Less frequent Pap tests now recommended for cervical cancer screening

New York, NY

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

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

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

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

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

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

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

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

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

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

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

Misread Pap Test Failure to Diagnose Cervical Cancer Malpractice Claims for Compensation

 Subscribe to Cervical Cancer News Information Links

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

Ann Arbor, MI

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

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

These are Dr. Dempsey’s results verbatim:

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

The study found:

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

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

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

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

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

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

Cervical Cancer Diagnosis Malpractice Lawsuits

 Subscribe to Cervical Cancer News Information Links

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

Helsinki, Finland

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

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

Key research findings

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Misread Pap Smear Test Malpractice Lawsuit Attorneys

 Subscribe to Cervical Cancer News Information Links

Clash of the Titans for the HPV Vaccine Market

New York City, NY

wo pharmaceutical giants are vying for the billions of dollars up for grabs in the market for vaccines against the human papillomavirus, or HPV, a sexually transmitted infection that can cause cervical cancer and genital warts.

Merck, which has had a monopoly on HPV vaccines in the United States with its Gardasil for young women, has asked the Food and Drug Administration to approve the drug to protect against genital warts in young men. In 2006, the agency approved Gardasil to protect girls and women ages 9 to 26 against certain strains of the virus that can cause genital warts, pre-cancerous genital lesions and cervical cancer.

Meanwhile, GlaxoSmithKline, which currently markets its Cervarix vaccine to young women in about 100 countries, is seeking to have the vaccine approved in the United States to protect girls and women ages 10 to 25 against certain HPV strains that can cause cervical cancer. Cervarix does not offer protection against strains of the virus that can cause genital warts.

On Wednesday, an advisory panel of the Food and Drug Administration voted that research data from Glaxo had demonstrated the safety and efficacy of Cervarix to protect young women against cervical cancer. The panel, composed of outside experts, also voted in favor of the safety and efficacy of Gardasil to inhibit genital warts in boys and men ages 9 to 26.

The F.D.A. typically follows the recommendations of such panels on drug approvals.

Glaxo shares were up about half a percent to $39.22 at the end of trading on Wednesday; shares of Merck were up about 1.9 percent to $31.55.

But industry analysts said that the drug companies faced a battle to expand the target audience in America for such vaccines because the drugs have limited effectiveness and unknown duration. They also have possible side effects like dizziness and fainting.

Both vaccines also require a series of three shots over six months. Both are most protective in young people who have not yet been exposed to the virus because they are either not sexually active or have just become sexually active and have had few romantic partners.

Indeed, because of the limited audience of young women, American sales of Gardasil have recently stalled, said Tim Anderson, an analyst with Sanford C. Bernstein. In the first half of this year, Gardasil had sales in the United States of $363 million, a decrease of 34 percent compared with the same period in 2008, according to a Merck financial statement.

Mr. Anderson said that Merck will find it harder to persuade parents and health insurers to pay for Gardasil shots to reduce the chance of developing a nonfatal condition like genital warts in boys than to market the vaccine to reduce a potentially deadly disease like cervical cancer in young women.

“You are asking a healthy teen to come to the doctor three times in six months,” Mr. Anderson said in an interview Wednesday. “Pretty much no healthy teen would ever do that, let alone to come back and get a shot, a shot that can cause a lot of pain.”

In a note to investors on Friday, Mr. Anderson forecast that in 2015, Gardasil would have 65 percent of an estimated $3.7 billion worldwide market for vaccines against the human papilloma virus, with Cervarix accounting for the rest.

If the agency ultimately approves Cervarix for use in young women, Glaxo will have to distinguish the drug as a longer-lasting and more comprehensive vaccine to gain a foothold in the United States market owned by Merck, analysts said.

Since the advent in the 1950s of the Pap test to detect precancerous cells in the cervix, death rates from cervical cancer in the United States have dropped by about 70 percent, said Dr. Debbie Saslow, the director of breast and gynecological cancers at the American Cancer Society. An estimated 11,000 women in the United States will develop invasive cervical cancer this year and about 4,000 women will die from the disease, most of whom have never had a pap test, Dr. Saslow said.

The Food and Drug Administration has approved Gardasil to protect against two strains of the virus, 6 and 11, which can cause genital warts, as well as two strains, 16 and 18, which are responsible for the development of about 70 percent of cervical cancers.

Now, Glaxo has submitted data to the agency, suggesting that its vaccine also provided cross-protection against several other strains responsible in total for about 86 percent of cervical cancers, the company said.

