CERVICAL CANCER

New cervical cancer test beats pap smear (Yahoo News-09/09/2008)

A new way to test for cervical cancer is more accurate than a pap smear and identified more dangerous lesions, an Italian study showed on Tuesday. Researchers used the traditional test for the human papilloma virus that causes cervical cancer and combined it with another that indicated specific cancer-causing activity in cells, said Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, who led the study. A simple test for a protein called P16INK4A provided a biomarker showing cell changes that indicated a woman likely has pre-cancerous lesions, Ronco and colleagues reported in the journal Lancet Oncology. "The marker shows there was some sort of disruption by the HPV virus," Ronco said. "Only a small minority of women who have an HPV infection actually develop cancer. The challenge is to find out who are at higher risk of developing cancer." Cervical cancer is the second most common type of cancer in women. Each year an estimated 500,000 women are diagnosed with the disease and about 300,000 die from it, mostly in the developing world. Merck & Co's Gardasil and GlaxoSmithKline's Cervarix are vaccines that protect against some strains of the virus. More countries are also adopting screening tests, but the problem is pap smears produce too many false positives -- meaning women get a test that suggests they have potentially cancerous or pre-cancerous changes when in fact they do not. An HPV test looks for the virus while in a pap smear doctors scrape cells from the cervix and examine them under a microscope for abnormalities that could indicate precancerous lesions.

"Most HPV infections simply regress without causing disease," Ronco said in a telephone interview. "They disappear spontaneously, which is the reason there are so many false positives." The Italian team collected cervical cell samples from women who had already tested positive for the HPV virus, most of whom had already undergone an expensive colposcopy exam -- a close examination of the cervix using a magnifying instrument. Then they tested for P16INK4A protein in more than 1,100 of these women and found that it helped identified 88 percent of those who had the cancer-causing lesions with far fewer false positives. The protein is more active in cervical-cancer cells. The refined test also identified 50 percent more of the dangerous lesions than pap smears and required fewer women to be referred for colposcopy, Ronco said.

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FDA approves expanded uses for Gardasil for vaginal and vulvar cancer caused by HPV (Yahoo News-14/09/2008) 

The U.S. Food and Drug Administration has announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. 
These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. "There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV." The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11. HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.

For most women, the body's own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer. Regarding the prevention of vulvar and vaginal cancer, Gardasil's manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study-the other half did not receive Gardasil and served as a control group. Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18. There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil's full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine. 

Gardasil's label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine. No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops. Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization. As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil's approved uses.

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Cervical cancer shots less cost-effective with age (Yahoo News-20/08/2008)

An expensive vaccine aimed at preventing cervical cancer makes sense for young teens when it comes to cost-effectiveness, but not for women in their 20s, contends a new report. The vaccine against the HPV virus was licensed in 2006 for use in girls and women ages 9 to 26. Health officials recommend it for girls at age 11 or 12, and some doctors offer it to women in their 20s in "catch-up" vaccination campaigns. The maker of the Gardasil vaccine, Merck & Co., also wants to market it to women ages 27 to 45, but so far the U.S. Food and Drug Administration has denied that request. The government-funded study found the HPV vaccine is very cost-effective when given to girls at age 12, but raises questions about the value of pushing for vaccinating adults. Two researchers at the Harvard School of Public Health did the study, one of the most sophisticated analyses of the issue so far. Results are in Thursday's New England Journal of Medicine. Gardasil is given in three doses over six months and costs about $375. It targets the two types of HPV, or human papillomavirus, believed to be responsible for about 70 percent of cervical cancer cases, and two other types that cause most genital warts. The virus spreads through sex. Health officials say it's best to give the shots to girls at age 11 or 12, before they begin having sex. Some parents think that age is too young for a vaccination campaign against a sexually transmitted disease.

