CERVICAL CANCER

Glaxo says cervical cancer vaccine works for longer (Yahoo News-14/05/2008)

GlaxoSmithKline said on Wednesday new data showed its Cervarix vaccine generated sustained, high levels of neutralizing antibodies against the two most common cervical cancer-causing virus types for 6.4 years. Glaxo said the data, from an extended follow-up study, showed the longest duration of sustained neutralizing antibody levels reported against both virus types HPV 16 and 18 with a cervical cancer vaccine to date. Experts believe that neutralizing antibodies -- so-called because they have the ability to neutralize cancer-causing virus types and prevent them from infecting cells in the cervix -- are essential for cervical cancer protection.

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Sanofi dismisses GSK cancer vaccine (Yahoo News-07/02/2008)

GlaxoSmithKline’s rival has criticised as inferior its new cervical cancer vaccine Cervarix in an attempt to shore up an early lead in its competitor product. Sanofi Pasteur MSD has been wooing investors this week with presentations claiming greater proven health benefits from Gardasil, which was developed by Merck of the US, in preventing human papilloma virus infections, the leading cause of cervical cancer. Gardasil has already been launched in the US and Europe, while Cervarix, which began development more recently, has been struggling to catch up. It received European approval last year but the Food and Drug Administration is still demanding extra information on Cervarix. This could delay its US launch as late as 2010. Philippe Monteyne, head of global vaccine development at GSK, said positive and constructive exchanges were continuing with the FDA. “The scientific evidence shows we have the best possible cervical cancer vaccine . . . the confidence is there.” The fight between Gardasil and Cervarix reflects the importance of a fast-expanding market for pharmaceutical companies for high-priced vaccines estimated to be worth billions of dollars in annual sales. Both products sell for about €330 ($482.5) for a course of three injections.

Mr Hoch said Gardasil had sold 3m courses in Europe last year and generated €342m in sales, making it one of the fastest-expanding and highest-earning launches in recent years of any drug or vaccine. He said Gardasil had dominated Cervarix, winning market share of more than 90 per cent in most important European markets. The exception is Austria, where Gardasil’s share of the market is 88.8 per cent, which Mr Hoch said was partly because GSK had offered a discount, selling a course of Cervarix injections at €220. He criticised GSK’s head-to-head study of Cervarix and Gardasil for its small sample size, use of people older than the vaccine’s target population, and use of a test of efficacy that was not standardised. He said claims that Cervarix would provide protection against a number of strains of HPV remained speculative.

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Older women warned off cancer vaccine (Yahoo News-04/05/2008)

A LEADING cancer specialist has warned older women off getting the cervical cancer vaccine and hit out at the drug regulator for approving the jabs in the first place. Gerald Wain, a gynaecological oncologist at Westmead Hospital in Sydney, says it was "not easily understood" why the Therapeutic Goods Administration (TGA) had approved Cervarix for use in women aged 26 and 45, a criticism defended by the manufacturer GlaxoSmithKline. Cervarix is the sister vaccine to Gardasil and both Australian-pioneered medicines have been approved for use in girls and young women to block strains of human papilloma virus (HPV) known to cause 70 per cent of cervical cancers. Gardasil is available free to under 27-year-olds through the national immunisation program, and Cervarix has been pre-approved to join the same scheme. Dr Wain says while the drug has proven benefits in younger women, the approval and "excessive" marketing of Cervarix to older women was not justified. He wrote in the latest Medical Journal of Australia that the vaccine, which costs older women $450 for three injections, had shown an "absence of efficacy data and uncertain population benefits" among older women. 

"HPV vaccines allow the opportunity to enlist the woman's own immune system to develop neutralising antibodies, but studies indicate that current vaccines will only be effective if administered before exposure," Dr Wain said. "In the older age group, the vaccine is likely to be of substantially reduced efficacy because of either previous exposure or reduced risk of future exposure." He criticised the TGA for approving registration of the product for older women, suggesting the move was in breach of WHO guidelines for the evaluation of vaccines. Dr Wain, the former scientific director of the NSW Cervical Screening Program, said he was also concerned "excessive promotion" potentially diverted attention away from established methods of cervical cancer prevention, such as Pap smears. "It is important that the benefits of these two approaches to cervical cancer prevention are not confused," he said. GSK vaccines medical director Su-Peing Ng said the company agreed the best time to vaccinate was before exposure, but it was difficult to predict a woman's past and future exposure to HPV. "The potential for benefit in older women is based on the fact that sexually active women, regardless of age remain at risk of acquiring a cancer-causing HPV strain," Dr Su-Peing said. She cited research published in the same journal last month by scientists involved in the Cervarix trials, which backs the use in older women. It stated that "there is considerable potential for individual benefit" for this age group. 

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HPV test may be better cervical cancer predictor (Yahoo News-24/03/2007) 

For years now, the Pap test has been the best way to detect the early signs of cervical cancer. But some doctors say that another test -- one that looks for the virus that causes cervical cancer, not just it's effects -- may be the better way for detecting women at risk of the disease. "This is the way to go ... to test for the thing we want to prevent, which is the virus," says Dr. Eduardo L. Franco from the Division of Cancer Epidemiology at McGill University in Montreal. HPV is a common sexually transmitted virus. It's estimated that about 28 per cent of women have had an HPV infection. There are more than 100 different strains, many of which cause no symptoms. But some subtypes cause genital herpes. Four have been linked to cervical cancer. This week, the federal government announced $300 million to help fund the introduction of new vaccines to block infection with some of the strains of HPV. The vaccines would be targeted at young girls, before they become sexually active. But there are millions of women who won't be candidates for the vaccine. Doctors are now looking closely at a test that will tell them whether they have an HPV infection -- and in particular the strains that cause cervical cancer. 

"It doesn't mean you have cancer of the cervix, it doesn't mean you will get cancer of the cervix. But it will tell you that you do have an increased risk," said Dr. Frank Thompson of MDS Labs. The test isn't widely known or used yet. It's provided by MDS Laboratories and at some hospitals. It analyzes the DNA taken from cells around the cervix, and so is similar to the standard pap test. Some doctors think that it should be made more widely available. "The HPV test is far superior to the Pap to identify cervical cancer precursors," says Franco. Researchers in Denmark found that in women over 40, the HPV test did a better job that the Pap test in predicting which women would develop those abnormalities. In fact, one-quarter of the women tested who showed no problems on their Pap test yet had a positive HPV test develop cervical abnormalities within five years. Franco says that Canada may be behind the times. He notes that some clinics in Europe and the U.S are offering the HPV test first. Only women with cancer-causing strains are then given regular repeat Pap tests, because only those women are at risk of developing cervical cancer. Those negative for the cancerous strains of HPV may not need regular Pap tests. "Professional guidelines (in Canada) are not there yet. This is a new area of science emerging," he says. 

