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

Older Women Are Not Likely to Benefit From Cervical Cancer Vaccine

New York, NY

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

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

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

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

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Free cervical cancer vaccine funding received by Costal Health District in Georgia

Health department to offer free HPV vaccine for some women in Georgia

Savannah, GA

The Coastal Health District has received funding to provide the human papillomavirus vaccine, also known as Gardasil, free of charge to women who meet certain criteria.

The HPV vaccine is a safe and effective vaccine developed to prevent cervical cancer.

To qualify for the program, women must be 19 to 26 years of age, not pregnant and have Medicaid, Medicare, no health insurance or health insurance that does not cover the cost of HPV vaccine.

The vaccine is given in a series of three doses. It is important women who receive the vaccine get all three doses in order to obtain maximum protection from HPV.

Women who meet the criteria and have not yet started the series are eligible to receive the vaccine under this program. In addition, women who already have received one or two of the doses are eligible to complete the series under this program.

Cervical cancer is caused by certain types of HPV, and an estimated eight out of 10 women will become infected with HPV in their lifetime.

"We are thrilled to be able to offer the HPV vaccine at no charge to women who qualify for this program," said Marianne Pappas, Coastal Health District immunization coordinator. "When a woman gets the HPV vaccine, she significantly lowers her chance of getting cervical cancer. But until now, many women couldn't afford to get the vaccine."

An administrative fee of $14 will be charged for each dose. However, no one will be denied because of inability to pay. Normal cost of the vaccine is about $160 per dose. The program runs through September.

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HPV infects 56% of young lovers, new study finds

Montreal, Canada

A groundbreaking study of young Canadian couples in new sexual relationships has found that more than half -- 56% -- are infected with the human papilomavirus.

Of that group, 44% had the type of HPV that causes cancer of the cervix and penis.

"Our study is the first to investigate HPV transmission in a large number of new couples among young adults," Dr. François Coutlée, a researcher at the Centre Hospitalier de l'Université de Montréal where the HPV tests were analyzed, said in a news release. "The results suggest that many HPV transmissions occur at the start of new relationships, which reinforces the need for prevention."

The study's coordinator said researchers weren't surprised by their findings.

"It is a high number, but that number was not entirely unexpected," Ann Burchell, a post-doctoral fellow at McGill University's cancer epidemiology unit, told the CanWest News Service. "We know that HPV is a very common infection already, particularly in young people. We know that people are at a high risk of getting HPV just after acquiring a new partner."

HPV infections are common: more than 70% of women and men will be infected at some point. But the vast majority of people experience no symptoms, and the infection lasts between one and two years. Of women infected with HPV, fewer than 1% will develop cervical cancer.

The findings were published in the January issues of Epidemiology and Sexually Transmitted Diseases.

In October, the U.S. Centers for Disease Control and Prevention recommended that all girls ages 11 or 12 be given the HPV vaccine, Gardasil.

Two months earlier, the CDC reported that the vaccine was linked to 32 unconfirmed deaths and showed higher incidences of fainting and blood clots than other vaccines. That concerned some doctors and parents. Others were reassured by the report, noting that its side effects were neither more unusual nor more serious than other vaccines.

The CDC addresses health concerns about the vaccine.

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Merck submits (cervical cancer HPV vaccine) Gardasil data for women 27 to 45

New York, NY

Merck & Co on Wednesday said it had provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.

Gardasil, one of Merck's biggest products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. It works by preventing infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.

The U.S. Food and Drug Administration early last year again withheld approval for its use by women aged 27 to 45, asking the drugmaker to submit data when a 48-month study on a test group has been completed.

Merck, in a statement on its Web site, said it had provided the completed trial data to the FDA before the end of 2009. The company said the FDA typically takes six months to review such responses.

Global sales of Gardasil fell 22 percent to $311 million in the third quarter, hurt by overseas competition from GlaxoSmithKline's rival Cervarix vaccine and continuing delays in winning expanded approval for the product.

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

Ann Arbor, MI

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

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

These are Dr. Dempsey’s results verbatim:

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

The study found:

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

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

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

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

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

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

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

Helsinki, Finland

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

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

Key research findings

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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CDC advisory committee recommends Cervarix HPV vaccine for girls, young women to prevent cervical cancer

Philadelphia, PA

GlaxoSmithKline
announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommended that CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] be given to girls and young women to protect against cervical pre-cancers and cervical cancer caused by oncogenic HPV 16 and 18. The ACIP specifically recommended CERVARIX for routine administration among 11 and 12 year old girls. In addition, the recommendation includes a catch up for girls and young women who have not previously been vaccinated, which for the approved age range for CERVARIX includes 13-25 year old girls and young women.

On October 16, 2009, the Food and Drug Administration (FDA) approved CERVARIX for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

"It's estimated that this year, ten women will die every day from cervical cancer in the U.S.," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "The ACIP recommendation for CERVARIX underscores how important it is for girls and young women to be vaccinated to help reduce the burden of this devastating cancer."

Additionally, the ACIP unanimously recommended to provide funding for CERVARIX from the Vaccines for Children (VFC) program. The federally funded program provides vaccines at no cost to children up through 18 years of age who might not otherwise be vaccinated because of inability to pay. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the ACIP.