But that is when the shots make the most economic sense, the researchers found. They used computer models to predict the health outcomes of girls and women who get the vaccination as well as Pap tests or other screenings, which are still recommended for vaccine recipients. Their calculation included the cost of the vaccine, screenings and treating cervical cancer and other illnesses targeted by the vaccine. To determine cost-effectiveness, the researchers used widely accepted economic measures of how much society is willing to pay to extend the life of a person by a year. They set a figure of $43,600 per year for the Gardasil vaccination of each 12-year-old girl, well below the $100,000 mark seen as an upper range for cost-effectiveness. That assumes the vaccine gives lifetime protection — something doctors don't know is true, because the shot is too new. "Their base-case assumptions are quite optimistic," wrote Dr. Charlotte Haug, a Norwegian physician, in an editorial that accompanies the study. The figure would rise if a booster shot is needed, but would still be under the cost-effective threshold, experts said. Another caveat: Costs could rise if there is an increase in the types of cancer-causing HPV not included in the vaccine. Vaccinating "catch-up" campaigns for women in their 20's, however, would not be cost-effective, the researchers said. They didn't calculate cost-effectiveness of vaccinating women ages 27 to 45, but a trend seems clear, said Jane Kim, the study's lead author.

"As you get older, the vaccine becomes less cost-effective," she said. Experts believe that the earlier a female is vaccinated, the better the odds she will avoid HPV-caused cervical disease, thus lowering health-care costs down the road. Even though Merck can't promote its use for them, women older than 26 can get the shot from their doctors, as part of an "off-label" use. An individual woman may decide that getting vaccinated is worth it even if vaccinating everyone her age isn't considered cost-effective, some policy experts noted. Many women in their 30s and 40s have not been exposed to the HPV types in the vaccine and could benefit from the shots, said Dr. Richard Haupt, Merck's executive director for Gardasil research. GlaxoSmithKline PLC has developed another HPV vaccine, called Cervarix, which it sells in other countries. That vaccine has not yet been approved for the U.S. market. 

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HPV & Cervical Cancer Educational Pack Launched (Yahoo News-24/08/2008)

The Royal Society of Health (RSH) is delighted to announce the launch of the HPV & Cervical Cancer: What you & your pupils need to know a FREE curriculum linked teaching & learning resource, with nearly 11,000 copies being distributed across the UK. Professor Richard Parish RSH Chief Executive said: "Education is at the heart of successful interventions to improve the public's health. This new resource aims to raise awareness and understanding of HPV and cervical cancer within a broader sexual health context and empower young people to take informed action to protect their health." "The thirst for information is overwhelming. Over 50 000 copies of the Society's general information leaflet have been requested and it is predicted nearly half of all secondary schools across the UK will be directly reached by the teaching & learning resource." A reception to mark the launch of the teaching and learning resource will be held on 20th August at The Royal Institute of Public Health, with guest speaker Sandra Gidley MP, Liberal Democrat Shadow Health Spokesperson. Professor Parish continues: "Immunisation and vaccination provide an essential tool in improving public health and the introduction of the HPV vaccination programme is a hugely significant step. However, success requires an investment not just in vaccine delivery, but also in the health promotion measures necessary to create a supportive educational and organizational environment. Education is not an 'add-on', but a pre-requisite." 

The Royal Society of Health, a major public health body, has brought together education and heath professionals and young people as an independent steering group, with an educational grant from Sanofi Pasteur MSD, to develop this resource. Sir Ronald De Witt, Chair of the RSH HPV education programme steering group said: "This is an excellent example of collaboration between a charity and the private sector which has very much been in the public interest. We have also ensured close consultation with the public sector. All in all this is a high quality resource to meet a high public demand for information." HPV & Cervical Cancer teaching and learning resource and the HPV & Cervical Cancer: The Basics leaflet are available for download at http://www.rsph.org/policy/HPV/HPV_default.asp The resource pack includes a comprehensive teacher's guide and four complete lesson plans together with supporting source material and IWB Power Point presentations for use in the context of personal, social and health education, sex and relationship education and the science curriculum. 