“Cervarix will prevent more cancers and save more lives than a vaccine without cross protection,” Dr. Barbara Howe, director of North American vaccine development for Glaxo, told the F.D.A. panel on Wednesday.

But an F.D.A. expert told the panel that it was difficult to measure protection against addition strains that cause cervical cancer.

The panel also examined safety questions about whether Cervarix could increase a woman’s risk of miscarriage or of autoimmune diseases, rare problems which Glaxo said it would follow in post-marketing studies.

Merck is also hoping for approval from the F.D.A. to protect boys and young men against the strains of the virus that can cause venereal warts.

But, although the F.D.A. panelists voted that Merck had demonstrated the safety and efficacy of Gardasil for boys, skepticism among a few panelists suggested that Merck may find it difficult to persuade boys to have shots for an uncomfortable but non-life-threatening problem that often resolves itself without medical intervention.

Cervical Cancer Malpractice Attorneys

 Subscribe to Cervical Cancer News Information Links

FDA approval for Cervarix and Gardasil recommended by committees

Washington, D.C.

Last week, the FDA received recommendations to approve two vaccines against the human papillomavirus (HPV) that causes cervical cancer.

The vaccine Cervarix is licensed in nearly 100 countries worldwide and approved by the World Health Organization, but it has been awaiting FDA approval since its initial application in 2007 raised concerns about possible side effects. Though structured as a bivalent vaccine to protect only against HPV types 16 and 18, Cervarix has been shown in a recent trial to provide cross-protection against three other HPV types and may also produce a higher degree of protection against precancerous lesions known as grade II cervical intraepithelial neoplasias (CIN2+) than the vaccine Gardasil.

Gardasil has been approved for cervical cancer protection in females aged 9 to 26 since 2006, and targets two additional HPV types that are linked to genital warts, which can occur in males, as well. A second expert committee recommended FDA approval be extended to males in that same age group. The clinical trials on which the committee based its recommendation showed that Gardasil was 89 percent effective in preventing genital warts and had no side effects, though it was less effective in those who had already been exposed to HPV.

Cervical Cancer Malpractice Attorney

 Subscribe to Cervical Cancer News Information Links

Univ. of Washington students among 10,000 participating in HPV vaccine study

Seattle, WA

The UW is involved in studies regarding a new vaccine for human papillomavirus (HPV) after UW researchers played a significant role in the development of Gardasil, an existing vaccine for the sexually transmitted infection.

Constance Mao, an assistant professor of obstetrics and gynecology at the UW, is leading the study of 102 women between ages 16 and 26 at Hall Health Primary Care Center.

The study, funded by Merck & Co., Inc., which started manufacturing Gardasil in 2006, will compare the effectiveness of the new vaccine to that of Gardasil.

There will be 10,000 participants in the project worldwide.

Research sites are located around the globe to promote diversity among participants, though most sites are in South America and Asia because they are less expensive to manage.

UW researcher Laura Koutsky from the UW School of Public Health was credited for making major contributions to the development of Gardasil, beginning with trials that started in the late 1980s.

The UW research enterprise’s licensing income leapt from $12 million in 2006 to $38 million in 2008 through the collection of royalties for developing and testing the vaccine.

Mao said that Gardasil can prevent about 70 percent of all HPV strains, but it only helps prevent two types of HPV that could cause cervical cancer. The multivalent HPV vaccine currently being tested could help prevent seven types of cancer-causing HPV.

“The vaccine could be 87 to 88 percent effective at preventing … abnormal pap tests,” Mao said.

Costs of treating HPV and cervical cancer could also go down, Mao said, as the vaccine could help avoid costly diagnosis and uncomfortable treatment.

Study coordinator Sandra O’Reilly said participants for the study attend sessions lasting no longer than an hour over a period of three-and-a-half years.

The length of the study does not affect how participants are selected, said Lauren Asaba, a health care specialist at the Women’s Clinic at Hall Health.

However, Asaba does ask during screening sessions if participants could be leaving Seattle during the study period.

Participants are given the vaccine and have exams throughout the study, giving them virtually free gynecological care during the study. Participants of the study will be exposed to HPV, Mao said.

Mao will be looking for signs of cervical dysplasia in order to test the effectiveness of the vaccine.

“If a subject does have an abnormal pap [test], which is an indication of HPV infection, they are seen by Mao, and it is covered by the study,” Asaba said.