CERVARIX is expected to be commercially available in the U.S. in late 2009.

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Cervical cancer vaccine Cervarix wins support from Japan Health Ministry panel

Tokyo, Japan

GlaxoSmithKline (GSK.L) won support for its cervical cancer vaccine from an advisory panel to Japan's Health Ministry on Tuesday, putting it on track to be the first to offer such a vaccine in the world's second-biggest drug market.

The ministry should give its final stamp of approval within a month, said Takehiro Kimura, a health ministry official.

On Monday, British health officials said a teenage girl died after receiving a cervical cancer vaccine made by Glaxo, though no link could be made between the death and the drug until all facts were known and a post-mortem conducted. [ID:nLT165573]

Approval in Japan could help clear the way for Merck & Co (MRK.N), which has also applied for approval for its Gardasil vaccine. Both Glaxo's Cervarix and Merck's Gardasil vaccines protect against infection from the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

About 2,500 women die each year in Japan from cervical cancer. Worldwide deaths from the disease total about 280,000, mostly in developing countries with inadequate screening.

Glaxo's Cervarix has already been approved in 98 countries, with sales in January-June nearly matching its annual sales of 125 million pounds ($199 million) last year.

A U.S. panel has also backed the vaccine for approval and a final decision could come this month, though Cervarix's launch in the world's largest drug market will lag Gardasil, which won approval three years ago. [ID:nN09323683]

Merck's Gardasil vaccine has been approved for use in 112 countries, and logged $1.4 billion in sales in 2008.

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Doctors on cervical cancer vaccine Garaisil: Benefts outweigh costs

Minneapolis, MN

The new vaccine designed to protect girls and young women from cervical cancer has a safety record that appears to be in line with that of other vaccines, a new government report found. Some serious complications were reported -- including 32 deaths and two cases of Lou Gehrig's disease -- but there is no way to prove they were produced by the vaccine, which has been given to 7 million girls and young women during its first years on the market.

The most common serious complications after vaccination with Gardasil were fainting episodes and an increased risk for potentially fatal blood clots, possibly related to oral contraceptive use and obesity, the study found.

But while the tone of the study, published in the Journal of the American Medical Association, was reassuring, the authors noted that the analysis was based on imperfect data drawn from voluntary reports.

"We feel confident recommending people get the vaccine; the benefits still outweigh the risks," said Dr. Barbara A. Slade, of the Centers for Disease Control and Prevention, which did the study together with the Food and Drug Administration.

Nevertheless, an accompanying editorial questioned whether any level of risk is acceptable when inoculating a healthy population against a disease that can be prevented through screening and preemptive treatment.

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Safety concerns about Gardasil HPV vaccine continue

Kansas City, MO

Since the introduction of Gardasil HPV vaccine, the FDA has reported forty seven deaths. Gardasil was approved in 2007. Cervical cancer is caused by HPV (human papillomavirus) and is easily spread. Adverse events from Gardasil in 2008 totaled 6,273, and 147 were reported at “life threatening”.



The report comes from Judicial Watch, a public interest group that monitors government corruption, obtained from the FDA. According to President Tom Fitton, "The already serious problems associated with Gardasil seem to be getting worse. No one should require this vaccine for young children."

Adverse events associated with Gardasil vaccine include cervical cancer that developed fifteen months after receiving the HPV vaccine, Guillain- Barre Syndrome after the second vaccine was given, and the death of a nineteen year old girl eleven days after receiving HPV vaccine.

The following is extracted from the FDA report: "After receiving her second dose of GARDASIL … she could crawl but … needed to use crutches or a wheel chair ... She was experienced problems breathing and had ‘super migraines' that never went away … She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice … patient has not recovered from symptoms." Twenty nine new cases of Guillain-Barre syndrome have been seen since June 2008 in association with HPV vaccine.

Among pregnant women, 147 women who received Gardasil experienced spontaneous abortion. Genital warts developed 62 girls after the vaccine was given, appearing in other parts of the body including the hands, face and feet. One girl developed warts all over her body.

Forty one deaths occurred within one month, reported in association with Gardasil, and of those, seventeen occurred within two weeks. The cause of death is still not known.

Fitton says, "The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied."

Concerns about the safety of Gardasil are not new. This year the manufacturer asked the FDA for approval of the vaccine for use in young males. The FDA is considering approval So far, twenty five percent of young women, age 9 to 26 have been vaccinated.

A mathematical study, published last year in the New England Journal of Medicine, suggested that vaccinating young women with Gardasil would be less cost effective than screening programs for cervical cancer. The cost of receiving HPV vaccine ranges from $500 to $900, and may not be covered by insurance.

Merck, the manufacturer of Gardasil responded to initial concerns about adverse events with the following statement: "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."

An article published July 2008 about Gardasil safety concerns disappeared from Medscape after editorial review, and was replaced with more positive findings. You can read the original, article titled ”HPV Vaccine Adverse Events Worrisome Says Key Investigator” at Beyond Conformity. The article was replaced with “HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events”, and can be viewed here.