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Cervical Cancer Prevention In U.S. Should Focus On Vaccinating Adolescent Girls And Revising Screening Policies (Yahoo News-24/08/2008) 

The cost-effectiveness of vaccination in the United States against human papillomavirus (HPV), a sexually-transmitted virus that causes cervical cancer, will be optimized by achieving universal vaccine coverage in young adolescent girls, by targeting initial "catch-up" efforts to vaccinate women younger than 21 years of age, and by revising current screening policies, according to an analysis by Harvard School of Public Health (HSPH) researchers in the August 21, 2008 issue of The New England Journal of Medicine. In the U.S. in 2007, cervical cancer developed in more than 11,000 women and killed 3,600 women. Cervical cancer is caused by infection with high-risk "oncogenic" types of HPV, also associated with other cancers. Worldwide, HPV types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancer cases. Vaccines against HPV-16 and HPV-18 appear to be highly efficacious in preventing HPV-16 and HPV-18 infections and cervical disease in females who have not previously been infected with these types. The quadrivalent vaccine currently licensed in the U.S. also prevents low risk HPV types 6 and 11 (HPV-6 and HPV-11) infections, which are responsible for most genital warts and juvenile-onset recurrent respiratory papillomatosis (JORRP), a rare but severe respiratory condition usually diagnosed in infancy that may be related to a mother's infection with genital warts. Cervical cancer prevention in the U.S. has traditionally relied on a screening program involving frequent cytology (Pap smear) and/or HPV DNA testing, recommended annually or biennially for sexually-active women. HPV vaccination raises questions regarding the age at which to vaccinate females, target groups for temporary catch-up programs, and appropriate changes to screening practices. 

Jane Kim, assistant professor of health decision science in the Department of Health Policy and Management at HSPH, led the study which involved synthesizing epidemiologic, clinical, and demographic information using sophisticated computer models that simulate the U.S. population. The models were used to predict the health and economic outcomes of HPV vaccination of preadolescent girls (i.e., 12 years of age) and catch-up vaccination over a 5-year period for girls and women over 12 years of age, in the context of routine cervical cancer screening; strategies differed in the upper age of catch-up programs, to ages 18, 21, or 26 years. While the study focused on the prevention of cervical disease, the investigators also examined the benefits of the quadrivalent vaccine on genital warts and possible benefits of averting other HPV-related cancers and JORRP. A novel part of this study involved examining how uncertain scenarios might impact the appropriate policies for the U.S., such as the duration of vaccine protection and whether or not a booster dose will be needed, whether or not the vaccine will also prevent infections with other HPV types, and what might occur to rates of cancer if women change their screening practices after being vaccinated. Kim and co-author Sue Goldie , professor of health decision science at HSPH, found that vaccination against HPV-16 and HPV-18 would lead to lower cervical cancer rates and be economically attractive if high coverage can be achieved in the most important target group of 12-year-old girls, and if vaccine protection against infection lasted for at least 20 years. The study predicted that if most 12-year-old girls were vaccinated, their future cervical cancer screening could begin somewhat later than currently recommended and be conducted less frequently (i.e., every 3 to 5 years). 

At an additional expense, a catch-up program for girls between 13 and 18 years of age appears to offer benefits and be reasonably cost-effective compared to other vaccine programs in the U.S. The cost-effectiveness of extending the catch-up program to 21 years of age is less certain, and depends on whether the vaccine will eventually be proven to prevent other cancers caused by HPV-16 and -18. Including women to age 26 was consistently not cost-effective because the vaccine is quite expensive, but is less effective in women who are already sexually active. Current CDC recommendations and a recent CDC summary suggest routine vaccination of girls aged 11-12 and catch-up vaccination of girls and women aged 13 to 26. There is no absolute criterion that dictates whether a vaccine or public health intervention is cost-effective in the U.S.; however, most policy-makers agree that interventions that have a cost-effectiveness ratio less than $50,000 per quality-adjusted life year (QALY) gained, a metric used to describe cost-effectiveness, are very good value for money. While vaccination of 12-year-old girls was less than this threshold, vaccinating girls into their mid- to late-20s as part of a catch-up program was not. Kim and Goldie caution that these results could change if future information shows that vaccine protection does not last, or if there is an unexpected increase in other cancer causing HPV types not included in the vaccine. 

