Medical Health Center

CDC, FDA Release Statement Saying HPV Vaccine Gardasil Remains Safe, Effective

Officials from CDC and FDA on Tuesday released a statement that says a review of available information by the two agencies has found that Merck’s human papillomavirus vaccine Gardasil “continues to be safe and effective” for protecting women and girls from a virus that causes cervical cancer, and that its “benefits continue to outweigh its risks,” Reuters reports.

The agencies said they reviewed more than 9,700 reports of health problems following vaccination with Gardasil. As of June 30, 6% of the reviewed cases were deemed serious events, including 20 deaths. The statement said, “There was not a common pattern to the deaths that would suggest they were caused by the vaccine.” In cases where autopsy or other records were available, “the cause of death was explained by factors other than the vaccine,” according to the statement. In addition, data for other serious problems that were reported — including the rare neurological disorder Guillain-Barre Syndrome — “do not currently suggest an association” between the vaccine and patients developing the conditions, FDA and CDC said (Richwine, Reuters, 7/22).

Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women’s Health Policy Report, 7/11).

Report Projects Decline in HPV Infections in Australia

In related news, a study by Australia’s Cancer Council published in the International Journal of Cancer projected that new cases of HPV will decline in the country over the next 18 months because of a high number of teenage girls who have received HPV vaccinations, the West Australian reports (O’Leary, West Australian, 7/23).

The study provides a projection of HPV rates among Australian women since the introduction of the national immunization program, which began in April 2007. The study found that new infections caused by HPV strains 16 and 18 should decrease by more than 50% by 2010 and fall by 92% by 2050. Lead study author Karen Canfell of the Cancer Council New South Wales said the decrease in new infections likely will be attributed to the vaccination of more than 80% of 12- to 13-year-olds in high schools. “This is great news for Australian girls and women, as we can expect the effect on [cervical] cancer rates to be marked,” Canfell said. She added, “But we cannot afford to rest on our laurels. This reduction will only occur if we maintain this high vaccination coverage amongst younger age groups, as it will provide immunity against HPV before girls are exposed to the virus” (AAP/Sydney Morning Herald, 7/23).

Conference on Curbing Cervical Cancer in Africa Opens in Uganda

The second annual international conference on fighting cervical cancer — titled “Stop Cervical Cancer in Africa: Accelerating Access to HPV Vaccines” — opened on Monday in Kampala, Uganda, Uganda’s New Vision reports. About 500,000 women worldwide develop cervical cancer annually, and about 270,000 women die from the disease each year, according to the New Vision. Nearly 85% of cervical cancer cases are in developing countries where access to routine health care is often limited.

In Uganda, 80% of women with cervical cancer are diagnosed with advanced disease that is difficult or impossible to treat, making it the leading cause of cancer-related deaths in the country, the New Vision reports. Emmanuel Mugisha, country director in Uganda for the global health group PATH, said high costs of HPV vaccines and Pap tests have hindered the fight against cervical cancer. “Cervical cancer screening is not yet widely available,” Mugisha said, noting that most of the few health centers in the country that provide such services are located in the capital of Kampala. He added, “The cost makes it hard for women to go for screening, especially when they are not sick.” Mugisha also said that there is a lack of awareness among the population and that voluntary screening still is unpopular in Uganda because the government has not invested in this public health care aspect.

According to Issa Makumbi, the officer in charge of immunization at Uganda’s Ministry of Health, the country plans to implement vaccination of girls ages 10 to 12 with GlaxoSmithKline’s HPV vaccine Cervarix. Although the vaccine is currently now affordable in some developing countries, Makumbi said that some countries have reached deals with pharmaceutical companies to purchase the vaccine at a reduced price (Nabusoba, New Vision, 7/21). Cervarix also has been shown to be 100% effective in preventing infection with HPV strains 16 and 18 (Daily Women’s Health Policy Report, 7/2).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

View drug information on Gardasil.

Novel Structure Proteins Could Play A Role In Apoptosis

Isoforms from Novel Structure Proteins (NSP), a new family of genes discovered by researchers in the Sbarro Institute for Cancer Research and Molecular Medicine in Temple University’s College of Science and Technology, could be involved in apoptosis or programmed cell death.