 Subscribe to Cervical Cancer News Information Links

Study on cervical cancer vaccine for young men

Madison, WI

Danny and Craig Womack are brothers, and typical college students. They both signed up for a medical study on campus to make a little money. "My brother dragged me into it, definitely, dragged me into it, but being a college student, you know, free easy money for a good cause. It's difficult to pass up," says Craig.

The Womacks are among nearly 4,000 men between the ages of 16 and 26 taking part in an international study to see if the cervical cancer vaccine, Gardasil, can prevent disease in men. Doctor Anna Giuliano is leading the research. "We're so focused on HPV causing cervical cancer that most of us just haven't had the chance to recognize that this infection causes cancer in men. We're talking about 90 percent of anal cancers, 50 to 80 percent of penile cancers and up to 60 percent of oropharyngeal cancers."

HPV is spread through sexual intercourse, so it stands to reason that girls and boys might both benefit from the vaccine. Dr. Giuliano says reducing infection in men would prevent transmission of the infection to females, and ultimately reduce infection all around.

There's more data to crunch before the study concludes, but the vaccine maker is so encouraged, they're already moving forward. Merck Company is applying for approval from the Food and Drug Administration, which could make a ruling by the end of the year. Right now, Gardasil is given to girls in three doses over a six month period. If approved, the same treatment course would apply for men.

The Womacks are encouraged. They're also glad to be taking part in a study that has the potential to educate a whole new generation of young people to the risk of HPV.

 Subscribe to Cervical Cancer News Information Links

QIAGEN focuses new HPV test ad campaign on real-life story of woman's escape from cervical cancer

Germantown, MD

Jodi McKinney, mother of five and wife of nearly 20 years, was recently diagnosed with cervical disease. Fortunately, she was able to be treated before it became cervical cancer -- thanks in part to her physician's decision to order an HPV test along with her Pap. Despite her initially normal Pap smear, the HPV test found that Jodi had a high-risk type of the human papillomavirus -- the primary cause of cervical cancer. Now, Jodi, her entire family and her physician are the focus of a new television campaign launched by QIAGEN to share what Jodi learned about cervical cancer prevention with other women across America. QIAGEN is the developer of the digene HPV Test, the only FDA-approved test for HPV.

View the entire TV ad featuring Jodi McKinney and her family sharing the message about the importance of HPV testing at http://tinyurl.com/4owquc

The ad tells of the scare first experienced by Jodi, her husband Patrick and her five children, and of the happy ending that has allowed Jodi to tell her story today. It is now being broadcast in selected cities across the country. The TV ad can be viewed online as well.

cervical cancer malpractice lawsuits

 Subscribe to Cervical Cancer News Information Links

HPV Vaccine Reduces Abnormal Pap Test Results

Birmingham, AL

A significant drop in abnormal Pap test results was seen after girls and women were given a human papillomavirus (HPV) vaccine to prevent cervical cancer, according to a researcher at the University of Alabama at Birmingham (UAB), Birmingham, Alabama.

These findings, presented on March 10 at the annual meeting of the Society of Gynecological Oncologists in Tampa, Florida, show the HPV vaccine (trade name Gardasil) appears to prevent the development of cell changes that lead to cervical disease. In testing, the vaccine reduced abnormal Pap test results by 43% compared with women not given the vaccine. The 43% reduction was for tests that found precancerous changes called high-grade squamous intraepithelial lesions (HSIL) more than 3 years after women were given the vaccine.

The HPV vaccine also reduced other abnormal Pap results, including milder premalignant cell changes, by 16% to 35% compared with women not given the vaccine. These findings are not definitive that the HPV vaccine prevents cancer; however, they do signal that the vaccine will spare thousands of women a diagnosis of cell abnormality or malignant changes that may lead to more tests and possibly surgery.

"Clearly the vaccine's benefits include something that can be appreciated by women and daughters fairly quickly," said Warner Huh, MD, Associate Professor, UAB Division of Gynecologic Oncology, and the physician chosen to present the data. "This is a positive first sign, and it will take many more years to know definitively if the vaccine prevents cancer."

The results are a compilation of 3 separate trials involving more than 18,000 women aged 16 to 26 years in the United States, Europe, and Asia. All test subjects had normal Pap smear readings at the start of the trial.

misread Pap Test medical malpractice lawyers

 Subscribe to Cervical Cancer News Information Links

Cervical cancer vaccine approval delayed by FDA

December 18, 2007

The Food and Drug Administration dealt a blow to GlaxoSmithKline PLC in delaying approval of one of the company's most important new products: the cervical-cancer vaccine Cervarix.