Kim emphasizes, "Our results are the best prediction we can make with the information available now, but it will be critical to update the analysis as we learn more about the long-term vaccine effects." An editorial, "Human Papillomavirus Vaccination - Reasons for Caution," by Charlotte J. Haug, MD., PhD. Editor in Chief of the Journal of the Norwegian Medical Association, also appears in this issue of NEJM. A long-term followup study of HPV vaccination is underway in Norway. Kim and Goldie also emphasize that it will be important to achieve high coverage among all 12-year-old girls, and not just a small subset, and to ensure girls are screened for cervical cancer beginning in their early- to mid-20s, since HPV types not included in the vaccine can still cause cancer. From a public health perspective, if women who are at continued risk for HPV infection and cervical cancer are not regularly screened, and if only some adolescents have access to the vaccine, cervical cancer rates in the U.S. may not change. Ensuring U.S. women equal access to both preadolescent vaccination and adult cervical cancer screening, is imperative. The analysis was funded by the National Cancer Institute, the Centers for Disease Control and Prevention, and the American Cancer Society. Similar work in developing countries was funded by the Bill and Melinda Gates Foundation. The article, "Health and economic implications of HPV vaccination in the United States," will appear inThe New England Journal of Medicine, August 21, 2008, Volume 359, Number 8. Harvard School of Public Health is dedicated to advancing the public's health through learning, discovery, and communication. More than 400 faculty members are engaged in teaching and training the 1,000-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children's health to quality of care measurement; from health care management to international health and human rights.

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Cervical Cancer Vaccine Sparks Debate (Yahoo News)

21 States Want To Make Shot Mandatory, But Some Say That Would Send Mixed Messages. A girl gets a cervical cancer vaccination. Twenty-one states and the District of Columbia want to make the vaccine mandatory for sixth-grade girls. (CBS) Even though Ken Alexander still likes to think of 14-year-old Audrey as his little girl, he's already had her vaccinated against a very grown-up disease: the sexually transmitted human papillomavirus, or HPV, that can cause cervical cancer. "It's my job to see that she gets what she needs to protect herself,'" he says. "Even if you think you aren't at risk, you are," adds Audrey. "You may do things that you don't think you're going to do now that may happen and you get cervical cancer." Millions of Americans have seen the ad blitz for Merck's new drug Gardasil. The vaccine promises to reduce the number of HPV related cervical cancers by more than 70 percent, CBS News correspondent Cynthia Bowers reports. The FDA only approved Gardasil in June and already, there is talk of making the $360 vaccine mandatory for the 2 million American girls who enter the sixth grade every year. But some worry that may sends a mixed signal by protecting girls against a sexually transmitted disease while at the same time telling them they shouldn't have sex. 

Illinois is one of 21 states and the District of Columbia that have introduced legislation that would put HPV on the school shot sheet along with smallpox and measles shots. State representative Naomi Jakobssen authored the bill in Illinois. "I want to make sure that every family, every young girl, has the information about the vaccine, about the potential risks of not having it," Jakobssen says. Ken Alexander understands. He's not only a dad, he's an expert on pediatric infectious diseases at the University of Chicago. He agrees Gardasil is a breakthrough, but says the final decision should be made by the parents. "Do I believe that teenage girls should be immunized? Absolutely. But is it something that we are in position to sort of ramrod down people's throats? Not yet," Alexander says. Most bills do allow parents to opt out, because the question remains: Where to make this decision - at the statehouse ... or your house. 

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Cancer vaccine linked to rise in adverse side effects among women (Yahoo News-06/06/2008)

A new cervical cancer jab has been linked to an increase in the number of women and girls suffering bad reactions to vaccinations. The first annual report of the Gardasil cervical cancer vaccine for New South Wales has shown that there has been a 1600 percent surge in adverse reaction to the injection among those who were immunised last year. Dizziness, nausea and even collapse are some of the reported reactions. NSW Health said that it is monitoring the situation closely, but said the results did not outweigh the benefits of the vaccination program. Australian-developed Gardasil vaccinations were introduced to girls aged 12 and 13 through federal Government-funded school programs last year. They are also offered free to 13- to 18-year-olds as part of a catch-up program, and to young women aged up to 26. "One of the reasons we are very careful to track immunisations is that a trial is one thing but we also want to check what happens in the real world," News.com.au quoted Dr Jeremy McAnulty, NSW Health's director of communicable diseases, as saying. "All vaccines have some usually very minor side-effects but we are keen to see if some major ones emerge," he added. However, McAnulty insisted that the benefits of the vaccine in preventing human papillomavirus (HPV), which can lead to cervical cancer, were overwhelming. He said that most of the adverse reactions were recorded by nurses during school-based immunisations and none were life-threatening. According to NSW Public Health data, there were 224 official reports of adverse events linked to immunisation last year - 133 of which were in females aged between five and 24. 