NSPs were discovered four years ago by Nianli Sang, then a doctoral student at the University and now an assistant professor at Thomas Jefferson University and the Cardeza Foundation, and Antonio Giordano, director of the Sbarro Institute (http://www.shro.org/) at Temple.

The researchers noted at that time that this family of genes sits mostly in the nucleus of our cells and exhibits the characteristics of a tumor-promoting gene. One form of the gene, the isoform NSP5a3a, is highly expressed in some tumor cell lines and could be very useful as a tumor marker, Giordano said. A protein isoform is a version of a protein with only small differences to another isoform of the same protein.

In the latest study, “Possible Functional Roles of NSPs in Cancer,” published in Cell Cycle (Vol. 7, Iss. 12), the Temple researchers examined the gene in Hela cells, or cervical cancer cell lines, to further characterize the possible role of these NSPs.

“So far, we’ve been able to confirm that two of the NSPs’ four isoforms, called NSP 5a3a and NSP 5a3b, interact with a protein called B23, a multifunctional protein that is involved in cellular processes such as cell division, DNA repair and apoptosis,” said Luca D’Agostino, a research fellow in the Sbarro Institute and the study’s lead author.

In the study, the researchers silenced the expression first of NSP 5a3a. They also did the same for B23, and both in combination, always in-vitro.

“We saw that when we lowered the expression of NSP 5a3a, the cell’s viability was not affected and they continued proliferating,” D’Agostino said. “They must have a mechanism to compensate for its absence.”

But when the expression of B23 was lowered, most of the cells moved towards apoptosis, which has already been established in previous studies, he said.

When the expression of both proteins was lowered simultaneously, D’Agostino noted, no apoptosis occurred, leading the researchers to conclude that at least in this model of in-vitro Hela cells, NSP 5a3a, working in association with B23, may have a role in apoptosis.

“Since these NSP isoforms have similar structural characteristics of known structural proteins such as spectrins, they may act as scaffolding proteins to help B23 interact with whoever it needs to interact with inside the cells,” he said. A spectrin is a cytoskeletal protein that lines the intracellular side of the plasma membrane of many cell types in pentagonal or hexagonal arrangements, forming scaffolding that plays an important role in maintenance of plasma membrane integrity and cytoskeletal structure.

D’Agostino said the next step for researchers is to examine exactly how the NSP isoforms are interacting with the B23 protein. “We have an idea, but we still have to confirm it,” he said.

D’Agostino added that these NSP isoforms may also have diagnostic value.

“Eventually, we have to screen different types of cancers, different grades and stages, to see if there is a difference in the expression of NSP5a3a and 5a3b, and if they have an application in the clinical field,” he said. “With the 5a3a, if we see a pattern of expression when we do screenings of tissue biopsies, it could be useful as a diagnostic tool.”

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Article adapted by Medical News Today from original press release.
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This research was funded through grants from the Sbarro Health Research Organization and National Institutes of Health.

Source: Preston M. Moretz
Temple University

University Of Iowa To Begin Using LUMA(R) Cervical Pre Cancer Imaging Device

SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego-based medical devices company, announced that it has placed its LUMA Cervical Imaging System to detect pre-cancers at the University of Iowa in Iowa City, Iowa under the direction of Dr. Colleen Kennedy.

Dr. Kennedy stated, “We are indebted to the John and Mary Pappajohn Cancer Center Fund for their generous donation allowing us to implement the LUMA system at the University of Iowa. We look forward to benefiting from the enhanced productivity that it provides and, more importantly, for the ability to provide better patient care and outcomes. We are the only medical center currently in the mid-west providing this state-of-the art technology.”

The LUMA Cervical Imaging System was developed to significantly improve the detection of high-grade precancerous cervical abnormalities that have the potential to become invasive cancer. Based on data from the National ALTS study, it is estimated that precancerous disease goes undiagnosed in about 200,000 women each year.

The LUMA System provides a safe and effective method, that when used as an adjunct to colposcopy, has been demonstrated to uncover at least 26% more high-grade precancerous disease than colposcopy alone. The latter is the current gold standard following an abnormal Pap test.