In fact researchers in B.C. are about to start a trial to see whether HPV testing can replace the Pap smear to screen women for cervical cancer and whether the period between Pap smears can be extended from one or two years to four years. But other doctors believe the current Pap test remains the gold standard. The test detects pre-cancerous cells developing on the cervix. Women who have abnormalities are then referred on to coloposcopy clinics that analyze where suspect tissue is removed. The HPV test picks up infection even when there are no symptoms. In many cases, the virus clears on its own. "If we did this test on every single woman like the Pap test, we would identify a large number of positive cases," said Dr. Nancy Durand, a gynecologist at Toronto's Sunnybrook Hospital. "Sometimes it's translated by women into 'I am destined to get cervical cancer,' and that's not the case." "It also picks up a lot of women with the virus who do not have significant disease." The Canadian guidelines now suggest doctors use the HPV test only after a woman has had an abnormal Pap smear. If she is found to have the strains linked to cervical cancer, then she would continue to be monitored closely. The test also has to be paid for by the woman, a cost of about $90. 

Durand has found the HPV test can have other consequences. It goes on a woman's medical record as a cancer risk -- even though in many patients it will never cause a problem. "I've had cases in my own practice where patients were declined life insurance or disability insurance on the basis of their results." That's why she believes the Pap test remains the key tool for finding early cancers caused by the virus. But her big concern is that many Canadian women still don't get a regular Pap test, even though it is covered by provincial health plans. "The problem is we're not reaching (enough) women with that test." 

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Glaxo seeks approval for cervical cancer vaccine. Glaxo submits cervical cancer vaccine to FDA for approval, challenging Merck's first-to-market Gardasil. (CNNMoney.com-29/03/2007) 

GlaxoSmithKline said it submitted an application for its cervical cancer vaccine Cervarix to the Food and Drug Administration, bringing it one step closer to challenging Merck's now-dominant Gardasil. Cervarix, if approved, would be used to prevent strains of the sexually-transmitted human papillomavirus, which can cause cervical cancer. In an interview Glaxo chief executive JP Garnier called Cervarix "the ultimate insurance for cervical cancer." Garnier said Cervarix could be on the market by the end of 2007, if the FDA grants the vaccine "fast track" review status and then approves it. Merck's Gardasil was launched in 2006 and is the only cervical cancer vaccine available on the market. Both Gardasil and Cervarix have been hailed by analysts as potential blockbusters, which the drug industry desperately needs to bolster pipelines as some of its top earners lose patent protection. Gardasil has the early advantage since it came to market first. Gbola Amusa, analyst for Sanford C. Bernstein, projects $2.5 billion in peak annual sales for Gardasil and $1.5 billion for Cervarix. About 10,000 women are diagnosed with cervical cancer every year, and 4,000 die from it, according to the Mayo Clinic, one of the most renowned cancer research centers.

1-visit screening, prevention for cervical cancer holds promise 2-Apr-2007
STANFORD, Calif. -- A method of screening women in Ghana for early signs of cervical cancer and providing preventive treatment at the same visit appears to be safe, acceptable to women and feasible, according to a study by a researcher at the Stanford University School of Medicine. If this technique can be scaled up effectively, it could help prevent one of the leading causes of cancer death in women in developing countries, said Paul Blumenthal, MD, MPH, acting professor of obstetrics and gynecology. He is the lead author of the study, which will be published in the April issue of the American Journal of Obstetrics and Gynecology. In developed countries such as the United States, women receive a regular Pap smear to detect early signs of cervical cancer. Those with abnormalities on the Pap smear are called back for follow-up treatment. Although this approach is effective at detecting and eradicating precancerous abnormalities, it requires a degree of infrastructure that isn't often available in developing countries. "Pap smears require equipment such as slides, reagents and even a working microscope, which might not be available in developing countries," said Blumenthal. He carried out this work while on the faculty at Johns Hopkins University, in collaboration with the university's international health affiliate JHPIEGO and the Ghana Cervicare Group.

Almost 80 percent of the 490,000 cases of cervical cancer reported worldwide each year are in developing countries, such as Ghana. Each year, more than 250,000 women die from the disease. According to Blumenthal, for women in developing countries who survive childbearing, cervical cancer is often the next potentially fatal reproductive health issue they face. The technique used in this study is one that has been known for many years. A doctor or nurse applies acetic acid, essentially vinegar, to a woman's cervix. Precancerous areas stand out as white regions against the pink, normal cervical tissue. The doctor or nurse can then freeze away the white regions using a technique called cryotherapy, which involves a commonly available gas, effectively eliminating the abnormality and preventing future cancer. This single-visit procedure eliminates the need to call women back to the clinic for repeat testing and requires less infrastructure than other methods of detecting cervical cancer. In this study, the researchers recruited women in the Ghanaian city of Accra. They found that of the 3,665 women screened, 90 percent said they were satisfied with the procedure. Of the 427 women who had abnormalities removed, most experienced some pain, but only 5.6 percent of women came back to be seen for a problem after the therapy. One year later, only 2.6 percent of the women they treated had additional abnormalities turn up.

Blumenthal said these results are a good indication that a one-visit approach to cervical cancer screening could be effective in Ghana's urban areas. However, this study didn't address whether the technique can be effective in a rural setting or whether the government would be able to scale up the procedure to treat women nationwide. A follow-up study is under way in rural Ghana. Blumenthal also said that related projects by the World Health Organization are being conducted in several other African nations. If the technique proves widely effective, the governments will need both financial and logistical help scaling up the procedure to make it generally available. "The real needs are the start-up costs, getting the projects off the ground," he said.

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Cervical Cancer Screens Effective But More Can Be Done (HealthDay News-29/04/2008)

Screening for cervical cancer reduces the risk for all types of the disease in women of all ages, say Swedish researchers. They also concluded that better follow-up of women who have cervical cancer screening could lower rates of the disease. The researchers reviewed data from the National Cervical Cancer Screening Registry on 1,230 cervical cancer patients diagnosed between 1999 and 2001, and 6,124 age-matched women who hadn't been diagnosed with cervical cancer. Women who hadn't had a Pap smear screening test within the recommended three-year interval were 2.5 times more likely to be diagnosed with cervical cancer than women who had regular Pap tests. Women who didn't have regular screening were also nearly five times more likely to be diagnosed with advanced cervical cancer than those were had regular screening. Regular screening reduced the risk for all types of cervical cancer and reduced the risk of women between ages 23 and 30, which were new findings, according to the researchers. They noted that screening didn't completely protect women from cervical cancer. Women who were screened at the recommended interval and were found to have abnormal cells were 7.6 times more likely to develop cervical cancer than women who were screened and had normal results.

Women with abnormal Pap results accounted for 11.5 percent of all cervical cancer cases. This increased risk was not noted in women diagnosed with advanced cervical cancer. The study was published online April 29 in the Journal of the National Cancer Institute. The researchers said their findings show that irregular screening is the most important risk factor for incident cervical cancer and that abnormal smears, if not followed up by a biopsy, are also an important risk factor. In an accompanying editorial, Jack Cuzick, of the Cancer Research UK Centre in London, emphasized the importance of systematic audits of cancer screening programs. "Audits, such as the one described (in this study), need to become routine within screening programs if screening is to achieve its full potential," Cuzick wrote. These reviews identify areas of screening programs that are ineffective and need to be restructured and improved.