On contrary, there were only 70 in total the previous year, with just eight recorded in young females. This is a 1662.5 per cent rise in reactions among young women. The data do not break down which vaccinations cause the side-effects. However, nationally, there have been 1013 reports of adverse side-effects from Gardasil from doctors, parents and patients to the Therapeutic Goods Administration (TGA). According to Women's Forum Australia director and health researcher Melinda Tankard Reist, the real number of reactions may be significantly higher. "I am not surprised that there has been an increase in reported reactions," she said. "Most adverse reactions are never reported so you have to multiply it by many times (to get the real figure). "The health department and the Health Minister really need to have a closer look at this vaccine and a closer look at side-effects," she added. 

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When Pap Tests Fail, and Other Concerns (Yahoo News)

Dr. Mark Einstein is director of clinical research in the gynecologic oncology division at Albert Einstein College of Medicine/Montefiore Medical Center in New York. He is chairman of the Gynecologic Cancer Foundation’s Cervical Cancer Public Awareness and Education Campaign. 

Q. About 11,000 new cases of cervical cancer are diagnosed in the United States each year. Given that precancerous changes can be detected by Pap tests, why are there so many new cases?
A. Unfortunately, the majority of women who have cervical cancer in this country — more than 50 percent — haven’t had a Pap test in over five years. Pap tests are currently the gold standard for screening for cervical cancer. They’re very effective at picking up precancerous lesions long before they become a cancer and while they can still be treated very simply.

Q. What keeps women from getting Pap tests?
A. These are often women who have difficulty accessing the system — those without health insurance or with inadequate health insurance. There are also barriers involving culture, language and lack of trust of the health care system that limit some ethnic minorities from getting screening, not only for cervical cancer but for other cancers as well.

Q. But some women who have regular Pap tests still develop cervical cancer. How does this happen? 
A. Pap tests aren’t perfect. The right cells may not have been picked up by the sampling devices when collected from the cervix, or abnormal cells may, on rare occasions, be missed. And as women approach perimenopause and menopause, there are fewer sloughed cells to be sampled, and therefore more likely to be errors in sampling. That’s why it’s so important for women to have Pap tests repeated regularly, so that if one test misses a problem, the next one will pick it up. And patients need to follow up on Pap tests. If they haven’t heard from their doctor that their Pap was normal, they should call and ask. 

Q. Nearly all cervical cancers are caused by HPV, so why don’t health care providers replace the Pap test with the HPV test?
A. Many women will have an HPV infection, but few will develop a cervical precancerous lesion or cancer as a result. The sensitivity of the HPV test is extremely high. At any given time in this country, 27 percent of women will have a positive HPV test. Currently, 5 to 10 percent of Pap tests are abnormal. If we switch to doing HPV tests first, we’re going to be recalling upwards of 30 percent of our patients for abnormal tests. This may change in the future as more studies are done, but currently the best way to prevent cervical cancer in sexually active women is to get a Pap test regularly and HPV testing when recommended.

Q. Why are HPV tests recommended for women over 30, but not younger women?
A. In women under 30, HPV infection is extremely common, but most of those infections will go away on their own. These infections are less common but tend to be more persistent in older women, and HPV infections that persist raise a woman’s risk for cervical cancer. So in women over 30, the HPV test is an extra screening tool. If the Pap and the HPV tests are normal, which they are for the majority of women, we don’t have to do another Pap for two or three years. And if an HPV test finds an infection, though it can’t tell the exact type of HPV that’s the cause, it will tell me whether it’s high risk or low risk, which will help me determine how to effectively follow the patient.

Q. For precancerous lesions, when is the wait-and-see approach advisable?
A. Typically if a woman has a low-risk lesion, we observe her for a period of time, having her come to the office every three to six months. This is a bit of a dilemma, though, because physicians don’t have a crystal ball to know if these lesions are going to progress to a higher-risk lesion. Generally in younger women, low-risk lesions will resolve on their own, but in postmenopausal women, we have to look at the whole clinical picture to make a determination. High-risk lesions are less likely to go away without treatment. About 500,000 women get one of those in this country every year, and in most cases, their doctor will recommend an office or outpatient procedure to remove the area of concern. 

