology. Even if this decision-making process became more complex at the moment when the cytology appeared on the health market, the investigators managed to make the doctors see the exact role of this new detection method in applying treatments to their patients.

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Cervical cancer vaccination rate for teeneage girls is 1 in 3, says CDC

Atlanta, GA

ne in three teenage girls have rolled up their sleeves for a vaccine against cervical cancer, but vaccination rates vary dramatically between states, according to a federal report released Thursday.

The highest rates were in Rhode Island, New Hampshire and Massachusetts, where more than half of girls ages 13 through 17 got at least one dose of the three-shot vaccination. The lowest rates were in Mississippi, Georgia and South Carolina, where fewer than 20 percent got at least one shot.

The report is the first to give state-by-state rates for Merck's Gardasil vaccine. It targets strains of the sexually transmitted human papillomavirus that cause about 70 percent of cervical cancers. It came on the market in 2006.

Health officials recommend that girls get the shots when they are 11 or 12, if possible, before they become sexually active so they have immunity before they are first infected. The shots are approved for females 9 through 26.

The Centers for Disease Control and Prevention study involved a 2008 telephone survey of the parents of nearly 18,000 adolescents, who allowed researchers to check their kids' vaccination records.

Nationally, there was an increase in the percentage of teens ages 13 to 17 vaccinated against meningitis, tetanus, diphtheria and other illnesses. The agency also noted a rise since 2007 in the percentage of teenage girls who had gotten at least the first dose in the three-shot vaccination series against cervical cancer.

In 2007, about 25 percent had gotten a first dose of the vaccine. Last year, it rose to about 37 percent.

CDC study also found that the number of girls who got the whole three-dose series was only 18 percent and the rate was higher for white girls than for blacks or Hispanics.

Vaccine proponents had been hoping for higher vaccination rates, saying the shots could dramatically reduce the nearly 4,000 cervical cancer deaths that occur each year in the United States.

It's not clear why state vaccination rates vary so much, but several factors could be involved, said Dr. Melinda Wharton, an administrator of the CDC center that did the research.

Money is an issue. Retailing at $390 for the three-dose series, Gardasil is the most expensive childhood vaccine.

Many health insurers pay for the shots, but health officials noted variations in public insurance coverage. A federal program pays for certain children, including those who are uninsured or are in state Medicaid programs, but some states were slower to take advantage of it than others.

Also, it takes three trips to the doctor over six months to get all the shots, and some parents are unable or unwilling to take their kids to the doctor that often.

In South Carolina, many parents have said they are concerned about the safety of the vaccine or that they don't understand why a girl should get vaccinated before she's sexually active, said Heather Brandt, a University of South Carolina public health researcher.

"It's disturbing to see those states at the lower end of participation," she added. "Because those are states with some of the highest rates of cervical cancer."

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FDA panel backs Glaxo's Cervarix cervical cancer vaccine

Gaithersburg, MD

GlaxoSmithKline PLC's proposed cervical cancer vaccine is safe and effective for girls and young women ages 10 to 25, a U.S. advisory panel said on Wednesday.

The endorsement from Food and Drug Administration advisers moves the Cervarix vaccine closer to the U.S. market to compete with Merck & Co's Gardasil shot.

The panel will vote later Wednesday on whether Merck should be allowed to widen its potential market by promoting Gardasil for men and boys as young as 9 for prevention of genital warts.

Both vaccines are designed to protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.

"The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health, adding "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological harm.

The committee voted 12-1 that Cervarix was effective.

The FDA usually follows panel recommendations. Glaxo said a final decision on Cervarix may come as early as this month.

The vaccine already is approved in 98 countries, but some analysts say it will be hard for Glaxo to compete against Gardasil's three-year headstart in the U.S. market. Gardasil won FDA clearance in 2006, while Cervarix stalled following Glaxo's initial application in 2007.

The delays mean Cervarix is no longer the mega blockbuster hope it once was, although FDA approval could still be a minor positive catalyst for Glaxo shares, Citigroup analysts said.

Four years ago, previous chief executive Jean-Pierre Garnier touted the vaccine as Glaxo's most important new product. But the British drugmaker missed the opportunity to vaccinate the initial group of eligible teenage girls in the United States, ceding that business to Gardasil.