SpectraScience CEO Jim Hitchin commented, “We are pleased to have placed our LUMA System at the prestigious University of Iowa facility and believe that it is a strong validation of our technology. We are committed to developing and bringing more effective cancer screening technologies to the market with the result of better and earlier diagnosis.”

Management estimates that the there are more than 2 million procedures performed annually at more than 1,600 sites throughout the U.S. The University of Iowa performs approximately 1,300 procedures annually.

SpectraScience has filed for 60 patents worldwide on its WavSTAT(R) Optical Biopsy System and LUMA Cervical Cancer Imaging System that are used to diagnose tissue to determine within seconds if it is normal, pre-cancerous, or cancerous. The WavSTAT and LUMA systems are currently approved by the FDA for detecting pre-cancer and cancer in the colon and cervix, and an evaluation for detection of pre-cancers in the throat (”Barrett’s esophagus”) is being tested.

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve risks and uncertainties that may cause SpectraScience’s actual results to differ materially from results discussed in forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by SpectraScience in this news release, its most recent Form 10-K and in SpectraScience’s other reports filed with the Securities and Exchange Commission (”SEC”) that attempt to advise interested parties of the risks and factors that may affect SpectraScience’s business. These forward- looking statements are qualified in their entirety by the cautions and risk factors filed by SpectraScience in its annual report on Form 10-K and other documents.

About University of Iowa Healthcare

University of Iowa Health Care is a fully integrated academic medical center, uniting the UI Roy J. and Lucille A. Carver College of Medicine, University of Iowa Hospitals and Clinics, and UI Physicians, the largest multi-specialty group practice in Iowa. As the state’s premier academic medical center, UI Health Care provides high quality, patient-centered care, conducts groundbreaking biomedical research, and educates the scientists and health care providers of the future.

About SpectraScience, Inc.

SpectraScience is a San Diego based medical device company that designs, develops, manufactures and markets spectrophotometry systems capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body. The WavSTAT Optical Biopsy System uses light to optically scan tissue and provide the physician with an immediate analysis. With FDA approval for sale in the U.S. and the CE Mark for the European Union, the WavSTAT System is the first commercially available product that incorporates this innovative technology for clinical use. The Company’s LUMA imaging technology has received FDA approval for an optical non-invasive system that is proven to more effectively detect cervical cancer precursors than conventional methods available in the market.

SpectraScience, Inc.
http://www.spectrascience.com

Merck Responds To Questions About Adverse Events Reported Following Vaccination With GARDASIL®

Merck issued the following statement to address questions about adverse events reported in people who had received GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant].

Merck has analyzed the adverse events reported for GARDASIL relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population, even in the absence of vaccination. An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event. The vast majority of adverse events that have been reported to Merck are non-serious and the most common include dizziness and syncope (fainting).

“Merck is proud of the public health benefit that GARDASIL can provide in helping to prevent cervical cancer and other HPV diseases caused by HPV types 6, 11, 16 and 18 throughout the world and we remain confident in the safety profile of GARDASIL,” said Richard M. Haupt, executive director, Clinical Research, Merck Research Laboratories. “Merck encourages health care providers and consumers to report any adverse experience associated with GARDASIL to the Company and to the U.S. Vaccine Adverse Event Reporting System so that the Company can continue to thoroughly monitor the safety of this important vaccine.”

Merck continues to evaluate all safety data in the context of its own post-marketing adverse experience database as well as its ongoing clinical trial database and provides post-marketing reports to regulatory authorities worldwide. For vaccines, Merck also participates in the U.S. Food and Drug Administration and Centers for Disease Control and Prevention adverse event reporting system that collects data on any adverse event following vaccination, whether coincidental or potentially caused by a vaccine.

The labeling for GARDASIL reflects the extensive data available from our clinical trials of more than 25,000 people and Merck updates its product labels with new safety information as appropriate. As of March 31, Merck has distributed more than 26 million doses of GARDASIL worldwide, nearly 16 million of them in the U.S., since approval in June 2006.

In 2006, GARDASIL became the only approved vaccine to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18 in girls and women 9 through 26 years of age. GARDASIL (sold in some countries as SILGARD®) has been approved in 103 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

Additional important information aboutGARDASIL

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. GARDASIL is not recommended for use in pregnant women.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts, cervical cancer, CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL has not been shown to protect against disease due to other HPV types.