Q. Can an HPV infection be treated with a vaccine?
A. Not currently, but there’s a whole spectrum of therapeutic vaccines in clinical trials. These will be important to the 2 to 3 percent of patients who can’t clear an HPV infection — often women immunocompromised because of HIV or chronic steroid use, but also some women with healthy immune systems.

Q. What are the treatment options for women with cervical cancer? 
A. Most women diagnosed with cervical cancer in the United States are at an early stage and can often be managed with surgery alone. For microscopic lesions, sometimes just removal of that portion of the cervix or a simple hysterectomy — removal of the uterus and cervix alone — is offered. If there’s a visible lesion, treatment is more often a radical hysterectomy, meaning also removing the tissues next to the uterus, the upper part of the vagina and lymph nodes. If the tumor has spread beyond the cervix, called locally advanced cervical cancer, we recommend radiation therapy, often with a little chemotherapy. This is just a different way of treating the cancer, but survival rates are still very good. If the tumor has spread, we offer chemotherapy as the primary therapy. 

Q. If a woman would like to have children in the future, what other option does she have?
A. For some women with microscopic or very small visible tumors who want to maintain their fertility, we can offer a newer technique called a radical trachelectomy, where the cervix, the tissues around it and the upper vagina are removed. We leave the uterus and put a stitch around the lower portion of the uterus to help maintain a future pregnancy. These women can still become pregnant in the future; some may need medical assistance. 

Q. In cases where a doctor presents more than one treatment option, how does a woman decide what to do?
A. There are gray areas, and for these I always recommend a second opinion with a gynecologic oncologist. They treat the majority of women with cervical cancer in the United States, and they’re most up to date on its treatment. 

Q. Would a woman with cervical cancer benefit from joining a clinical trial?
A. I always advise patients to join clinical trials because they often get a lot more from them than from standard treatment. Usually the patient gets at least the standard of care for her cancer, plus more testing and more treatment. Clinical trials are not for everyone, though, so every woman needs to make a decision about this in consultation with her doctor, and weigh all the risks and benefits.

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Britain planning cervical cancer efforts (Yahoo News-20/07/2008) 

Hundreds of thousands of teenage girls in Britain will receive a vaccination against the disease that can cause cervical cancer, a health official says. British Public Health Minister Dawn Primarolo said the low cost of the Cervarix vaccine allowed the agency to arrange the September vaccination efforts, The Sunday Times of London reported. Primarolo, who will officially announce the program Monday, said providing the human papilloma virus vaccine to as many as 300,000 girls ages 17-18 is part of the government's ongoing fight against cervical cancer. "Our policy to vaccinate girls against cervical cancer is one of the biggest public health campaigns in recent history. It will mean up to 400 lives will be saved each year," the minister said. The Times said the vaccine is designed to guard against two forms of the sexually transmitted disease, which has been found to have caused 70 percent of cervical cancer cases. 

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Cancer vaccine linked to illness (Yahoo News-06/07/2008)

Rise in bad reactions to vaccinations 
Linked to cervical cancer vaccine 
Doctors stress benefits outweigh side effects 
The new cervical cancer jab is believed to be behind a huge jump in the number of women and girls suffering bad reactions to vaccinations. The first annual vaccination statistics for New South Wales to include Gardasil reveal a 1600 per cent surge in reported adverse side-effects among young females who were immunised last year. These include allergic reactions, collapsing, dizziness, nausea and unexplained illnesses. New female cases pushed the total adverse reactions to immunisations last year to the highest on record. NSW Health says it is monitoring the situation closely, but said the results did not outweigh the benefits of the vaccination program. Australian-developed Gardasil vaccinations were introduced to girls aged 12 and 13 through federal Government-funded school programs last year. They are also offered free to 13- to 18-year-olds as part of a catch-up program, and to young women aged up to 26. "One of the reasons we are very careful to track immunisations is that a trial is one thing but we also want to check what happens in the real world," Dr Jeremy McAnulty, NSW Health's director of communicable diseases, said. "All vaccines have some usually very minor side-effects but we are keen to see if some major ones emerge." However, Dr McAnulty stressed the benefits of the vaccine in preventing human papillomavirus (HPV), which can lead to cervical cancer, were overwhelming. Most of the adverse reactions were recorded by nurses during school-based immunisations and none were life-threatening, he said. NSW Public Health data reveals that there were 224 official reports of adverse events linked to immunisation last year -- 133 of which were in females aged between five and 24. 