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Anti-cancer jab shunned: One in three girls refuses vaccine to guard against cervical virus (Yahoo News-24/04/2008)

One in three girls offered the vaccine in a pilot study refused to take the jab. A vaccine against the virus that causes cervical cancer may struggle to reach enough girls, a pilot study has found. Almost one in three schoolgirls offered the Human Papilloma Virus vaccine in the trial failed to take up the jabs. The results cast doubt on whether a national vaccination scheme, due to start later this year, will fully succeed. The trial in Manchester was shunned by two Roman Catholic girls' schools, while some parents refused permission for their daughters to take part because they had safety fears. The £100million annual vaccine programme from September aims to protect girls aged 12 and 13 against HPV, the sexually transmitted virus which causes 70 per cent of all cervical cancer. Girls aged between 13 and 16 will also be vaccinated in a separate £200million two-year catch-up programme from autumn 2009. There are two new vaccines on the market, Gardasil and Cervarix, that can prevent infection by up to four strains of HPV, which infects almost half of women in their 20s. 

To achieve optimum success, injections need to be given before girls are sexually active because the vaccine is ineffective against existing infection. In England alone, 2,200 new cases of cervical cancer are diagnosed each year, leading to more than 800 deaths. If the scheme goes to plan, vaccination will eventually save the lives of around 400 women a year, but experts say 75 to 80 per cent of young girls would need to have the jab to achieve this. The pilot study - which used the Cervarix jabs - involved two primary care trusts in Manchester. A further eight declined to take part. The HPV vaccine was offered to 2,817 girls in Year 8 (ages 12 and 13) across 36 secondary schools last October, with two Catholic schools deciding not to participate. Each primary care trust delivered the first dose of the vaccine at the start of the study, the second dose after one month - when initial results were collected - and the third dose six months later. Parents were fully informed and had to give consent for their daughters to receive the jab, said Dr Loretta Brabin, who led the study. The main reason given by a third of those parents who did not want their child vaccinated was a lack of information on the jab and its safety. 

Just one in 33 parents was concerned about the vaccine's possible effect on teenage sexual behaviour, while one in five gave no reason. One in ten thought their daughters were too young for the jab. Dr Brabin, a reader in women's health at Manchester University, said overall uptake was 70 per cent. She said: "Around ten per cent of parents who did not let their daughters take part said they were waiting for the national programme to begin. "If they agree to join in, that would increase the uptake to 80 per cent in this area alone. "There will be a lot more publicity about the benefits when the programme gets under way." A Department of Health spokesman said: "This vaccine will save lives, and will reduce the number of women who need to be treated against the early stages of (cervical cancer). "We want as many girls as possible in the target age group to benefit from this vaccine, and we would encourage everyone who is offered it to take it."

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Hiqa gives approval to national cervical cancer vaccine (Yahoo News - 20/04/2008)


The Health Information Quality Authority (Hiqa) has approved the introduction of a national cervical cancer vaccine, recommending the immunisation of all girls aged 12 to 15. Its report on the issue, which has yet to be published, is with health minister Mary Harney, who previously said she would make a decision based on the authority’s advice. Harney asked Hiqa to study the cost and benefits of a national vaccine against the virus, which is a principal cause of cervical cancer.The move came after the Irish Medicines Board approved the use of Cervarix and Gardasil, the vaccines that guard against the human papilloma virus (HPV), which is the most common sexually-transmitted infection.The vaccines are most effective if given before sexual activity starts, but evidence shows they may still be of benefit to women aged 25 and older, depending on their level of sexual activity and exposure to the virus. International studies show 25 per cent of women of university age are infected with HPV - suggesting up to 75 per cent may still gain protection from the vaccine.

Research in other European countries found parents had mixed feelings about vaccinating pre-teen girls against HPV, with some citing ethical and moral concerns that vaccinating young girls would encourage sexual promiscuity.
Seventeen countries in western Europe have already decided to offer free vaccination to adolescent girls, and the British government plans to introduce routine immunisation of all schoolgirls aged 12 to 13 in September, with a catch-up programme for girls aged up to 18 starting in 2009. If Harney approves Hiqa’s recommendation, it will significantly benefit the pharmaceutical companies that manufacture the vaccines, Sanofi Pasteur MSD and GlaxoSmithKline. It costs about €600 to get the vaccine privately - €120 is the wholesale price - although if only one vaccine is chosen for the programme, a bidding war for the government contract is likely to reduce the price substantially. 

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HPV and Cervical Cancer: What Women and Girls Should Know

Nearly two decades ago, experts discovered a relationship between infection with HPV (human papillomavirus) and cervical cancer. Since then, these experts have learned much more about how HPV can lead to cervical cancer.
Here, what every woman and girl should know about HPV and cervical cancer.

About HPV Virus

There are more than 100 types of HPV. About 30 or so types can cause genital infections. Some can cause genital warts; other types can cause cervical or other genital cancers. (The other 70 or so HPV types can cause infections and warts elsewhere on the body, such as on the hands. Most sexually active women and men will contract HPV at some time in their lifetime. Most will never even know it. Usually, this virus does not cause any symptoms and doesn't cause disease. Often, the body can clear HPV infection on its own within two years or less. Some types of HPV, typically HPV 6 and HPV 11, cause genital warts. The warts are rarely associated with cervical cancers. They are considered "low-risk" HPV.

HPV and Cervical Cancer

Certain HPV types are classified as "high-risk" because they lead to abnormal cell changes and can cause genital cancers: cervical cancer as well as cancer of the vulva, anus, and penis. In fact, researchers say that virtually all cervical cancers – more than 99% -- are caused by these high-risk HPV viruses. The most common of the high-risk strains of HPV are types 16 and 18, which cause about 70% of all cervical cancers. If the body clears the infection, the cervical cells return to normal. But if the body doesn't clear the infection, the cells in the cervix can continue to change abnormally. This can lead to precancerous changes or cervical cancer.

Rates of Cervical Cancer

Actual cervical cancer is rare in the U.S. because most women get Pap tests and have abnormal cells removed before they turn into cancer. In 2006, about 10,000 women in the U.S. found out they had cervical cancer and 4,000 women died from cervical cancer. 

HPV Transmission

HPV types associated with genital infections are transmitted sexually, primarily through skin-to-skin contact during sexual activity. HPV can also be transmitted through oral sex. The chance of getting HPV rises with certain risk factors:
Number of lifetime sexual partners (risk increases with more partners) 
Young age: Women aged 20 to 24 are most likely to be infected, but they usually clear the HPV infection with no problems. 
Women who are sexually active with men who have other partners at the same time. 