Gardasil vaccine continues to raise concerns. The medical community voiced those concerns last year, but the manufacturer of the vaccine assured the public the vaccine is safe. Judicial Watch is encouraging public health officials to step back and take a closer look at the safety concerns, and growing number of adverse events associated with Gardasil.

Diane Harper, MD, professor of community and family medicine/obstetrics and gynecology at Dartmouth Medical School, in Hanover, New Hampshire, and director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center took part in the Gardasil clinical trials. Dr. Harper advised last year, "if you are at all concerned, then don't have the vaccine — have regular Pap smears and you will be equally protected from cervical cancer."

Escalating reports of Gardasil side effects and safety will continue to raise concerns. No one knows the long term outcomes of the Gardasil vaccine. The message to all women is, engage in regular visits to your gynecologist for cervical cancer screening. Please share your views or personal experience.

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Cervical cancer vaccine not just for teens

Denver, CO

The human papillomavirus (HPV) vaccine works for women aged 24 to 45 who aren't already infected by HPV, the virus that has been linked to cervical cancer and other cervical diseases.

That's the finding from Dr. Nubia Munoz, of the National Institute of Cancer in Bogota, Columbia, who noted that women's rising age at first marriage and increasing divorce rates have led to more widespread premarital intercourse and pairing with new sexual partners around middle age.

Their study included more than 3,200 women, aged 24 to 45, with no history of cervical disease or cancer or genital warts caused by HPV types 6, 11, 16 and 18. The women received either the quadrivalent HPV vaccine, which protects against the four HPV types, or a placebo at day one and months two and six of the study.

The women were followed for about 2.2 years and the researchers identified four cases of infection or disease in the vaccinated group, compared to 41 cases in the placebo group. That means the vaccine was 91 percent effective against all four virus strains.

When they looked at only HPV types 16 and 18, the researchers found four cases in the vaccine group and 23 in the placebo group, which means the vaccine was 83 percent effective against those two HPV types.

"Lower effectiveness [about 30 percent] detected in the mixed population (susceptible women and those who have already acquired HPV infection or HPV-associated disease) suggests that the public health effect of vaccinating women aged 25 to 45 years will be smaller than that recorded after vaccinating susceptible adolescents. This notion will be assessed in future cost-benefit analyses," the study authors wrote.

The findings appear online June 2 and in an upcoming print issue of The Lancet.

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Broad-spectrum cervical cancer vaccine shows promise

New York, NY

An investigational broad-spectrum cervical cancer vaccine induced strong immune responses in mice and rabbits, and protected them against human papillomavirus (HPV) type 16 for four months, new research has found.

Current HPV L1-based vaccines provide almost 100 percent protection against the two types of HPV that cause 70 percent of all cervical cancer cases worldwide, but they are expensive and offer only limited protection against other HPV types that cause cancer, according to the researchers. The new vaccine may help cover that gap in protection, they noted.

When the candidate vaccine was used with a substance such as alum to stimulate immune response, the animals were protected against infection by HPV type 16, the study found.

"Clinical studies are warranted" to assess the safety of these types of vaccines, wrote Richard Roden, of the Johns Hopkins University in Baltimore, and colleagues. If this new type of vaccine proves effective, "its simpler manufacturing process could make the local production of such a vaccine highly feasible, which might achieve the goal of producing it at sustainable prices in emerging countries and lead to its widespread implementation in the developing world," the researchers said.

The study appears online Tuesday in the Journal of the National Cancer Institute.

A broad-spectrum HPV vaccine could solve the shortcomings of current vaccines -- they're too expensive to be used in much of the world and they don't protect against enough HPV types -- Dr. F. Xavier Bosch, of the Catalan Institute of Oncology in Barcelona, Spain, wrote in an accompanying editorial.

The results of this study "open the door to a novel family of second generation HPV vaccines with significant potential value in the public health horizon. As soon as appropriate, Phase 1 trials in humans should be initiated," Bosch wrote.

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Glaxo's cervical cancer vaccine faces US battle

Trenton, NJ

New studies show GlaxoSmithKline PLC's vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years.

Cervarix, Glaxo's vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil's maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006.

Late in 2007, the Food and Drug Administration declined to approve approve Cervarix. GlaxoSmithKline submitted a new application on March 30 that included final data from an 18,000-woman study recently completed.

Final results from that study and two others are being presented this weekend at a conference in Sweden on papillomavirus. FDA is expected to decide whether to approve Cervarix within several months.

If it does, analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said doctors who have prescribed Gardasil for a few years may see no reason to switch -- unless GlaxoSmithKline convinces them its product is much more effective or has fewer side effects.

Both vaccines target the two types of HPV that cause about 70 percent of cervical cancers, types 16 and 18, and data indicate both are about 98 percent effective. But Merck also has data showing Gardasil blocks two other HPV types that cause most cases of genital warts that Cervarix does not target.

That will be a key factor for doctors, experts said.

"All else being equal, it's a no-brainer for the doctor, (who) wants to give the most efficacious treatment," Gordon said.

Gardasil racked up only $426 million in global sales in the most recent quarter, versus $69 million for Cervarix, which has won more contracts from government health programs in other countries.