In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Other Information about GARDASIL

In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA.

View drug information on Gardasil.

Merck, FDA Update Potential Adverse Reactions To HPV Vaccine Gardasil, Washington Times Reports

The Washington Times on Thursday reported that Merck and FDA last month added potential adverse reactions to Merck’s human papillomavirus vaccine Gardasil to the package insert and information sheet given to patients. The potential adverse reactions include joint and muscle pain, fatigue, physical weakness and “general malaise,” according to the Times.

According to a report released last month by the conservative, nonpartisan group Judicial Watch, a government database had received 8,864 reports of potential adverse events as of June 10 from the vaccine since FDA approved it in 2006. CDC spokesperson Curtis Allen said government and Merck officials look at all reports of adverse events to look for patterns, adding, “From the data we have seen to date, the vaccine is safe and effective.”

FDA spokesperson Karen Riley said that the updated information on potential adverse reactions has “nothing to do” with reports of possible serious reactions to the vaccine, adding that the update was made at Merck’s request to address potential “mild” symptoms. “The bottom line is that we have not seen any safety signals in the adverse events other than” fainting, Riley said, adding, “We continue to look at these reports.” Merck spokesperson Amy Rose said that she does not have “any reason to believe” the changes are “anything other than a routine update.” Tom Fitton, president of Judicial Watch, said that the group is “not convinced” that the government is “taking these reports seriously” and is calling for “further investigation of its safety” (Washington Times, 7/10).

According to Merck, 11,000 girls and women received the vaccine before it was approved, and 16 million doses have been distributed in the U.S. since approval (Fagan, Washington Times, 7/10). Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women’s Health Policy Report, 7/8).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

View drug information on Gardasil.

GlaxoSmithKline Responds To FDA On Cervarix® And Plans To Submit Final Study Data For Approval

GlaxoSmithKline provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of Cervarix®, its vaccine to prevent cervical cancer.

GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK’s Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these datain the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.

“Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “We continue to have positive and productive discussions with the FDA and remain confident in the vaccine’s safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S.”

To date, GSK’s cervical cancer vaccine has been approved in 67 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

Burden of cervical cancer

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.1 In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.2

About GlaxoSmithKline

GlaxoSmithKline one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems. The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines an average of 3 million doses a day.

Cervarix® is a registered trademark of the GlaxoSmithKline group of companies

GSK cautionary statement regarding forward-looking statements

Under the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2007.

References:

1. World Health Organization. Initiative for Vaccine Research. Accessed on May 2, 2007.

2. Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005. Cancer Journal for Clinicians 2005; 55; 10-30

GlaxoSmithKline
http://www.gsk.com

HPV Vaccine Gardasil Under Investigation For Adverse Events, New York Post Reports

Lawyers for two girls who received Merck’s human papillomavirus vaccine Gardasil last month filed the first two claims under the federal Vaccine Injury Compensation Program, the New York Post reports.

One of the girls, Jesalee Parsons of Oklahoma, developed pancreatitis shortly after receiving the vaccine, according to her claim. The other girl, Jessica Vega of Nevada, claims that she developed the immune condition Guillain-Barre Syndrome one week after receiving the second of Gardasil’s three doses. According to the Post, Gardasil was added to the list of vaccines that are protected from lawsuits under a 1980s law. However, people can receive compensation under the Vaccine Injury Compensation Program if they can prove a vaccine likely caused a condition.

According to the Post, federal health officials have reported nearly 8,000 “adverse events” in girls and women who have received the vaccination, and officials are investigating claims that the vaccine caused serious health problems and 18 deaths in the U.S. John Iskander, CDC’s acting director for immunization safety, said a review of 10 confirmed deaths allegedly linked to Gardasil found no common thread. He said that officials “concluded to the degree of certainty possible” that Gardasil was not the cause of the deaths. Iskander said physicians hold special meetings weekly to review new cases and compare them with prior cases.

According to Merck, the vaccine has been given to more than eight million girls and women in the U.S. since FDA approved it two years ago (Edelman/Golding, New York Post, 7/6). The vaccine in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women’s Health Policy Report, 3/21).