Consensus forecasts ahead of the panel decision suggest Cervarix will generate worldwide sales of about $1.2 billion in 2013, equivalent to some 2.5 percent of expected Glaxo sales for that year, according to Thomson Reuters I/B/E/S.

Cervical cancer is often caught early in the United States through Pap smears while the disease is treatable. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.

"If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year," said Barbara Howe, director of Glaxo's North American vaccine development.

The company promised to track potential complications and miscarriages after approval. Neither Cervarix nor Gardasil is recommended for pregnant women.

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The cervical cancer vaccine question: Gardasil for my daughter?

St. Petersburg, FL

When Raffi Darrow brought in her two daughters, Wendy and Alice, for their annual back-to-school checkups this week, for the first time in her career as a mom, Darrow decided to be a rebel.
Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Even though every federal health authority says her girls, ages 11 and 12, should get Gardasil, the vaccine that helps protect against cervical cancer and genital warts caused by the human papillomavirus, Darrow instructed the pediatrician not to give it to them.

"Up until now my children have had every vaccine doctors have recommended," says Darrow, a graphic designer in St. Petersburg, Florida. "But most friends, like me, fear the safety of something new."

Even though Gardasil is on the Centers for Disease Control and Prevention's vaccine schedule for 11- and 12-year-old girls, and is recommended by the American Academy of Pediatrics, many parents interviewed by CNN say they're not getting it right now for their daughters out of concern for side effects.

"I'm not saying I'll never do it. I just don't want to do it when they're 11 or 12," says Darrow, who debated for a year about whether to get the shots for her daughters.

Liz Schlegel, on the other hand, didn't hesitate to get Gardasil for her 15-year-old daughter. "My older sister was diagnosed with (and beat!) cervical cancer two years ago, and her doctors traced it to HPV," says the manager of a small design firm from Waterbury, Vermont. "I would hate to think that normal sexual experimentation -- the kind that my sister and I and many of our friends and peers "tried on" in college -- could result in a life-threatening illness 30 years later."

A survey of 1,122 physicians in Texas showed that about half don't always recommend Gardasil to parents of 11- and 12-year-old girls, even though the CDC recommends it. The survey was published earlier this month in Cancer Epidemiology Biomarkers & Prevention, a journal of the American Association for Cancer Research.

In an unscientific QuickVote poll, respondents were split on whether they'd get the vaccine for their daughters, with 43 percent saying absolutely they would, 40 percent saying no way, and the rest saying they weren't sure. As of Wednesday, more than 5,000 people participated in the informal survey. To cast your vote go to CNNhealth.com.

Unlike most other vaccinations, Gardasil is not required for a child to attend school. As of 2007, the latest year for which statistics are available, 25 percent of 13- to 17-year-olds had received a dose of Gardasil, according to the CDC. Read what parents and pediatricians have to say about Gardasil »
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"Although the numbers are low, we are optimistic this percentage will increase over time," says Arleen Porcell-Pharr, a spokeswoman for the federal agency. "We would like to see 100 percent adherence to the CDC schedule, [but] from previous experience, we know that it takes years for a new vaccine to gain acceptance into the market."

Darrow and other parents say they're worried about neurological problems, blood clots and deaths that have been reported to the CDC after a woman or girl has been vaccinated with Gardasil. The vaccine is given in a series of three injections. Read a discussion on TwitterMoms about Gardasil

According to the Vaccine Adverse Event Reporting System run by the CDC and the Food and Drug Administration, as of May 1, there were 13,758 reports of adverse events occurring after women and girls received Gardasil, out of the more than 24 million doses that had been given to girls and women up until that time. On its Web site, the CDC notes that these events "may or may not have been caused by the vaccine."

Most of the problems -- 93 percent -- were considered to be mild, such as headache, nausea and fever. But 7 percent involved a hospitalization, permanent disability, life-threatening illness or death.

In the data, 39 deaths were reported after vaccination with Gardasil, with 26 confirmed by the agency, six under investigation, and seven unconfirmed. "There was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine," according to the CDC's Web site.

Gardasil, which prevents four types of human papillomavirus that cause 70 percent of all cervical cancers and more than 90 percent of genital warts, was heralded as a breakthrough when it was introduced more than three years ago by the pharmaceutical company Merck.