Partial results of the new Cervarix studies released to The Associated Press indicate it also offers good protection against 12 other HPV types.

One of the studies, which looked at looked at levels of antibodies to some HPV types after study participants were vaccinated with Cervarix or Gardasil, found higher antibody levels induced by Cervarix. But Dr. Gary Dubin, head of one of Glaxo's clinical development centers, said that doesn't prove Cervarix is more effective.

New data will be presented at the same conference on Gardasil, indicating it blocks HPV 16 for at least 9 1/2 years, according to Merck. Glaxo has followed women for up to 7 1/2 years and continues to test some to see if they develop cervical lesions or cancer.

Dr. Cynthia Rand, a researcher, pediatrician and associate professor at the University of Rochester Medical School, said Cervarix appears to be effective. But she said the higher antibody levels triggered by Cervarix, compared with Gardasil, might be meaningless. She said doctors don't know if they will have to give booster shots years from now for either vaccine.

"It won't change my practice" of giving Gardasil and likely won't do so for other doctors, said Rand, whose university has patent claims and receives some royalties related to both vaccines. "Pediatricians prefer in general to also protect against genital warts."

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Lack of education makes silent HPV virus a real threat

Law Vegas, NV

HPV is sexually transmitted and causes cancer, may be prevented

Even if you think you’re safe, education about human Human Papillomavirus is crucial.

HPV affects both females and males and it is transmitted by any kind of sexual contact.

There are no symptoms associated with this virus, although some types of HPV might result in genital warts. The only way of knowing if someone is infected is by having regular pap smears.

In the past year the UNLV Health Center performed 913 pap smears; out of those, 77 were positive for HPV, which accounts for 8 percent of all the women tested, said Tina Saddler, nurse practitioner and associate director of the Student Health Center.

Abstinence, safe sex, fewer sexual partners and a vaccine are a few ways to prevent HPV, said Annette Magnus, grassroots organizer of one the Planned Parenthood Clinic of Southern Nevada.

There are more than 30 types of the virus, but only four types may lead to cervical cancer in women. Types 6, 11, 16 and 18 are the main worry, but also the only ones that might be prevented by the vaccine Gardasil, Magnus said.

Currently, Gardasil is the only FDA-approved vaccine on the market that may help guard against those types of HPV. It is recommended for females between the ages of nine and 26, she said.

Magnus suggested that men should also take the vaccine as a way to prevent spreading the virus.

“The Gardasil vaccine is one of the most promising new medical advances of our time because it opens a whole new world of prevention and treatment,” said Carol Kobashigawa, clinician for Planned Parenthood of Southern Nevada.

It is believed that the HPV vaccine will reduce HPV exposure and therefore reduce the number of abnormal pap smear results and the follow up tests, Saddler said. It is also believed that it will decrease a woman’s chance of developing cervical cancer, which is most often caused by HPV.

The message is to catch the virus in its early stages so there is no chance of it becoming cervical cancer.

There are more than 20 million people in the U.S. who are infected and an estimated 6.2 million who will get the virus each year. Fortunately, in most people, the body’s defenses are enough to clear HPV, Saddler said.

Kathy Underwood, a nurse practitioner and associate director at the Health Center, said that women should know the center is there to help them and answer any questions they might have.

“It can be very scary, but we can help them sort it through and give them real information,” Underwood said.

Even though in the past few years HPV has been more advertised and talked about, there is still a lot to be learned. Women and men can talk to their health care provider and discuss the best ways to prevent or treat HPV.

Education will always be one of the best tools to prevent viruses like HPV and other STDs.

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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.

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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.

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Cervical cancer vaccine Gardasil gains acceptance in California

Los Angeles, CA

The cervical cancer vaccine Gardasil is gaining widespread acceptance in California despite its newness and some controversy over its safety, UCLA researchers have found.

One in four teenage girls in the state -- about 378,000 out of 1.5 million -- received at least one dose of the vaccine in 2007, its first full year of distribution, according to, released Tuesday by UCLA's Center for Health Policy Research.

Among those who had not started the series of shots, a majority of teens and young adult women expressed interest in receiving the vaccine, as did their parents, the survey found.

Gardasil provides protection against four strains of the human papilloma virus, which are associated with about 70% of all cervical cancers in the United States and 90% of genital warts. The vaccine is administered in three shots over a six-month period.

Uncertainty and safety concerns typically surround the introduction of any new vaccine, and Gardasil has been more controversial than most. In March 2007, the national Centers for Disease Control and Prevention recommended the newly licensed vaccine for 11- and 12-year-old girls and beyond, up to age 26. (The vaccine works best if given before a young woman is sexually active and may have already contracted the virus.)

The recommendation sparked a flurry of objections, both scientific and social.

Critics said that the vaccine, approved in June 2006, was too new for its long-term effectiveness and safety to be judged. Others said that it was too expensive and that it was unnecessary because an effective cervical cancer screening method, the Pap smear, exists already. And some parents said that giving it to young girls implies approval of premarital sex.

A large study published last year alleviated some safety concerns, finding only three confirmed allergic reactions in girls and young women who received the vaccine in Australia. And the CDC seal of approval prompted U.S. programs for the poor as well as many private insurance plans to cover the cost.