Kelley Dougherty, a Merck spokesperson, said the company “actively monitors” reports of Gardasil’s side effects. Dougherty added, “An event report does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination” (New York Post, 7/6).

CBS’ “Evening News” on Monday reported on adverse event reports related to Gardasil (Attkisson, “Evening News,” CBS, 7/7).

CNN’s “Newsroom” on Monday also reported on the adverse event reports. The segment includes comments from CNN medical correspondent Elizabeth Cohen (Phillips, “Newsroom,” CNN, 7/7).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

View drug information on Gardasil.

Sex During Adolescence Doesn’t Predict Future HPV Infection

Predicting a child’s future is a near impossible task - today’s straight-A student may not become tomorrow’s doctor, and the school-yard bully may actually grow up to become a member of the Peace Corps.

So why should an adolescent’s sexual behavior- or lack thereof - determine whether or not she gets vaccinated against the human papillomavirus, to protect against future HPV infection? It shouldn’t, say researchers at the University of Michigan C.S. Mott Children’s Hospital’s Child Health Evaluation and Research (CHEAR) Unit.

The study, set to appear in the July issue of the journal Pediatrics, finds women who were sexually active as adolescents were just as likely as women who were not sexually active during their youth to get HPV as adults.

“Using risk factors as a means to determine who should get the HPV vaccine is not a good strategy. In our study, all women who eventually became sexually active at some point had an equivalent risk of getting HPV,” says study lead author Amanda F. Dempsey, M.D., Ph.D., MPH, a member of the CHEAR Unit in the U-M Division of General Pediatrics.

These findings, Dempsey says, support the Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices recommendation for universal vaccination for all women ages 11 to 26, regardless of sexual experience.

Much of the confusion over whether or not to vaccinate a patient stems from conflicting recommendations. While the ACIP advocates for universal vaccination, the American Cancer Society recommends vaccinating all females younger than 18, and selectively vaccinating women ages 19 to 26 based on an informed discussion between the patient and her doctor about sexual history.

The price of the vaccine is also a factor. With each dose costing approximately $120 - along with high up-front costs to stock the vaccine, inconsistent coverage from government programs and low levels of reimbursement from private insurance - many states are struggling to provide the vaccine to all eligible girls and women.

For those reasons, many clinicians are targeting the HPV catch-up vaccination to only girls and women they deem to be at the greatest risk for acquiring HPV. Previous studies of sexually active adolescents and young adults identified specific sexual partnerships, behavioral and sociodemogrpahic characteristics associated with increased risk for HPV infection.

The problem, Dempsey says, is that those studies only looked at women currently infected with HPV, and retrospectively analyzed potential risk factors for infection.

“Few studies have evaluated the ability of specific risk factors to predict future HPV infection prospectively,” says Dempsey. “This is an important distinction, given that, to be effective, the HPV vaccine must be provided before vaccine type-specific infection occurs.”

For their study, Dempsey and her colleagues selected six high-risk behaviors that have been shown in other studies to be associated for sexually active women with a higher risk of HPV - the number of sexual partners, history of having an older male sexual partners and/or a new sex partner with the past year, illegal drug use, history of sex while impaired by drinking, and regular use of cigarettes/alcohol. For virgins the team also assessed risk factors found in other studies to be associated with the acquisition of other sexually transmitted diseases, and early sexual activity.

Of the risk factors evaluated during adolescence, none were found to be associated with future HPV infection. Among sexually active adolescents, only a history of having sex while impaired by alcohol was associated with increased odds of testing positive for vaccine-type HPV as a young adult.

“Whether or not an adolescent was sexually active did not have an association with future HPV infection,” says Dempsey. “Essentially all individuals who become sexually active are at risk for acquiring HPV, which is due to the high prevalence of HPV in society. So targeting particular groups for vaccination would prevent many at-risk women from being protected.”

In fact, estimates suggest that more than 80 percent of the U.S. population will have had an HPV infection by the time they reach the age of 50.

The study also found:

- Of the 3,181 study participants, 43 percent reported being sexually active in the first wave of the study. The first wave included girls ages 11-17.