Since the reports, Merck has added several adverse reactions to the labeling, stating that some people after receiving Gardasil have developed autoimmune diseases, musculoskeletal disorders, paralysis and seizures.

"It's not possible to reliably estimate the frequency [of these adverse events] or to establish a causal relationship to vaccine exposure," the label states.

Dr. Rick Haupt, the pediatrician who leads Merck's research on Gardasil, says the vaccine is safe and effective for 11- and 12-year-old girls. "We have good evidence that the vaccine is appropriate to use at this age," he says.

He added that many countries, including the United States, recommend the shot at age 11 or 12 in hopes of getting girls vaccinated before they become sexually active, because HPV is transmitted sexually. Also, he says it's beneficial to vaccinate children this age because their "immune response is very robust."

Doctors and Gardasil

When her children were younger, Darrow's pediatrician urged her to get all the vaccines on the CDC schedule. She noticed, however, that when she told the pediatrician she didn't want Gardasil for Wendy and Alice, the doctor didn't push her to reconsider.

"There was no argument, no trying to persuade me, no 'Here's a pamphlet about Gardasil,' nothing," Darrow says.

Several pediatricians interviewed by CNN said they don't push the HPV vaccine if parents don't want it.

"I consider this to be an optional vaccine," says Dr. Arthur Lavin, associate clinical professor of pediatrics at Case Western Reserve University School of Medicine. "I tell parents it's fine with me if you wait, and it's also fine with me if you want that extra added level of protection and we proceed today."

He said about 15 percent of his patients are getting Gardasil for their 11- and 12-year-old girls.
Health Library

* MayoClinic.com: HPV infection
* MayoClinic.com: Cervical cancer
* MayoClinic.com: Cervical cancer vaccine: Who needs it, how it works

Parents researching on the Internet

Before her daughters' checkups this week, Darrow spent several hours doing research on the Internet in order to make her decision about Gardasil.

She said what tipped the scales for her were statements made in the media by Dr. Diane Harper, an obstetrician and gynecologist at the University of Missouri who helped Merck do clinical trials on Gardasil, at one point serving on the company's advisory board for the vaccine.

Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

"Gardasil is not without risks. It's not a freebie," Harper says.

Harper says she worries that not enough young girls were included in Merck's clinical trials to warrant giving the shot to all young girls.

Merck has given the vaccine to 1,121 girls between 9 and 15 years old in clinical trials without serious side effects, according to Haupt, the Merck pediatrician. He says the company will try to continue to follow these girls for 10 years.

In addition to safety concerns, Harper said she wonders whether the vaccine will still be effective for an 11- or 12-year-old after she's become sexually active.

Gardasil is "100 percent" effective against HPV five years after vaccination, according to Haupt, and Merck is studying whether its efficacy lasts longer than that.

Darrow says this is one reason she decided not to get the shots for Wendy and Alice. "Even if the shot lasts for 10 years, it would run out just when they're at their riskiest time," she says. "If I give it to my 11 year old right now, she'd need a booster at age 21."
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She added that she hasn't rejected the idea of getting Gardasil for her daughters, considering that it would give them some protection against cervical cancer.

"I'm going to revisit this again when they're 14 or 15," she said.

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New report shows Tennessee's policies to prevent cervical cancer are falling short

Chattanooga, TN

According to a new report, Tennessee is falling short in its legislative efforts to combat cancer. How Do You Measure Up?: A Progress Report on State Legislative Activity to Reduce Cancer Incidence and Mortality evaluates each state’s legislative activity on six issues key to winning the fight against cancer. Developed by the American Cancer Society Cancer Action Network (ACS CAN), the advocacy affiliate of the American Cancer Society, the report finds that Tennessee met none of the benchmarks set for six issues.

“Our state legislators can play an important role in the war against cancer by passing legislation that can help reduce the toll this disease takes on our state and save lives,” said Bill Evans, an ACS CAN volunteer. “We all have a responsibility to fight back against a disease that kills 13,340 in Tennessee each year by enacting laws and policies that eliminate barriers for the proper diagnosis, treatment and care of cancer patients.”