The study, the first to look at Gardasil vaccination rates within a single state, was based on a large database called the California Health Interview Survey, in which more than 50,000 Californians are periodically interviewed by phone.

The UCLA researchers said they would soon release additional data on how different ethnic and socioeconomic groups have complied with the recommendation.

Preliminary results showed few differences by race, ethnicity or economic status among adolescent girls, said sociologist David Grant, the survey director. The federal Vaccines for Children program provides free shots for those without insurance in this age group.

But in the older age group -- age 18 to 26 -- fewer Latinas and African American women got vaccinations.

This could be because coverage for the vaccine would not be automatic in this group, Grant said.

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Bill in Alabama could help prevent cervical cancer and save lives of women

Selma, AL

Cervical cancer claimed an estimated 3,870 women nationwide this year with another 11,070 reported cases, according to the National Cancer Institute.

Cervical cancer is a disease in which malignant cells form in the tissues of the cervix, located at the lower end of the uterus, leading to the vagina, or birth canal. Infection of the cervix with human papillomavirus (HPV) is the most common cause of cervical cancer, but it’s important to know that not all women with HPV infection will develop cervical cancer.

State Rep. James Gordon, D-Mobile, has pre-filed a measure in the Alabama House that would require the State Board of Health to provide each parent or guardian of a female student entering the sixth grade information about infection and the immunization against HPV. Further, the measure would require each school that enrolls a sixth grade female to have the parents or guardians furnish to the school by the 20th day of the new school year a written statement to reflect the parent or guardians had received the information; the student has received or is receiving the immunization or the parent/guardian has decided not to have the student’s information handed over to the school.

Knowledge can save lives. Gordon’s attempt at educating Alabama parents and guardians is on target.

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Few adverse reactions to cervical cancer vaccine

Washington, D.C.

Girls and young women given Merck and Co's (MRK.N: Quote, Profile, Research, Stock Buzz) Gardasil vaccine to prevent cervical cancer were not any more likely than usual to faint, have an allergic reaction, blood clot, or other adverse reaction, federal officials said on Wednesday.

The vaccine does not cause any more cases than usual of eight different adverse events, the U.S. Centers for Disease Control and Prevention found.

The report to the Advisory Committee of Immunization Practices was based on 375,000 doses of the vaccine given from August 2006 to July of 2008.

"As with all approved vaccines, CDC and FDA (U.S. Food and Drug Administration) will continue to closely monitor the safety of the HPV vaccine," the CDC said in a statement.

Gardasil protects against the four types of human wart virus, also known as human papilloma virus or HPV, that are most likely to cause cervical cancer -- a highly deadly type of cancer.

Because HPV is sexually transmitted and very common, most people are infected as young adults and to protect them, the vaccine must be given before girls are sexually active. This has led to some controversy.

The CDC said it received 10,326 reports of adverse events following HPV vaccination in the United States.

"Of these reports, 94 percent were reports of events considered to be non-serious, and 6 percent were reports of events considered to be serious," the CDC said. These included 27 deaths.

Such reports do not necessarily show that a vaccine has caused a disease or event -- they simply show that someone fainted, became ill or had an allergic reaction around the time they also received the vaccine.

"Reports of non-serious adverse events after HPV vaccine have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever," the CDC said.

"Fainting is common after injections and vaccinations, especially in adolescents."

Some of the serious events included Guillain-Barre Syndrome, a rare disorder that causes muscle weakness. It can be caused by a number of infections.

"There has been no indication that the HPV vaccine increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated," the CDC said.

Eleven of the deaths were traced to diseases such as diabetes or meningitis and unrelated to the vaccine, while the others were being investigated or did not provide enough information to assess, the CDC said.

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Nobel Prize to HPV researcher highlights importance of cervical cancer screening and prevention

Venlo, Netherlands [press release]

QIAGEN's HPV testing technologies are a successful commercialization of the Nobel Prize in Medicine winner's research

The Nobel Prize-winning discovery of the causal link between human papillomavirus (HPV) and cervical cancer has spurred lifesaving prevention technologies -- such as HPV testing and HPV vaccines -- that are helping to eradicate cervical cancer globally. The Nobel Prize Committee today announced that Professor Harald zur Hausen at the German Cancer Research Center in Heidelberg will receive this year's Nobel Prize in Medicine/Physiology for the discovery of certain human papillomaviruses (HPV) as the primary cause of cervical cancer. Expanding on Prof. zur Hausen's research, QIAGEN (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) developed and markets the digene(R: 49.52, +3.52, +7.65%) HPV Test, a screening test to detect the high-risk types of the HPV virus that cause cervical cancer. QIAGEN is also developing careHPV, a new HPV test specifically for use in regions of the world with scarce resources.

"Prof. zur Hausen has revolutionized cancer research and in particular cervical cancer research. His pioneering discoveries made the development of vaccines and novel diagnostics -- including our HPV testing platform -- possible, and today women around the world are benefiting from dramatically improved cervical cancer testing, treatment and prevention technologies. These innovations stem from the initial discoveries of Prof. zur Hausen. QIAGEN wholeheartedly congratulates Prof. zur Hausen on the Nobel Prize Award for his ground-breaking discovery. His vision and scientific excellence created a new paradigm for cancer research and led to such great strides in cervical cancer prevention," said QIAGEN CEO Peer Schatz.