Symptoms of High-Risk HPV Infection and Tests

When infection with high-risk HPV types occurs, there usually are no symptoms. Often, the first clue is a Pap test result that is abnormal. In a Pap test, the doctor takes a swab of cervical cells and has them analyzed in a laboratory. If the Pap test results are unclear, the doctor may order a HPV test to check the DNA type of the virus. This analysis can identify 13 of the high-risk HPV types associated with cervical cancer. It does not identify cancer. But it tells the woman and her doctor if she has a type of HPV capable of causing cancer.

Treatment of HPV Infection

A positive HPV test may not mean a woman needs treatment, at least not immediately. Having a positive test puts a woman in the "high-risk" class, alerting the doctor that she is at higher risk for cervical tissue changes and may need close evaluation. To watch for further tissue changes, the doctor may order frequent Pap tests. Or the doctor may perform a colposcopy, in which a lighted magnifying device is used to closely examine cervical tissues. Researchers have discovered that high-risk HPV viruses produce certain proteins. These proteins interfere with the cell functions that limit excessive cell growth. If abnormal cervical tissue changes progress, treatment may be needed. Among the options are surgery, laser treatment, and freezing. Pregnant women, or women considering pregnancy, should consult closely with their doctor. The risk of passing HPV on to the baby is very low. But HPV treatments can affect pregnancy, so doctors may want to delay treatment until after childbirth.

Prevention of HPV Transmission

There’s only one sure way to eliminate any chance of HPV transmission: Avoid all genital contact with another person. To reduce risk, it’s best to have a mutually monogamous sexual relationship with an uninfected partner. But keep in mind: Many people don’t know if they’re infected. Using condoms can help prevent HPV transmission but are not foolproof. The virus can be transmitted to genital areas not covered by the condom. A vaccine, Gardasil, was approved for use in 2006 for use in girls and women aged 9 to 26. Eventually, it may be approved for use in boys, too. Another vaccine, Cervarix, may be approved by the FDA in 2007. Over time, widespread vaccination will help prevent transmission of the HPV types covered by the vaccines. The Gardasil HPV vaccine protects against several high-risk strains of HPV, including HPV types 16 and 18, which account for 70% of cervical cancers. It also protects against HPV 6 and 11, which account for about 90% of genital warts. Cervarix, if approved, would protect against HPV types 16, 81, 31, and 45 – all of which can cause cervical cancer.

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Glaxo May Introduce Cervical Cancer Vaccine This Year (Update2) (Yahoo News- 9/05/2007)

GlaxoSmithKline Plc, the world's second-largest drugmaker, may market a cervical cancer vaccine this year that would compete with Merck & Co.'s Gardasil. The U.S. Food and Drug Administration could decide this month to grant Glaxo's Cervarix vaccine a faster, ``priority'' review, potentially prompting an approval decision and sale of the product by the end of 2007, said James Tursi, Glaxo's director of medical affairs for cervical cancer vaccines, at a medical meeting in San Diego. Glaxo filed for U.S. clearance for Cervarix in March, nine months after Merck won approval for Gardasil, which generated $365 million in sales in first quarter 2007. Gardasil, which protects against the Human Papillomavirus, Or HPV, is one of Merck's most important new products as it seeks to offset $800 million in lost sales from its cholesterol pill Zocor, which lost patent protection in 2006. ``Gardasil and Cervarix are both nearly 100 percent effective against the two types of HPV that cause the majority of cervical cancer cases,'' said Kevin Ault, an obstetrician and gynecologist at Emory University in Atlanta who has worked as a consultant for both companies. ``Based on the data we have right now, I would say much of the choice could come down to price.'' Shares of Glaxo, based in London, fell 43 cents to $57.39 at 4 p.m. in New York Stock Exchange composite trading. The stock of Merck, based in Whitehouse Station, New Jersey, fell 19 cents to $52.05. Both vaccines protect against forms of HPV that can cause 70 percent of cervical cancer cases. 

Vaccine Costs 

Gardasil, given in a series of three shots, costs $120 per injection. Glaxo hasn't disclosed how much it will charge for Cervarix. The vaccines may compete for as much as $8 billion in annual revenue by 2010, analyst Navid Malik of Collins Stewart in London said in a research note in March. Generally, the FDA grants priority review to products that serve unmet medical needs. Regulators take about six months to review drugs granted priority designation, compared with at least 10 months for products under standard review. Glaxo discussed selected test results for Cervarix yesterday at a meeting of the American College of Obstetricians and Gynecologists. The data were first reported last week at a medical meeting in Portugal. In women aged 15 to 55, Cervarix protected against the two HPV types that are most responsible for cervical cancer for at least 18 months at the site of infection on the cervix, Glaxo said today. 

10 Years of Immunity 

``We estimate, based what we know now about how the vaccine works, that it can provide immunity for 10 years,'' said Tino Schwarz, study author and head of the Central Laboratory at the Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg in Germany. The vaccine was 100 percent effective for as much as 5.5 years against types 16 and 18 of the human papillomavirus that causes cervical cancer and maintained an immune response at least 11 times natural levels, Glaxo reported in April. Cervarix protected against HPV types 45 and 31 for the same duration, was 68 percent effective against pre-cancerous lesions and was 38 percent effective against abnormal Pap smears, Glaxo said. The four strains cause 80 percent of cervical cancers. Cervical cancer is the second-most common cancer among women and kills 250,000 women a year, according to the World Health Organization. HPV, which causes cervical cancer, is a sexually transmitted virus, so the goal is to vaccinate girls before they become sexually active. 

500,000 Cases 

About 500,000 cases of the disease are reported every year, 80 percent of them in developing countries, the Geneva-based agency said. About 10,000 women were diagnosed with cervical cancer in the U.S. in 2006 and nearly 4,000 died from the disease, according to the American Cancer Society. While the two vaccines are similar, there some differences. Gardasil is also designed to work against two strains of HPV that cause genital warts. Cervarix uses a booster that may make it last longer. Both products use vaccine boosters called adjuvants, a substance which enhances the ability of an antigen to stimulate the immune system. Antigens are foreign substances in the body that cause the immune system to form an antibody that responds only to that particular antigen. Merck's Gardasil uses a traditional aluminum adjuvant. Glaxo's Cervarix uses a proprietary adjuvant known as AS04, which the company is seeking to prove makes its vaccine better. 

Stronger Immune Response 

A study published in the journal Vaccine last year found the immune response to Glaxo's vaccine was stronger and more sustained when made with AS04 than when made with the conventional adjuvant. Glaxo will present more detailed data on Cervarix next month at a meeting of the American Society of Clinical Oncology. Gardasil has drawn some controversy since the Merck drug was approved. Groups, including the conservative political organization Focus on the Family, have opposed making the vaccine mandatory because HPV isn't spread by casual contact like the germs that cause measles or polio. The American Academy of Pediatrics also said there wasn't enough funding to pay for the $360 vaccine or public acceptance to make it a requirement. Among growing criticism, Merck said in February it would stop lobbying state officials to require that girls receive the company's cervical cancer vaccine before they can attend school. 