In comparison, there were only 70 in total the previous year, with just eight recorded in young females. This is a 1662.5 per cent rise in reactions among young women. The statistics do not break down which vaccinations cause the side-effects. But nationally, there have been 1013 reports of adverse side-effects from Gardasil from doctors, parents and patients to the Therapeutic Goods Administration (TGA). But the real number of reactions may be significantly higher, according to Women's Forum Australia director and health researcher Melinda Tankard Reist. She said: "I am not surprised that there has been an increase in reported reactions. "Most adverse reactions are never reported so you have to multiply it by many times (to get the real figure). "The health department and the Health Minister really need to have a closer look at this vaccine and a closer look at side-effects." Federal Health Minister Nicola Roxon said the Government planned to continue the cervical cancer immunisation program. "There are stringent safeguards in place to ensure vaccines in Australia are tested for safety by medical experts," she said. According to the TGA, 3.7 million doses of Gardasil have been administered in Australia and, since October last year, the overall rate of adverse reactions has been decreasing. Dr Rachel David, director of public affairs at pharmaceutical company CSL, insisted its vaccination was safe but said the company was also monitoring any adverse reactions. 

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Merck cancer vaccine not cleared for older women (Reuters-25/06/2008)

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday. Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are "issues" that preclude approval within the expected review time frame, Merck said. Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. The company for now is dropping plans to pursue that expansion, a spokeswoman said. Shares of the New Jersey-based drug maker, which also reiterated its long-term revenue and earnings targets, fell 1.2 percent in morning trading. Gardasil, approved in June 2006 for preventing cervical cancer and genital warts in females ages 9-26, has been one of Merck's most successful newer products and has helped the company recover after the 2004 withdrawal of its Vioxx arthritis treatment. The Gardasil setbacks could raise concerns about the degree of growth that Merck can hope to achieve with the product, which is the world's first vaccine to prevent cervical cancer. A Merck spokeswoman said the agency has specific questions regarding Gardasil's effectiveness in this older age group. The company said it had already discussed the questions with the FDA and expects to respond to the agency in July. "Once we go back to the FDA, we'll have a better sense of what the review timing looks like," spokeswoman Amy Rose said. The letter does not affect Gardasil's current approval for females ages 9 to 26, Merck said. Global sales of Gardasil rose 7 percent in the first quarter to $390 million. Cowen and Co has predicted annual sales of the vaccine would reach $1.9 billion in 2008 and jump to $3 billion by 2012. Gardasil has benefited from lengthy delays in approval of GlaxoSmithKline's rival Cervarix vaccine. The FDA in December issued a complete response letter for Cervarix, meaning it had completed its review of the product but had further questions about it. Merck shares fell 43 cents to $36.60 in morning trading on the New York Stock Exchange.

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Ending Cervical Cancer Featured At Summit; QIAGEN CEO Issues A Call To Global Women Leaders (Yahoo News)

QIAGEN was featured this week for its efforts to eliminate cervical cancer at the 14th annual Global Summit of Women in Hanoi, Vietnam. CEO Peer Schatz came to this prominent international platform to issue a call to other leaders in business, NGOs and governments to join him and campaign to create a cervical-cancer-free world. "Nearly 500,000 women around the world are diagnosed with cervical cancer every year - a shocking number considering that it's a highly preventable disease," Mr. Schatz told ministers from more than 60 countries at a roundtable on the opening day. "However, QIAGEN and partners such as the summit's Global Consortium of Women to End Cervical Cancer are showing that where there is a will there is a way. I urge you to join us. The tools are there; they just need desire and commitment to put them to work." The Global Summit of Women annually brings together more than 1,000 senior-level women in business, government and advocacy, and is often called the "Davos for Women." It celebrates women's leadership by bringing together business and governmental professionals to work together to improve the economic power and well-being of females throughout the world. At last year's summit, President Irene Natividad announced the launch of an international "consortium to end cervical cancer." The consortium "aims to educate women about cervical cancer prevention and encouraging governments to provide easy access to the latest methods of prevention and detection, including HPV testing and vaccination." Human papillomavirus (HPV) is the primary cause of cervical cancer, and QIAGEN has developed the only FDA- and EU-approved test for high-risk types of the virus.