The Nobel Prize winner's discovery that the human papillomavirus causes cervical cancer ushered in a new field of cancer-focused HPV genetics research. The identification of the causal role of the HPV virus in cervical cancer spurred research teams to identify the high-risk types of HPV most commonly linked to cervical cancer, then create molecular diagnostic tests to identify the presence of these high-risk types in cervical cells. Today, QIAGEN's digene HPV test is becoming a standard of care for cervical cancer prevention for use together with a Pap test in women age 30 and older, and the cervical cancer vaccine is helping protect populations of young girls from ever contracting two of the most prevalent strains of high-risk HPV.

"Prof. zur Hausen's seminal work spurred a new field of cancer research and, ultimately, a new generation of diagnostics and prevention technologies," said Dr. Attila Lorincz, Professor of Molecular Epidemiology at the Wolfson Institute of Preventive Medicine (UK) and Chairman of QIAGEN's Women's Health Scientific Advisory Board. "With the combination of Pap and HPV testing for women age 30+ and the availability of a vaccine to immunize young girls against certain strains of the virus before HPV exposure, the promise of the global eradication of cervical cancer is near. The development of these prevention technologies is the outgrowth of Prof. zur Hausen's discoveries. QIAGEN built on these discoveries and developed lifesaving testing technologies that today enable the identification of HPV -- the cause of cervical cancer -- before it can develop into disease, cause suffering and take lives." Dr. Lorincz led QIAGEN's development of the first ever diagnostic test for the high-risk types of HPV associated with cervical cancer.

Cervical cancer is the second-most-common cancer among women worldwide, and one of the most preventable ones. According to estimates 500,000 women are affected by cervical cancer every year causing around 250,000 deaths. The cancer is caused by sexually transmitted "high-risk" types of the human papillomavirus (HPV). Around 80 percent of women get an HPV infection at some point in their lives. However, in most cases, the infection goes away or is suppressed by the body without causing problems. It is only infections that persist that can cause abnormal cells to form that may develop into cervical cancer if not detected and treated early.

QIAGEN aims to make the benefits of HPV testing and early cervical cancer detection available to women across the globe. The digene HPV test and the careHPV test, currently in development, are screening tools that identify women most likely to have or develop cervical cancer by detecting the presence of the high-risk types of HPV which cause the disease. The digene HPV Test is the only FDA-approved and CE-marked test for the human papillomavirus, for use together with the Pap test in women 30 and older.

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Doctors: Gardasil cervical cancer vaccine is good for girls

Greensboro, NC

Questions remain about the long-term safety and effectiveness of a relatively new, widely used vaccine that could prevent most cervical cancers. But these questions aren’t stopping some local physicians from recommending the drug to patients as young as 9.

And they shouldn’t, says a Wake Forest University physician who led a committee that advises the U.S. Centers for Disease Control and Prevention on vaccinations.

The drug, Merck & Co.’s Gardasil, was approved by the U.S. Food and Drug Administration two years ago. It targets two strains of the human papilloma virus that are believed to cause about 70 percent of cervical cancers.

It also targets two other versions of the virus that cause genital and anal warts. These seldom advance to cancer but can be painful.

Cervical cancer is not common in the U.S. compared with other cancers. In 2004, the most recent year for which statistics are available from the CDC, 3,850 women died from the disease. That same year, almost 12,000 women learned they had it.

The main reason it is not more common is the widespread use of Pap smears, tests that can detect abnormal cells in the cervix well before they develop into cancer.

But worldwide, cervical cancer is the second-leading cause of cancer death in women, primarily because Pap smears aren’t as common in many countries.

Some 500,000 new cases are reported yearly, and 274,000 women die of the disease, almost all in developing countries.

Because Gardasil prevents only about 70 percent of cervical cancers, women still must get regular Pap smears.

But that doesn’t mean the vaccine isn’t valuable, says Dr. Wes Davis of Wendover OB-GYN and Infertility in Greensboro.

“The main thing to understand is it potentially prevents what can be a life-threatening disease,” Davis says “It’s promising to be very beneficial to the patient.”

Gardasil has been approved for use in girls and women between the ages of 9 and 26, but it is considered most effective in younger girls.

Dr. Kathleen Lucas, a Greensboro pediatrician, says she recommends Gardasil particularly for girls ages 12 to 13, because research has found that group developed the best antibody response to the virus after receiving the vaccine.

There are insufficient data to gauge the vaccine’s long-term effectiveness and safety, but Lucas says that was the case with many vaccines now in common use.

Dr. Jon Abramson led the CDC advisory committee that recommended the vaccine for all girls once they reach the age of 11 or 12.

Abramson, chairman of the department of pediatrics at Wake Forest’s medical school and physician-in-chief at Brenner Children’s Hospital, said the overall effectiveness of the vaccine could be affected by whether girls or women have been sexually active, because the vaccine does not protect people who already are infected.

The older a girl or woman, the more likely she has been sexually active.