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Study: Cervical cancer vaccine less effective in sexually active (Reuters)

Registered nurse Nancy Brajtbord administers a shot of Gardasil to a 14-year-old patient in Dallas, Texas. The human papillomavirus vaccine is approved for girls 9 to 26 and is most effective in women who have not been sexually active. 


CERVICAL CANCER 

Tests: Pap smear may be replaced 
People: Maternity designer Liz Lange had cervical cancer 
Backlash stops Merck push to require vaccine 
Vaccines: Mandate or choice | Who decides? 
Q&A: About the cervical cancer vaccine 
First-ever cancer vaccine approved | Price, insurance problems limit patient access 
Opinion: Our view: Rush to require promotes backlash | Governor's response: Protect life 

A vaccine designed to prevent cervical cancer significantly cut the risk of precancerous changes in women who had not already been infected with the cancer-causing virus types targeted by the vaccine, a study reports today.
The Gardasil vaccine, which has been sold in the USA since last summer, was not as effective in women who had been infected with human papillomavirus (HPV) types 16 or 18, thought to cause 70% of cervical cancer cases. HPV is the most common sexually transmitted infection in the USA, so that finding suggests that sexually active women might not be getting their money's worth out of the vaccine, which also targets two other HPV types thought to cause 90% of genital warts cases.


ON DEADLINE: Study links oral sex and throat cancer

"Just like any vaccine, it's not going to be effective in people who already have the disease," Emory obstetrician/gynecologist Kevin Ault says. About 93% of the more than 12,000 women ages 15 to 26 who participated in the international study, published in The New England Journal of Medicine, were not virgins upon enrollment. Before they received the vaccine or placebo, participants were checked to see whether they had ever been infected by any of the four HPV types targeted by the vaccine. Fewer than 1% had been infected by all four, but 27% had been infected by at least one. But the HPV test available in doctors' offices reveals only whether women are currently infected with any HPV type, not what type or whether they've been infected before. "It's important that women understand if they're sexually active, there's a chance they won't receive full benefit from the vaccine," says University of Washington epidemiologist Laura Koutsky of the trial's study group, which followed women for three years.

More than 90% of HPV infections clear up on their own. Once that happens, Koutsky says, studies suggest most women are protected against those HPV types. Lasting infection with cancer-causing HPV types can lead to cervical cancer, which is expected to kill 3,670 women in the USA this year. Gardasil is approved for girls and women ages 9 to 26. The Centers for Disease Control and Prevention recommends vaccinating girls at age 11 or 12, before most are sexually active. Many states are considering the controversial step of requiring HPV vaccination for girls entering sixth grade. University of California-San Francisco OB/GYN George Sawaya, co-author of an editorial accompanying Koutsky's study, says he's not sure what to tell sexually active patients who ask about the vaccine. "An easy answer is 'CDC recommends it,' " Sawaya says. "I've been very clear with my patients that it's hard for me to counsel them about risks and benefits." It's not known what proportion of vaccine recipients were sexually active before receiving the three-shot regimen, which costs $360. Jennifer Allen of Gardasil maker Merck says the company has not yet broken down recipients by age, which could serve as a marker for sexual activity. Allen says Merck does not yet know the total number of girls and women who have received the vaccine, but, she says, 5 million doses were distributed from last June through March 31.

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Cancer vaccine 'promotes sex' (15/05/2007)

CONSERVATIVE political groups in US states have blocked plans to vaccinate young girls against the sexually-transmitted virus that causes cervical cancer because they believe it would encourage promiscuity. West Virginia, Kentucky, Mississippi and New Mexico have rejected attempts to introduce compulsory vaccination programs of the Australian-invented vaccine Gardasil which works against the human papillomavirus (HPV), known to cause 70 per cent of cervical cancer cases. NewScientist.com reported that some conservative groups believed the the introduction of the vaccine to girls aged 11-12 years would encourage sexual activity by cutting the risks of catching sexually transmitted diseases. Texas Governer Rick Perry's order for schoolgirls to be vaccinated was blocked by the state Senate last month. Only one state – Virginia – has so far passed a law requiring vaccination. Advocates of Gardasil hope that recent trial results which show little side effects could influence the debate in 15 central and eastern US states, where legislation is still undecided.
Meanwhile, some states opting for voluntary vaccination programs are reporting positive results. Several medical clinics in New Hampshire that offer vaccination to girls aged 11 to 18 have run out of stock, NewScientist reported. The Australian Governmen has begun rolling out a $500 million national Gardasil vaccination program to protect the next generation of women against cervical cancer. About 230,000 teenagers are expected to be vaccinated for free over the next two years. 

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HPV vaccine may guard against other cancer (UPI- 18/05/2007)


A study in the British medical journal The Lancet says the new cervical cancer vaccine, Gardasil, may prevent other types of cancer. The study, which involved more than 18,000 teens and young women in 24 countries, said Gardasil was effective in preventing vulval and vaginal cancers in teenage girls and young women not infected with the human papillomavirus, The South Florida Sun-Sentinel said Friday. Gardasil was not effective in fighting precancerous lesions already formed in the vagina or vulva, but could prevent new infections and protect against exposure to other HPV strains, the newspaper said. Dr. Nicholas Tranakas, medical director for cancer services with the North Broward Hospital District, said the new research offers hope in preventing cancer. "Personally, I think the data is pretty overwhelming," Tranakas told the newspaper. "We know that we can prevent HPV infections by giving this vaccine. Society has to make the decision: Should it be mandated?" 
The study was funded by Merck, the maker of Gardasil.

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Cervical cancer shots gaining reputation as painful-(AP- 19/1/2008)

The groundbreaking vaccine that prevents cervical cancer in girls is gaining a reputation as the most painful of childhood shots, health experts say. Lauren Fant, 18, winces as she gets her third and final HPV shot from nurse Stephanie Pearson. As Austin Powers would say; "Ouch, baby. Very ouch." Health officials have touted the Gardasil vaccine as an important new protection against a cancer-causing sexually transmitted virus. In recent months, they've also noted reports of pain and fainting from the shot. During its first year of use, reports of girls fainting from vaccinations climbed, but it's not clear whether the pain of the cervical cancer vaccine was the reason for the reaction.

"This vaccine stings a lot," said Patsy Stinchfield, an infectious disease expert at Children's Hospitals and Clinics of Minnesota, speaking at a recent meeting of vaccination experts in Atlanta, Georgia. It sure does, said 18-year-old Lauren Fant. She said other shots tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in. "It burns," said the college freshman from Marrietta, Georgia. The pain is short-lived, girls say; many react with little more than a grimace. But some teens say it's uncomfortable driving with or sleeping on the injected arm for up to a day after getting the shot. Officials at Merck & Co., which makes the vaccine, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.