How Do You Measure Up? details state efforts around health care coverage, prevention and quality of life measures. The report measures state policies (as a result of a legislative vote or a ballot initiative) on six specific issues: breast and cervical cancer early detection program funding; access to care for the uninsured; colorectal screening coverage laws; smoke-free laws; pain management; and tobacco taxes. A color-coded system is used to identify how well a state is doing. Green represents the benchmark position with well-balanced policies and good practices; yellow indicates moderate movement toward the benchmark and red shows where states are falling short.

In addition to the specific areas that were rated, the report also examines how states are measuring up on issues such as the affordability of health coverage on the individual market or through Medicaid for low-income populations. It also details state efforts to fund tobacco prevention and cessation programs and as well as state investments in nutrition and physical activity promotion.

“As advocates, we have the responsibility to educate the public on the many ways to prevent and fight cancer effectively at the state level, but we cannot do it unless state and local policymakers take action,” said Mr. Evans. “In most cases, the solutions we offer will save the state millions of dollars in health care costs and increased worker productivity. In many cases, it costs the state little or nothing to do the right thing.”

This past legislative session, volunteer advocates worked to pass comprehensive colorectal cancer screening legislation that would have created the framework for a screening program for the underserved and would have required insurance companies to cover colorectal cancer screenings. However, the proposed legislation got rolled over to the second half of the legislative session, which begins in January 2010.

How Tennessee measures up:
Breast and Cervical Cancer Early Detection Program Funding: Yellow

The Uninsured: Red

Colorectal Screening Coverage Laws: Red

Smoke-free Laws: Red

Pain Management: Red

Tobacco Taxes: Red

Throughout the past year, state legislatures across the country have made great advances in the fight against cancer. In the last year, 12 states and the District of Columbia have passed or implemented tobacco tax increases, bringing to 46 the total number of states with tobacco tax increases since 2002. Six more states implemented comprehensive smoke-free laws, protecting workers and patrons from the hazards of secondhand smoke. And many states are working on policies and programs to reduce cancer risk related to poor nutrition, lack of physical activity and obesity.

In addition, many state legislatures fought hard to preserve coverage for lifesaving cancer screenings and treatments and to stave off attempts to cut state funds that support these programs, such as the National Breast and Cervical Cancer Early Detection Program.

In 2009, more than 1.4 million people in the United States will be diagnosed with cancer and more than 562,000 people will die from the disease. In Tennessee this year, 32,570 people will be diagnosed with cancer and another 13,340 will die of the disease.

For state-by-state details or a copy of the complete report, please visit www.acscan.org.

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Pap Test screening shown to lower incidence of adenocarcinoma of the cervix

New York, NY

Contrary to common opinion, routine cervical screening can identify early-stage adenocarcinoma and adenosquamous carcinoma of the cervix, according to a large case-control study that used routine records of cervical cytology from UK databases.

"Although there can be no doubt about its effectiveness in preventing squamous cell carcinoma, there is little evidence of any benefit on adenocarcinoma and adenosquamous carcinoma of the cervix, and many authors have concluded that it is ineffective," Dr. Peter Sasieni and co-investigators point out in the International Journal of Cancer for August 1.

They evaluated screening histories for 3305 women, ages 20 to 69 years, with invasive cervical cancer diagnosed since 1990. The cancers included adenocarcinomas (19%), adenosquamous carcinomas (4%), and squamous carcinomas (77%).

For each subject, Dr. Sasieni, at the Wolfson Institute of Preventive Medicine in London, and co-researchers chose an age-matched control from the same group practice, and another from a different practice in the same area. They used these data to estimate the magnitude and duration of the low-risk period following a negative smear, and the degree of protection associated with routine screening.

The odds ratio of developing a stage 1B tumor or worse within 2.5 years of an invasive cervical cancer was 0.23 for adenocarcinoma, 0.09 for squamous carcinoma, and 0.10 for adenosquamous carcinoma. The differences between 2.5 and 3.5 years after a negative smear were even larger, with odds ratios of 0.67 for adenocarcinoma, 0.15 for squamous carcinoma, and 0.20 for adenosquamous tumors.

"It is no surprise that screening is less protective against adenocarcinoma of the cervix," Dr. Sasieni's team points out. "These can occur in the endocervical canal and are less amenable to detection at an early stage by exfoliation cytology."

Still, the researchers maintain that screening has a significant impact on the incidence of adenocarcinoma. They estimate that such tumors can be detected, but it may be harder to do so, and requires a shorter lead time than for squamous cell carcinoma.