- Virgins with a history of illegal drug were at a decreased risk for young-adult HPV infection.

- Sexually active adolescents tended to be older, in a higher grade and were more likely to be African American.

- 53 percent of study participants, who tested positive for HPV in the third wave of the study (ages 18 and older), were virgins in the first wave of the study.

HPV infection generally occurs shortly after a woman becomes sexually active. Most women never know they have the virus because it usually goes away on its own and may not cause any symptoms. There are more than 100 types of HPV, but only some types of HPV lead to cervical cancer or genital warts. The vaccine guards against four types of HPV: two that cause 70 out of 100 cases of cervical cancer and two that cause 90 out of 100 cases of genital warts.

In addition to Dempsey, study co-authors were Achamyeleh Gebremariam, with the CHEAR Unit in the Department of Pediatrics at the U-M Health System; and from the Department of Epidemiology at the University of Washington, Laura A. Koutsky and Lisa Manhart.

The study was supported in part by the 2007 Ambulatory Pediatric Association Young Investigator Grant program.

Reference: Pediatrics, July 2008, Vol. 122, No. 1.

University of Michigan Health System

The Changing Landscape For Cervical Screening

Cervical cancer screening needs to take into account a partially-vaccinated population and new technologies, according to an editorial published in the latest edition of Medical Journal of Australia.

Dr Annabelle Farnsworth, from Douglass Hanly Moir Pathology, said that although Australia has an enviable record in the control of cervical cancer, there are real benefits in incorporating new knowledge and associated technologies into screening and management of the disease.

“A national, well-funded and organised program of screening using the conventional Pap Smear has significantly reduced the incidence and mortality rates of cervical cancer in Australia,” she said.

Dr Farnsworth said that there has been much discussion overseas about replacing cervical cytology tests with human papillomavirus (HPV) tests for primary screening.

“Currently, there is no justification for this as HPV testing is highly sensitive but not specific.

“HPV testing may have a greater role in the management of indeterminate abnormalities detected by cervical cytology tests.

“Both HPV tests and ThinPrep imaging [a newer type of cytology test] are more expensive than conventional cytology, but they could be cost-effective if used appropriately in conjunction with a comprehensive review of the cervical screening program,” she said.

Dr Farnsworth said that in addition to the new screening techniques, a national program of vaccination against two of the 15 oncogenic viruses began in April last year.

“Pharmaceutical Benefits Advisory Committee commented that there would be cost savings if vaccination fully replaced cervical screening but the cervical cancer life-time risk would increase to 1.173 per cent.

“The recommendation therefore is that screening must continue after vaccination. The screening interval and screening test for vaccinated women should be different to those for unvaccinated women and should be determined by population-based research over the next 5-10 years.”

The Medical Journal of Australia is a publication of the Australian Medical Association.
The statements or opinions that are expressed in the MJA reflect the views of the authors and do not represent the official policy of the AMA unless that is so stated.

Medical Journal of Australia

GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009

GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval. The study results likely will be submitted to FDA in the first half of 2009, with an FDA decision expected no more than six months later. GSK is competing with Merck for HPV vaccination contracts around the world (Hirschler, Reuters, 6/30).

Cervarix and Merck’s FDA-approved vaccine Gardasil in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases (Daily Women’s Health Policy Report, 6/20). Both vaccines are designed to be given to girls and young women but have different properties (Reuters, 6/30). According to Reuters, Cervarix uses a “novel adjuvant,” or additive, that GSK says makes it longer lasting. Cervarix has been approved in 67 countries, including Australia, European Union countries and Mexico (Debreczeni, Dow Jones, 6/30).

FDA in December 2007 requested additional information about the vaccine before issuing a decision on GSK’s application for Cervarix (Deighton, Thomson Financial/Forbes, 6/30). GSK CEO Jean-Pierre Garnier in February said that the company will provide FDA with the requested information by the third quarter of 2008 (Daily Women’s Health Policy Report, 4/11). The company said it decided to wait until the results from the Phase III trial are available because it expects the trial to find a longer duration of safety and efficacy, according to Thomson Financial/Forbes (Thompson Financial/Forbes, 6/30).

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