Meanwhile, U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002 to 2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006. But it's not clear that Gardasil's sting is related to the fainting increase, said Dr. Barbara Slade, an immunization safety specialist at the U.S. Centers for Disease Control and Prevention. Teens tend to faint from needles, so a three-dose vaccine for adolescents would be expected to prompt some added fainting, she said. Researchers aren't sure why teens faint more than other age groups, but nervousness may be a factor.

Health Library
MayoClinic.com: HPV vaccine 
MayoClinic.com: Gardasil -- who should get the shot 
Gardasil is the first vaccine approved specifically to target the human papilloma virus, or HPV, which causes cervical and vaginal cancer. The Food and Drug Administration approved it for girls ages 9 to 26. Preliminary studies indicate only 10 to 20 percent of them have gotten at least one dose.

But researchers said those rates are due to reasons other than worries about pain, including Gardasil's $120-a-shot price, limited supplies initially and mixed feelings by some parents and doctors about a vaccination that assumes girls have sex. Dr. Andy Andrews, an Atlanta-area pediatrician, said he doesn't believe the shot's ouch has diminished demand. "A lot of the older teens are coming in themselves, without a parent. So they themselves are motivated to come back in," Andrews said. A second HPV vaccine, GlaxoSmithKline's Cervarix, is under FDA review and could become available in 2008. Complaints of injection pain have not surfaced in clinical trials, said Liad Diamond, a company spokeswoman. 


 The American Cancer Society predicts that there will be more than 11,000 new cases of invasive cervical cancer in the United States in 2008. About 3,600 women will die from this disease that same year. Some researchers think that non-invasive cervical cancer is about four times as common as the invasive type. When found and treated early, cervical cancer often can be cured. Cervical cancer once was one of the most common causes of cancer death in American women. The death rate has declined by 74 percent between 1955 and 1992 in the U.S. and continues to decline each year by almost 4 percent. 

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Study determines costs of breast and cervical cancer detection among low-income women- (Yahoo News- 21/12/2007)

A new study has estimated the costs of providing comprehensive screening and diagnostic services to under-or uninsured, low-income women to identify those with breast or cervical cancer for treatment. Dr. Donatus U. Ekwueme of the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention in Atlanta and colleagues found that the median cost of screening a woman for breast cancer was $94, and the cost per breast cancer detected was $10,566. For cervical cancer, these costs were $56 and $13,340, respectively. The study is published in the February 1, 2008 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

Many deaths from breast and cervical cancer would be avoidable through the use of mammography and Pap tests, respectively. In 1990 Congress established the National Breast and Cervical Cancer Early Detection Program (NBCCEDP)—which is now the largest cancer screening program in the United States—to provide support and assistance to increase breast and cervical cancer screening among medically under-served, low-income women. Program services are available in all 50 states, the District of Columbia (DC), 4 U.S. territories, and 13 American Indian/Alaskan Native organizations. To help determine the level of funding required to reach and screen eligible women, Ekwueme and colleagues set out to estimate the costs per woman served, per woman screened and per cancer detected through this program.

The investigators collected data from July 2003 through June 2004 from nine of the 68 NBCCEDP programs operating in the United States. They found that when non-federal contributions are included, the median cost of all screening services combined was $555 per woman. Screening tests accounted for the highest cost, $221 per woman served, and public education/outreach incurred the second highest cost, $63. The analysis revealed that 58.2 percent of the program’s resources were allocated to clinical services, including screening and diagnostic follow-up, referral for treatment, and case management. The remainder of NBCCEDP’s funds were used to support non-screening activities such as data management, public education/outreach, professional education and quality assurance and improvement. The authors note that the study “provides the first systematic cost analysis in the selected [NBCCEDP] programs and is unique in that it attempts to determine the real costs of providing comprehensive screening and diagnostic follow-up services to low-income, uninsured women.” The Centers for Disease Control and Prevention is currently assessing the long-term economic issues in all of the programs within NBCCEDP. These analyses “will provide invaluable information that program directors and managers can use to make informed decisions on how to allocate NBCCEDP resources more efficiently,” the authors conclude.

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Public in dark on HPV cancer link - HPV infection is linked with most cervical cancers -(Yahoo News- 12/08/2007)


The vast majority of women do not know that most cervical cancer is caused by a sexually transmitted infection. In a survey of 1,600 women only 2.5% cited human papillomavirus as a risk factor for cervical cancer. Researchers said the results, published in the British Journal of Cancer, were "striking" considering recent publicity over the development of a HPV vaccine. Experts said the public needed to be better informed before widespread vaccination was introduced. There are over 100 different types of HPV and they are the most common sexually transmitted disease. Around 80% of sexually active women can expect to have an HPV infection at some point in their lives. If people don't know about it, they can't give fully informed consent to vaccination 

Two vaccines have been developed - Gardasil and Cervarix - which have been shown to be very effective against the strains most commonly linked with cervical cancer. In June, government advisors recommended girls aged between 12 and 13 in the UK should be vaccinated against the HPV. It has also been suggested that HPV testing should play a part in cervical screening. The disease kills 1,120 women in the UK every year. In a survey done in 2002, 0.9% of women listed HPV as a cause of cervical cancer without prompting. But researchers had hoped intense media coverage on the potential for a preventive vaccine would have raised awareness among the general public. The latest survey done at the beginning of 2007 showed a three-fold increase in the number of women who were able to list HPV as a cause of the disease - but the figure is still "extraordinarily low" they concluded. There had been an increase since 2002 in the proportion of respondents who mentioned virus or infection when asked for the causes of cervical cancer. However, understanding that the virus was sexually transmitted had not improved. 

Study author Laura Marlow, research assistant at University College London said they expected a bigger increase in awareness given the wealth of media coverage in the past few years. "If people don't know about it, they can't give fully informed consent to vaccination." She added: "The media hasn't had much effect as yet but it's all just been talk. "Once it's actually happening, the public will be more aware of what's going on." She added that people with higher levels of education had heard of HPV in the study suggesting there was awareness among some sections of the population. Jenni MacDougall, Cancer Research UK's health information manager, said it was essential that public knowledge of HPV kept pace with developments such as new vaccines. "HPV causes most cases of cervical cancer, yet this research shows few women in the UK realise this. "The UK's cervical screening programme saves the lives of thousands of women each year. Cancer Research UK's Screening Matters campaign encourages people to go for screening when invited, and to encourage friends and family to do the same." 

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Study: New cervical cancer test improves detection- (Los Angeles Times- 18/10/2007)

Recently approved HPV screening used with a traditional Pap smear finds more cases than the Pap alone. Using a traditional Pap smear with a relatively new screening test for the virus that causes cervical cancer significantly improves the chances of early detection, according to new research published today. The study of 12,527 women found that the combination of tests detected 51% more cancers and precancerous lesions in initial screenings than the Pap test alone. The report in the New England Journal of Medicine provided fresh evidence of the benefits of the human papillomavirus screening test, which has been approved for use with Pap smears in the U.S. since 2003. The HPV test detects genetic material from 13 types of HPV, a sexually transmitted virus that has been shown to cause cervical cancer. It differs from the Pap test, in which a sample of cervical cells is examined under a microscope for abnormalities.