By contrast, the impact of screening on adenosquamous carcinoma was nearly the same as the impact on squamous carcinoma. The authors theorize that this similarity between the two types "represents phenotypic drift of lesions that evolve from CIN and only later acquire glandular involvement."

Source:Int J Cancer 2009;125:525-529.

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Glaxo study shows Cervarix fights protects against the five most common cervical cancer-causing viruses

London, UK

GlaxoSmithKline Plc's (GSK.L) 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.

It is the first time for any cervical cancer vaccine that significant protection has been shown against pre-cancerous lesions not containing the two most common virus types, Glaxo said in a statement.

"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.

BOYS AND MEN

Cervarix and its rival Gardasil, produced by Merck & Co Inc's (MRK.N), are only approved for use in girls and women, but the companies are seeking new markets and some experts say it should be used in boys and men, to protect them and their future sexual partners.

In comments accompanying the Cervarix study, the researchers said the only efficient way to stop the virus is to also vaccinate boys and men because they make up the other half of the sexually active population.

"Women have shouldered responsibility for contraception since its inception. The goal to eradicate sexually transmitted carcinogenic viruses can be jointly carried by women and men and could be accomplished within a few decades," said Karin Michels from the Harvard Medical School in Boston and Harald zur Hausen from the German Cancer Research Centre in Heidelberg.

Glaxo is waiting for approval in the U.S. market for Cervarix. U.S. approval was delayed in June last year after Glaxo said it would augment its application with results from a further study after responding to outstanding questions over the product from the Food and Drug Administration.

Cervarix is already approved in more than 90 countries including major European markets. (Reporting by Ben Deighton; Editing by David Holmes and Jon Loades-Carter)

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National Cancer Insitutue: Treatment regimen extends survival for women with cervical cancer

Bethesda, MD

Making the chemotherapy drug gemcitabine part of the initial treatment of locally advanced cervical cancer and also part of therapy following primary treatment significantly improved survival for women with locally advanced cervical cancer, according to the results of an international, phase III clinical trial.

Presented recently at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, the results have important implications for the treatment of women with cervical cancer in developing countries, where 70 to 80 percent of women are diagnosed at a locally advanced stage due to a lack of widespread screening programs, said lead investigator Dr. Alfonso Dueñas-González of the National Cancer Institute of Mexico.

More than 500 women with stage IIB to stage IVA cervical cancer—from countries as disparate as Pakistan and Panama—participated in the trial. They were randomly assigned to the experimental treatment arm, which included cisplatin and gemcitabine with concurrent external-beam radiation therapy, followed by brachytherapy and adjuvant chemotherapy with gemcitabine and cisplatin. Women in the standard treatment group received cisplatin and concurrent external-beam radiation therapy followed only by brachytherapy.

Approximately 75 percent of women who received the experimental treatment did not experience progression of their disease 3 years after treatment, compared with 65 percent of women who received standard treatment. Overall survival was improved by more than 40 percent, the researchers reported. The research team had expected more toxicity with the addition of gemcitabine, and that is what they saw.

"Overall, the frequency of grade III and IV toxicities was higher in the experimental arm, mainly hematological toxicity," Dr. Dueñas-González said. Grade IV toxicities were low overall, he added, and generally toxicities in the experimental arm were "tolerable and manageable."

The trial "in all likelihood defines a new standard of care" for patients with locally advanced cervical cancer, said Dr. Eric Winer, chief of the Division of Women's Cancers at Dana-Farber Cancer Institute.
Standard Treatment for Anal Cancer Confirmed

The largest clinical study of patients with anal cancer has found that the current standard treatment should not be changed. In addition, patients in the study did not benefit from maintenance chemotherapy that was designed to prevent a recurrence, according to the ACT II study, a phase III, randomized trial involving 940 patients.

Most of the 5,000 patients diagnosed with anal cancer in the United States each year have the squamous cell type, which often responds to radiation therapy and chemotherapy. For a decade, the treatment for anal cancer has been radiation plus 5-fluorouracil (5-FU) and mitomycin-C chemotherapy. In this trial, British researchers asked whether replacing mitomycin-C with cisplatin could improve results for patients, but the answer was no. Furthermore, patients did not benefit from maintenance chemotherapy with cisplatin and 5-FU.