Abramson says the likelihood of any long-term safety problems is low because the drug is a viruslike particle, not a live or dead virus as some vaccines are.

He conceded that patients might well need a booster of Gardasil in the future. But the committee did not want to wait 10 or 20 years to gauge long-term effectiveness when the drug could begin preventing cervical cancer in many women immediately.

The need for future boosters would make Gardasil no different from tetanus vaccine, for which patients must receive a booster about every 10 years, Lucas said.

Several questions also have arisen about the cost-effectiveness of Gardasil, in its own right — at $360 and up for a three-injection series, it is the country’s most expensive vaccine — and compared with other uses for health care dollars.

For one thing, although human papilloma virus is the most common sexually transmitted infection in the U.S., relatively few people who get it go on to get cervical cancer.

For another, some states might follow Virginia’s lead and make the vaccine mandatory for students. The New England Journal of Medicine recently devoted an article and an editorial to the cost-effectiveness of widespread vaccination.

Abramson said the drug is cost-effective under the benchmarks commonly used in assessing preventive measures. If people have to have booster shots in the future, that calculation could change.

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Michigan teen becomes center of debate over Gardasil cervical vaccine

Flint, MI

Sammie and Matia White thought they were following the law when they got their 17-year-old daughter vaccinated with Gardasil.

"The doctor told my wife it was mandatory. She said our daughter had to get the shot," Sammie White said. "We hadn't even considered it before then."

The Whites, who live in Flint, were featured on CNN earlier this month. In a short investigative report, Matia White and her daughter, Taquaria Williams, shared details of the illnesses Williams has suffered since getting her first dose of Gardasil.

The vaccine is said to help prevent cervical cancer by protecting against certain types of the human papillomavirus (HPV), which can cause the disease.

"She started having headaches, she was irritable," Sammie White said. "She just changed."

Willams received her first shot in December, and by February she had broken out with a rash all over her body and her hands and feet were swollen due to poor circulation, her father said.

Since the shot, she's also been diagnosed with connective tissue disorder, a form of lupus.

Sammie White recently said the family received news that Williams may lose her finger tips.

"She's never been sick before," Sammie White said. "Now she's taking six or seven pills a day."

The Food and Drug Administration licensed Gardasil in June 2006. Since then, the Center for Disease Control and Prevention has reported 6,667 incidents nationally of adverse events following the vaccine.

About 94 percent of the events were non-serious, including headaches and soreness at the injection site. The remaining six percent were more serious, including hospitalization, a life-threatening illness, permanent disability and death.

Seventeen young women died after getting the vaccine, but no connection between the deaths and the vaccine could be established, the CDC Web site reports.

Because Gardasil supposedly protects against HPV, a sexually transmitted disease, some conservative and religious groups oppose the vaccine because of concerns that it will promote sexual activity.

Bridget Maher, of the Family Research Council, a Christian Right non-profit think tank, told The New Scientist magazine, "Giving the HPV vaccine to young women could be potentially harmful because they may see it as a (license) to engage in premarital sex."

Ray Middleton of Flint said he's considered getting his 16-year-old daughter the Gardasil vaccine.

"We thought about it, but decided against it because our daughter isn't dating or sexually active," Middleton said. "At some point, I think we'll reconsider and at that time we'd have to consult with our doctor about the risk."

Barbara Lee Fisher, co-founder and president of the National Vaccine Information Center, said more research needs to be done on the vaccine.

"We're concerned about the number of high functioning girls that are collapsing within 24 hours of receiving the vaccine," Fisher said. "It's not just girls falling out because they're afraid of needles. It's something in this vaccine causing this collapse."

Dr. Thomas Wright, a gynecologist in the Flint area, said his private practice has vaccinated about 150 girls and young women with Gardsil.

Between 300 and 500 women and girls have received the vaccine at Women's Integrated Health, a division of Genesys Regional Medical Centers, where Wright also practices.

Despite the controversy surrounding the vaccine, Wright said he will still recommend Gardasil to his patients.

"None of this has been directly linked to the vaccine. That's what the data shows at this point," he said. "Until it's proved otherwise, I think it's safe. In fact, both of my daughters have been vaccinated with Gardasil."

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Drug makers’ push leads to cancer vaccines’ rise

New York, NY

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”
Dr. Diane Harper, a professor of medicine at Dartmouth Medical School
Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil’s list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).

Award-winning advertising has promoted the vaccines. Before the film “Sex and the City,” some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like “Law and Order,” a multiethnic cast of young professionals urges girls to become “one less statistic” by getting vaccinated.

The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients’ and women’s groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies’ involvement.

Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.

In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

“There was incredible pressure from industry and politics,” said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12.

“This big push is making people crazy — thinking they’re bad moms if they don’t get their kids vaccinated,” said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women’s Health Network. Canada will spend $300 million on a cervical cancer vaccine program.

Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she still be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary? Read more, "Drug makers’ push leads to cancer vaccines’ rise."

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HPV vaccine Gardasil's side effects prompt CDC study

Washington, D.C.

Merck is likely quite displeased with the barrage of negative press about its cervical cancer vaccine's side effects, especially after a public interest group, Judicial Watch, released a report at the end of last month saying there were 9,749 adverse reactions and 21 reported deaths related to Gardasil in the last two years.