The HPV test is more sensitive than the Pap smear, which sometimes fails to detect cancer. A shortcoming of the HPV test is that it also picks up the presence of transient viral infections that will never become cancerous. American Cancer Society screening guidelines say the HPV test is a reasonable choice for women 30 or older who are also getting a Pap smear. The guidelines say the test combination should be administered every three years to reduce the chance of false-positive results triggered by transient infections. Women who use only the Pap smear are screened every one to two years. The guidelines recommend against the HPV test for women younger than 30 because they are more likely to have transient infections.

The HPV test, marketed in the U.S. by Digene Corp., costs about $50, compared with $20 to $30 for a Pap smear. The Pap test is widely regarded as the most effective screening tool for any cancer. Cervical cancer death rates have tumbled more than 75% since the mid-1950s and are expected to decline nearly 4% this year. The American Cancer Society estimates 11,150 cases of invasive cervical cancer will be diagnosed in the U.S. this year, and 3,670 women will die from the disease. The study, conducted by Swedish researchers, divided women into two groups: One received both tests; the other had only a Pap smear. The women, ages 32 to 38, were tested at the start of the study and followed for an average of four years.

At the start of the study, 51% more cases of cervical cancer or precancerous conditions were detected in women who received both tests than those who received the Pap test alone. But by the end of the four-year period, the Pap test detected roughly the same number of cases. The study did not last long enough to determine whether earlier cancer detection improved the life expectancy of the women who received both tests. A second study, also published in the journal, reported that the HPV test was nearly twice as accurate as the Pap test at detecting precancerous changes in the cervix. The study of 10,154 Canadian women ages 30 to 69 found that the HPV test detected 95% of abnormalities, whereas the Pap test detected 55% of possible cancer precursors. The HPV test, however, had twice the rate of false positive results -- 6% compared with 3% for the Pap test.

The researchers, led by Dr. Eduardo Franco of McGill University in Montreal, recommended a shift to the HPV test from the Pap test. But other experts said such a change would be premature, noting that the Pap test in the Canadian study was considered less accurate than the Pap test generally used in the U.S. "The big problem with this study is that we don't know what its applicability is to us," said Dr. Carolyn D. Runowicz, an oncologist at the University of Connecticut's Carole and Ray Neag Comprehensive Cancer Center, who wrote an editorial accompanying the reports.

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Pill Poses Little Cervical Cancer Risk-(HealthDay- 9/11/2007) 

Women taking oral contraceptives are at a slightly increased risk for developing cervical cancer, but a decade after stopping the pill even this very small risk disappears, a new British study suggests. However, that finding doesn't change the recommendation for women to continue getting screened for cervical cancer, experts say. "This is good news," said lead researcher Dr. Jane Green, an epidemiologist in the Cancer Epidemiology Unit at the University of Oxford. "We have been able to estimate the lifetime risk of cervical cancer for women on the pill and find it's really quite small," she said. "The small increase in cervical cancer we see in women who are taking oral contraceptives starts to fall once pill use stops and has really gone away by 10 years after stopping use," Green said. "The pill has many other benefits, including reducing the risk of other cancers, such as ovarian cancer and womb cancer," Green added. The report is published in the Nov.10 issue of The Lancet. In the study, Green and her colleagues from the International Collaboration of Epidemiological Studies of Cervical Cancer collected data on almost 16,600 women with cervical cancer and more than 35,500 women without cervical cancer. These women had participated in a total of 24 studies.

Green's team confirmed that the risk of cervical cancer among women who use oral contraceptives does increase over time. But this increase in risk is very small -- women who take contraceptives for five years or more have only about twice the risk compared with women who never took the pill. In absolute terms, that means that a 20-year-old woman living in a developed country who uses an oral contraceptive for 10 years increases her odds of developing cervical cancer by age 50 from 3.8 cases per 1,000 women (without Pill use) to 4.5 per 1,000 women after using oral contraception. In less developed countries, where access to cervical cancer screening is more limited, that risk rises from 7.3 to 8.3 cases per 1,000 women, the researchers estimated. Similar risk was seen for invasive and localized cancer and in women who have the human papillomavirus (HPV), which causes about 70 percent of all cervical cancers, Green noted. Although the risk for cervical cancer associated with the Pill is small, Green advised women to still be screened for the disease. "Screening for cervical cancer is effective," she said. "The advice is to go for regular screenings." Eventually, Green hopes that the vaccination against the human papillomavirus will go a long way to preventing many cases of cervical cancer.

One expert agreed that the findings showed the risk for cervical cancer from oral contraceptives was very small. "This is reassuring news for women," said Dr. Peter Sasieni, from the Wolfson Institute of Preventive Medicine at Queen Mary University of London and author of an accompanying journal comment. "There is really a minimal risk from oral contraceptives, and that risk disappears fairly soon when you stop taking them," he said. "When making a decision about what from of contraception to use, women shouldn't worry about cervical cancer," Sasieni concluded. "It's not an issue," he said. However, he believes that taking oral contraceptives is another good reason to get screened regularly for the disease. "By going for regular screenings, a women can reduce her risk by 80 percent," Sasieni said.

Another expert agreed that women shouldn't worry about the Pill and cervical cancer risk. "I don't think women are basing their decision of which form of contraception to use on the risk for cervical cancer," said Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society. "People who want to use oral contraceptives should not be alarmed over the slight increase in cervical cancer risk," she said. However, women -- whether they take oral contraceptives or not -- should be getting regular cervical cancer screening, Saslow said

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Pill linked to higher cervical cancer risk-(Yahoo News- 9/11/2007)

A report in a British medical journal said women who take contraceptive pills for an extended length of time face a higher risk of cervical cancer. The study, published in The Lancet, said the risk increases the longer the pill is taken but returns to normal 10 years after use of the pill stops, Britain's Independent newspaper said Friday. Doctors also said the risk is more than outweighed by the protective effect of the pill against ovarian and endometrial cancer. The findings were based on a review of 24 studies of pill use. The report estimated that taking oral contraceptives from about the age of 20 to 30 increased the incidence of cervical cancer by the age of 50 from 3.8 to 4.5 per 1,000 women living in developed countries. In less developed countries, cervical cancer incidence rose from 7.3 to 8.3 per 1,000 women, the newspaper said. 

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Merck: Expand cervical cancer vaccine use (Yahoo News- 5/11/2007)


Study finds that Gardasil, a vaccine that targets the virus believed to be responsible for the majority of cervical cancer cases, is effective in women ages 24 through 45. Merck & Co. said a new study of its Gardasil vaccine demonstrated it was effective in an older group of women, ages 24 through 45, at preventing infection by certain strains of the virus that causes cervical cancer. 