Overall, however, the patients had very good results relative to the international trials published to date, noted Dr. Roger James of the Maidstone Hospital in Kent, who presented the findings at the recent ASCO annual meeting. At 6 months, 95 percent of patients in both groups had all signs of cancer disappear, and at 3 years, nearly 85 percent of the patients in the trial were alive.

Cisplatin was evaluated because it is commonly used to treat other squamous cell cancers, the researchers said, noting that it is not as convenient to deliver and has different toxicities than mitomycin-C chemotherapy. Future trials will likely ask whether certain patients might benefit from other forms of maintenance therapy.

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Green tea studied in search to stop cervical cancer

Tuscon, AZ

The group of viruses known as HPV is a known cause of cervical cancer. It’s also the most common sexually transmitted disease in the United States. It’s estimated that half of all sexually active Americans will contract HPV during their lifetime and at any given time approximately 20,000,000 people in the United States are carrying the disease.

Most people who get HPV clear the infection on their own, but some people have persistent HPV which can lead to precancerous lesions and other damage to a woman’s cervix. Although the Food and Drug administration approved Gardasil, a vaccine for the virus, in 2006, it cannot be given to women who have already been infected, even if the disease in no longer present in their bodies.

Up until now, all known treatment for persistent HPV have been painful and invasive, involving freezing or surgical removal of part of the woman’s cervix. Both procedures also make it difficult for a pregnant woman to carry a baby to full term. This has lead scientists to search for a better, less invasive method of stopping HPV before it causes the precancerous lesions.

Now Arizona Cancer Center is testing a green tea extract known as Polyphenon E, to see if it is effective against HPV. The $1 million clinical trial will include 150 women in Arizona, California, and North Carolina, all of whom currently are currently infected with HPV. Half of the women will be given a placebo. The other have will be given 800-milligram capsules of green tea extract. This is about the same amount of green tea flavonoids one would receive from drinking approximately 8 cups a day of green tea.

According to Wendy Thomas, research specialist at the Arizona Cancer Center, which is affiliated with the University of Arizona, “Finally we will have a yes or a no. And it may not work, but at least we will know."

The study is being funded by National Cancer Institute’s Division of Cancer Prevention.

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Cervical cancer- shame and fear?

Seattle, WA

Thanks to the new HPV commercials the general public is now aware that cervical cancer can be caused by an STD. They urge more people to be tested and vaccinated, yet now that it has been added to the ‘dirty disease’ category like HIV and AIDS will less women be tested or comfortably admit their diagnosis? It’s sad that we live in a judgmental world. Cancer is cancer no matter where it is on your body. Breast cancer carried the same hush-hush stigma not so long ago and more women lost their lives going undiagnosed or diagnosed too late.

Not all patients with cervical cancer had HPV. In the words of a 33 year old woman who underwent a radical hysterectomy to save her life, “I have no family history of cervical cancer; I’ve never had any STDs; I haven’t had multiple sex partners; and I don’t HPV. Perhaps, when people are aware that one has cervical cancer, they won't look at it as being a "dirty woman" disease like my family did.”

No one deserves cancer. No one battling cancer deserves to be treated with anything but love and compassion. Remember, any STD can occur with just one time, just one partner. Yes, the risk increases with more partners but the reality of infidelity, or an unknowing infected partner can lead to HPV.

The Seattle Cancer Care Alliance advises, “Regular Pap tests are important to your survival: about 90 percent of women whose cervical cancer was detected by a Pap test will survive. The figure is much lower--only 40 percent--for women whose cancer was not diagnosed until they experienced vaginal bleeding.”

According to the American Society of Clinical Oncology, possible symptoms are:

• Blood spots or light bleeding between or following periods


• * Menstrual bleeding that is longer and heavier than usual


• * Bleeding after intercourse, douching, or a pelvic examination


• * Pain during sexual intercourse


• * Bleeding after menopause


• * Increased vaginal discharge

Be informed, be supportive and never live in fear or shame when your life or their's is on the line.

Find a Gynecologic Oncologist: http://www.wcn.org/findadoctor/ Gynecologic oncologists are specially trained to care for women with gynecologic cancers such as cervical cancer, endometrial, or uterine cancer, or ovarian cancer.

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