GlaxoSmithKline said the FDA sent it a so-called complete response letter, which the regulator issues when the review of a drug or vaccine is completed and questions remain to be answered before approval. More >>

Misread Pap Smear Medical Malpractice Attorneys

 Subscribe to Cervical Cancer News Information Links

Targeting the infectious agents behind cancers: Cervical cancer HOV vaccination

December 10, 2007

Possibly as many as a fifth of all forms of cancer are caused by chronic infections, and if vaccine and drug efforts were substantially boosted worldwide, thousands of cancers could be prevented, a leading expert is positing.

Dr. Andrew Dannenberg, director of the Cancer Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in Manhattan, estimates that pathogens underlie anywhere from 15 to 20 percent of cancers affecting people globally.

Many of the infectious agents that can cause cancer are more problematic in poorer countries where vaccine technology is nonexistent and costs to purchase from abroad prohibitive.

The World Health Organization has underscored that the lack of money and poor refrigeration capacities in many underdeveloped countries makes access to the HPV vaccine difficult.

"There are about 450,000 new cases of cervical cancer each year worldwide, and more than 200,000 deaths," Dannenberg said. "We know that HPV 16 and 18 account for 70 percent of all cervical cancers and that the development of the HPV vaccine has led to an opportunity to a prevent primary infection, and prevent cervical cancer.

"In the United States the number of cervical cancers is small. So the use of the vaccine in this country and in Western Europe may have important benefits. But there is a pressing need to be able to provide this type of vaccine in the developing world.

"The vaccine requires refrigeration. If a significant number of lives are to be saved we need one that doesn't require refrigeration," Dannenberg said.

"Currently, you have to give three vaccinations," for the HPV vaccine to be complete, he added. "If that could be reduced to just one vaccination, that would facilitate its use in the developing world." More >>

failure to diagnosis cervical cancer

 Subscribe to Cervical Cancer News Information Links

Reasons Pap Tests Used More Than HPV Tests for Cervical Cancer Screening

USA Today Examines Reasons Pap Tests Used More Than HPV Tests for Cervical Cancer Screening [Nov 02, 2007]

USA Today on Thursday examined the reasons Pap tests remain the top cervical cancer screening tool despite some recent studies that found human papillomavirus tests to be "superior" tools (Rubin, USA Today, 11/1). According to two studies published last month in the New England Journal of Medicine, HPV tests were more accurate than Pap tests in the detection of cervical cancer and precancerous changes in the cervix.

For one of the studies, Canadian researchers led by Eduardo Franco of McGill University performed an HPV test and a Pap test on 10,154 women ages 30 to 69. The HPV test detected 95% of cases in which participants had precancerous changes in the cervix, compared with 55% for the Pap test, the study found (Kaiser Daily Women's Health Policy Report, 10/19).

According to USA Today, about 60 million Pap tests are performed annually in the U.S., and "switching to screening with only an HPV test would represent a sea change in women's health care." The "most obvious roadblock" toward greater HPV testing in the U.S. is that a test manufactured by Digene is the only HPV test approved by FDA, and it is approved only to be used in conjunction with a Pap test or as a follow-up screening, USA Today reports. In addition, a clinical trial to prove that screening with the HPV test will lead to lower mortality rates "might be prohibitively costly and time-consuming," according to USA Today.

Some researchers said that other reasons Pap tests remain the top cervical cancer tool include malpractice concerns, marketing of Pap tests, and reluctance among many physicians and women to not use the Pap tests, according to USA Today. Walter Kinney, a cytologist at Kaiser Permanente in California, said that even if HPV testing were approved as a stand-alone primary screening tool, convincing physicians and patients of its efficacy would be a challenge (USA Today, 11/1).

 Subscribe to Cervical Cancer News Information Links

New Study Shows Listeria Vaccine for Cervical Cancer Found Safe

New Study Shows Listeria Vaccine for Cervical Cancer Found Safe
CNN Money
October 16, 2007: 05:05 AM EST

NORTH BRUNSWICK, N.J., Oct. 16 -- Researchers testing a vaccine based on the live bacteria Listeria, in women with advanced cervical cancer found it to be safe. The Lovaxin C vaccine being developed by Advaxis Inc. , is intended to treat cervical cancer and head and neck cancers that result from the human papilloma virus (HPV). This marked the first time the vaccine had been treated in humans.