"We are delighted to have corporate leaders such as QIAGEN partner with us. Together we can leave the legacy of a cervical-cancer-free world to the next generations of women," said Ms Natividad. "We have made huge strides with women's empowerment. Yet, too often, an obstacle prevents millions of women from living healthy, productive lives: cancer. Cervical cancer kills more than a quarter million women each year, and nearly all of these deaths are preventable. New vaccines and a highly accurate test for HPV have the power to eliminate this devastating disease. But we need help in assuring access to these medical advances for all women, and we welcome QIAGEN's commitment and leadership." In addition to its digene HPV Test, which QIAGEN distributes widely in the United States, Europe and elsewhere, the company is partnering with the non-profit organization PATH to develop a specially designed version of the screening test for low-resource countries. This new test is sensitive enough to identify the largest number of women at risk - a critical characteristic when a woman may be able to get to a medical clinic just once or twice in her lifetime. Yet at the same time, the new HPV test can be run without electricity or running water, and can be administered by workers with minimal training. "Public-private partnerships are essential to advancing the health agenda for women, and QIAGEN is committed to leading the way," Mr. Schatz told the audience at a panel discussion on corporate social responsibility at the summit. "We look forward to working in tandem with the many partners we have found at this summit and elsewhere."

About HPV and cervical cancer
Worldwide, cervical cancer affects nearly 500,000 women annually and, after breast cancer, is the second most common malignancy found in women. Cervical cancer is caused by "high-risk" types of the human papillomavirus (HPV), which are sexually transmitted. It's estimated that 80 percent of women will get an HPV infection at some point in their lives. However, in most cases, the infection goes away or is suppressed by the body without causing problems. It is only infections that persist that can cause abnormal cells to form that may develop into cervical cancer if not detected and treated early. One report from the World Health Organization estimates that only about 5 percent of women had been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world.

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UNC study firms up promise of potential new cervical cancer screening tool (Yahoo News-21/05/2008)

New research into the causes of cervical cancer appears to lend weight to the promise of a potential early detection method that could help prevent the disease. According to a study involving scientists from the University of North Carolina at Chapel Hill, persistent infection with human papillomavirus (HPV) could be a useful clinical marker for increased risk of cervical cancer, the second most common cancer in women worldwide. HPV is a sexually transmitted virus that can cause high-grade cervical lesions, increasing a woman’s risk of developing invasive cervical cancer. Currently, Pap smear tests are widely used in screening programs aimed at detecting changes in the cervix before a cancer develops. However, testing for HPV infections has the potential to be more sensitive for future cervical cancer screening programs. In the study – thought to be the first of its kind and published online in the American Journal of Epidemiology – scientists reviewed 41 existing studies including over 22,500 women to systemically evaluate the association between HPV persistence and high-grade lesions or cervical cancer.

Jennifer Smith, Ph.D., research assistant professor of epidemiology in the UNC School of Public Health and senior author of the paper, said: “We found that a persistent HPV infection of six months to one year was consistently associated with a woman’s increased risk of high-grade cervical lesions or cervical cancer.” Smith is also a member of the UNC Lineberger Comprehensive Cancer Center. There are approximately 14 high-risk types of HPV that cause invasive cervical cancer. The two most common types are 16 and 18, which have different viral genetic patterns. These virus types are responsible for about 70 percent of invasive cervical cancer and 50 percent of high-grade lesions worldwide. “The next step will be to develop a consensus definition of HPV ‘persistence’ that can then usefully inform clinical practice for future cervical cancer screening programs,” Smith said. “Additionally, we need more information on whether the persistence of specific HPV types – such as 16 or 18 – is associated with relative differences in increased risk.” “In the future, measuring persistence of HPV infection may optimize screening for cervical cancer by increasing sensitivity while maintaining comparable specificity to Pap smear testing,” Smith said. “What that means, essentially, is that we might be better able to identify potential cervical cancer cases that could otherwise go undetected.”

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