Gardasil, which went on sale in 2006, is approved in the United States for use in girls and women ages 9 through 26. Merck said Sunday it plans to submit the new data on the older group of women to the U.S. Food and Drug Administration by the end of 2007, seeking approval to market Gardasil for use in women up to age 45. Gardasil targets four strains of the human papillomavirus, or HPV, which are believed to be responsible for about 70 percent of all cervical-cancer cases and 90 percent of genital warts. The vaccine doesn't treat existing infections of the four HPV strains, and there are other HPV strains not targeted by Gardasil that can cause cancer. Thus, women are advised to continue to undergo routine Pap screens to detect precancerous lesions. Women in this older age group may already have acquired HPV because it is transmitted via sexual activity.

Merck hopes that use of Gardasil can prevent cervical cancer caused by the four targeted HPV strains in older women who haven't yet been infected by any of them, or prevent infection by other strains if a woman is already infected. "The vaccine prevents infection and is highly effective in preventing disease" caused by the four HPV strains, said Eliav Barr, head of Merck's HPV vaccine-research program. Researchers were scheduled to present data from the Merck-sponsored study at the weeklong International Papillomavirus Conference in Beijing, which began Saturday.

In the study of 3,800 women, roughly half received three doses of Gardasil over six months while others received three placebo shots over the same period. On average, women were followed for nearly 20 months after completing the regimen. Merck said the study showed a 91 percent reduction in cases of persistent infection, low-grade cervical abnormalities and pre-cancers, and external genital lesions caused by the four targeted HPV strains among those receiving Gardasil, compared with those receiving the placebo. The study measured only incidents caused by targeted HPV strains that weren't already present in women at the start of the study or during the dosing regimen, Merck officials said.

An earlier study in girls and women ages 16 to 23 showed Gardasil was associated with a 96 percent reduction in these incidents, versus placebo. Two-thirds of the women in the new study were not infected by any of the four HPV strains at the start of the study, Barr said. The remaining one-third were infected by at least one targeted HPV strain at the start of the study, and in most cases it was only one strain. Side effects included injection-site allergic reactions, pain and swelling, and were higher in the vaccine group than in placebo.

Gardasil costs about $120 per dose, or $360 for a typical regimen. Merck (Charts, Fortune 500), based in Whitehouse Station, N.J., recorded Gardasil sales of $1.14 billion in the nine months ended Sept. 30. Gardasil is marketed in Europe by a Merck joint venture with Sanofi-Aventis (Charts) of France. Britain's GlaxoSmithKline PLC (Charts) has developed a competing cervical-cancer vaccine, Cervarix, which has been approved in Australia and Europe. Glaxo has applied for regulatory approval of the vaccine in the United States and is awaiting a decision. 

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British schoolgirls to get cancer jab-(Yahoo News- 26/10/2007)

British schoolgirls are to be offered vaccinations against cervical cancer from next year, in a scheme which could save hundreds of lives a year, officials said Friday. The introduction of the voluntary vaccinations for 12-13 year-olds from September 2008 is a recognition of the "need to do more to prevent disease and not just treat it," Health Secretary Alan Johnson said. Girls will be vaccinated against the sexually-transmitted human papillomavirus (HPV). HPV causes around 70 percent of cases of cervical cancer which kills more than 1,000 women in Britain each year.

The basic programme of vaccinations will cost the country around 100 million pounds, but experts hope this will be offset by the reductions in treatment costs later. Around 400 lives could potentially be saved each year, according to official estimates. A two-year "catch-up" campaign for girls aged 16 to 18 will begin in 2009 and girls aged 15-17 will be offered the jab in 2010. The move was welcomed by health professionals including the Royal College of GPs and Cancer Research UK. "The benefits of introducing this vaccine into the national immunisation programme will be felt by women and their families for generations to come," said Professor David Salisbury of the government's Department of Health. Each year, more than 2,700 British women are diagnosed with cervical cancer and around 200,000 women a year also have pre-cancerous changes to their cervix picked up through smear tests. Cervical cancer kills around 274,000 women worldwide every year.

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DNA test betters Pap in detecting cervical cancer: study-(Yahoo News- 18/10/2007)

The human papillomavirus (HPV) screening test for cervical cancer is far more accurate than the traditional Pap test, according to a Canadian study published Wednesday in the United States. The first round of the Canadian Cervical Cancer Screening Trial, led by Eduardo Franco, Director of the Division of Cancer Epidemiology at McGill's Faculty of Medicine, put the HPV test's accuracy in detecting pre-cancerous lesions at 94.6 percent, compared to 55.4 for the Pap test. The study is published in the October 18 edition of The New England Journal of Medicine.

The trial, funded by a grant from the Canadian Institutes of Health Research, followed 10,154 women aged 30-69 in Montreal, Quebec and St. John's, Newfoundland from 2002-2005. "We already knew before conducting this study that the sensitivity of Pap left a lot to be desired," said Franco. The Papanicolaou (or Pap) test was invented by Georgios Papanicolaou in the 1940s and requires technicians to look under a microscope for abnormalities in cell samples collected from the patient's cervix. It has been the standard screening procedure for cervical cancer for almost 50 years.

The HPV test also requires the collection of cervical samples, but the analysis process is automated and detects the DNA of high-risk HPV strains known to cause cervical cancer. "Women currently vaccinated against cervical cancer will still need to be screened, because the vaccines that are available now only prevent about 70% of all cervical cancers, and they're primarily for young women," said Franco. "The HPV test may be ideal for vaccinated women once they reach screening age, because it gives us an opportunity to monitor the protection that the vaccine is supposed to give them," he added. Cervical cancer kills more than one quarter of a million women worldwide each year.

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Cervical-cancer vaccine helps even more-(Associated Press- 19/09/2007)

A vaccine against the virus that causes cervical cancer partially blocks infection by 10 strains of the virus on top of the four types the vaccine targets, according to new data. That boosts protection - at least partially - to 90 percent of strains causing the deadly cancer, according to data presented Wednesday at a medical conference by Merck & Co., maker of Gardasil. Whitehouse Station-based Merck called it the first evidence of any vaccine providing cross-protection against other strains of the human papilloma virus, or HPV.  Dr. Stephanie Blank, a gynecological oncologist at the New York University Cancer Institute, said the finding could encourage more widespread use of Gardasil in developing countries, where some of the additional strains are more widespread and women rarely get Pap smears to detect early, curable cancers. "That could be huge," Blank said. 

Gardasil is the only cervical-cancer vaccine on the market, approved for sale in 85 countries and pending approval in 40 more; it has racked up about $1 billion in sales since its June 2006 U.S. launch. GlaxoSmithKline PLC is awaiting approval of its own vaccine, Cervarix. There are more than 60 strains of the HPV virus. About 15 are thought to cause cervical cancer; Gardasil protects against 12 of those, plus another two that cause genital warts but not cancer.  Two strains cause 70 percent of cervical cancer. Merck studies following 17,600 young women for three years found the vaccine to be 99 percent effective in blocking those strains.

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