"Our long held belief that live Listeria vaccines are safe, even in end stage cancer patients, has been confirmed with the results from our recent Phase I/II study. We have just entered the age of safe bacterial therapies," said Dr. John Rothman, VP of Clinical Development.

The immune response that Listeria generates is called "cellular" immunity, the type needed to attack cancer. Listeria is one of the strongest stimulators of cellular immunity known. "By redirecting it against specific tumor types safely, we have created a new, and potentially very effective, class of cancer therapy," says Rothman. More >>

cervical cancer lawyer

 Subscribe to Cervical Cancer News Information Links

Cervical Cancer Screening: Too Many Are Left Unprotected

Science Daily — The decline in cervical cancer is a success story of cancer research. Although there are reasons to be optimistic about even further decreases in cervical cancer incidence, there still remain some women who are not screened.

A meta-analysis by Spence and colleagues published in Preventive Medicine shows that undergoing Pap smears irregularly or never was the primary explanation for the development of invasive cervical cancer, followed by false negative tests and poor follow-up of abnormal results.

Papanicolaou and Traut first reported the usefulness of the Papanicolaou smear (''Pap test") for detecting neoplastic cervical cells in 1943. A smear of cells of the uterine cervix indicating the progression of the cancer's growing malignity provided a powerful screening tool that became rapidly used after WWII without its efficacy being evaluated in a randomized control trial. In the United States, the Pap test is credited with having halved the annual cervical cancer incidence rate (from 17.2 to 8.0 per 100,000) and mortality rate (from 6.2 to 2.9) from 1973 to 1999.

In 2000, 83% of U.S. women age 18 and older who had not had a hysterectomy reported having had a Pap test within the past 3 years. The recent discovery of a vaccine against human papillomavirus (HPV), the main cause of cervical cancer, opens the way to the primary prevention of the disease.

The natural history of cervical cancer progression combined with the availability of an HPV vaccine and an effective screening test indicate that eradication of the disease is a plausible objective. More >>

Pap Smear Malpractice Lawsuits

 Subscribe to Cervical Cancer News Information Links

Earlier detection of cervical cancer through HPV DNA testing could permit longer screening interval

10.5.07

They conclude: A full cost-effectiveness analysis will help to determine whether primary HPV testing alone is the preferred strategy for primary cervical screening.

By Lancet, [RxPG] Using human papillomavirus (HPV) DNA testing detects the lesions which lead to cervical cancer earlier than do conventional cytological techniques; this earlier detection could allow the screening interval to be extended. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet.

Professor Chris Meijer, VU University Medical Centre, Amsterdam, Holland, and colleagues studied 17155 women aged 29 to 56 years participating in the regular cervical screening programme in the Netherlands. Of these, 8575 were assigned to HPV DNA testing to detect the high-risk types of human papillomavirus which can cause cervical cancer, while 8580 had conventional cytological testing. Five years later both cytological and DNA testing was done in both groups.

While it was already known that HPV DNA testing detects more CIN lesions, it was not clear until now whether or not these lesions were indeed relevant (non-regressive) cancer precursors. The researchers found that more CIN3+ lesions (cervical cancer and its most serious precursor lesions) were detected in the women given HPV DNA testing (68/8575 positive results) compared with the conventional cytological testing group (40/8580). Five years later, fewer women were detected with CIN3+ lesions in the HPV DNA group (24/8413) compared with the cytological testing group (56/8456). Thus, while of the number of patients with CIN3+ lesions detected over the two rounds did not differ between the groups, these lesions were detected earlier in the HPV DNA testing group.

The authors say: Our results show that implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant cervical lesions. On the basis of this data, we suggest that the current screening interval of five years could be extended by at least one year. The extension will be advantageous to women because of a reduction in the lifetime number of screening tests and referrals.

They conclude: A full cost-effectiveness analysis will help to determine whether primary HPV testing alone is the preferred strategy for primary cervical screening.

In an accompanying Comment, Drs Guglielmo Ronco and Nereo Segnan. Unit of Cancer Epidemiology, CPO Piemonte, Torino, Italy say: The much lower risk of CIN3+ lesions seen in women classified as screen-negative in the experimental group than in the control group shows that extended screening intervals will be safe with HPV-DNA testing. They add that such longer intervals will not only reduce the cost of screening but also the burden for women, as well as improving participation, which is crucial since non-participation [in screening] is still the most important reason for later development of cervical cancer in most developed countries.

Cervical Cancer Lawyer

 Subscribe to Cervical Cancer News Information Links