According to the report, there have been 78 severe outbreaks of genital warts, six cases of Guillain-Barré syndrome and at least 10 miscarriages reported to the Vaccine Adverse Event Reporting System (VAERS) since the approval of Gardasil. However, a study in the New England Journal of Medicine found that clinicians, patients and drug companies report only about 10 percent of side effects to VAERS, so the actual number of Gardasil side effects could be much higher.

Some experts say Merck has also overstated the vaccine's effectiveness and that the evidence just isn't there yet. In light of the potential side effects and the drugs' young female target audience, many also are questioning Merck's continual push to place the drug on state mandatory vaccine lists.

For its part, Merck says there is no evidence that the vaccine and the reported side effects and deaths are related, and the CDC plans to release a study in October that will help determine whether a true linkage between Gardasil and the reported adverse reactions exists.

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Cervical cancer preventin: Gardasil HPV vaccine doubts grow

Los Angeles, CA

The safety and effectiveness of the HPV vaccine Gardasil as a preventive cervical cancer treatment for girls are questioned in a report.

Sandra Levy wants to do everything she can to safeguard the health of her 11-year-old daughter -- and that, of course, includes cancer prevention. She has had her child inoculated with one shot of Gardasil, the human papilloma virus vaccine that may prevent cervical cancer. But now, she says, she has serious reservations about going ahead with the next two injections of the course.

"It's very confusing, and we really don't know if it's 100% safe," says Levy, of Long Beach. "I'm not against vaccines, but I don't want to do anything that would harm my daughter."

Though most medical organizations strongly advocate using the HPV vaccine, some doctors and parents, like Levy, are asking whether the vaccine's benefits really outweigh its costs. They say they aren't convinced that the expensive shots offer any more protection than preventive measures already available -- principally, regular screening via the Pap smear test.

A handful worry that blanket immunizations of the nation's adolescents could backfire by lulling them into a false sense of security that leads them to neglect regular screening. If that happened, vaccination could eventually boost cervical cancer rates instead of lowering them.

In addition, because Gardasil protects only against the HPV strains linked most strongly to cervical cancer, "we don't know if it will make a difference in the ultimate rates of cancer," says Abby Lippman, an epidemiologist at McGill University in Montreal who has researched the HPV vaccine. "The jury is still out on how much benefit we're actually going to get with this vaccine."

A report released in June stirred up more doubts. Although cause and effect were not proved, the report listed serious events -- such as seizures, spontaneous abortions and even deaths -- among teens, preteens and young women who had earlier had Gardasil shots.

As a result, the decision -- to vaccinate or not? -- has become controversial. Sorting through the pros and cons can be daunting for many parents.

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California legislature passes HPV vaccine coverage bill

Sacramento, CA

The Legislature passed a bill Thursday to require insurers to cover vaccinating young women against the virus that causes cervical cancer.
The vote was 49-26, according to the announcement. The bill now heads to the governor's desk.

"This vaccine saves lives," said Assemblywoman Noreen Evans,

D-Santa Rosa, who represents Vallejo and was the bill's co-author. "California has more cases of cervical cancer than any state in the country. We routinely vaccinate our youth for other diseases. It's foolish not to add this vaccine to that list."

Assembly Bill 16 also requires health plans and insurers that include coverage for the treatment of cervical cancer to provide coverage for an annual cervical cancer screening test. The bill would expand existing preventative care coverage requirements to include vaccination for the human papillomavirus which causes most cervical cancer cases.

Approved by the Food and Drug Administration in 2006, the vaccine is 98 percent effective when administered to patients with no prior HPV exposure, Evans' office notes.

Current law fails to protect millions of women within the full age range - 11 to 26 - recommended by the FDA for receiving the vaccine, Evans' office added. The vaccine is administered in three doses over six months and costs about $360.

The American Cancer Society estimates that more than 11,000 new cases of invasive cervical cancer will be diagnosed in the United States this year. In California, almost 1,400 women will be diagnosed with the disease and nearly 400 will die from it.
AB 16 passed the Senate 25-13 last month. AB 16 mirrors Evans legislation that was vetoed by the governor last year.

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Merck's Gardasil not cleared by FDA for older women

New York, NY

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday.

Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are "issues" that preclude approval within the expected review time frame, Merck said.

"It's hard to get a feel for if this is a dead issue or if this is delayed," said Linda Bannister, an analyst for Edward Jones. "At the minimum, it's going to be delayed."

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. The company for now is dropping plans to pursue that expansion, a spokeswoman said.

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Mandatory HPV / cervical cancer vaccine moves forward in Iowa

Only two steps remain in Iowa's legislative quest to require insurance companies to provide coverage of vaccinations for the human papillomavirus, the major cause of cervical cancer.

The proposed bill was passed by an 81-16 vote of the Iowa House last week and referred to the Senate Human Resources Committee. All 16 House members opposing the measure were Republicans, six of them women.

Tuesday morning, the Senate committee, chaired by Assistant Majority Leader Joe Bolkcom, D-Iowa City, approved the measure and sent it on to the full Senate floor. The bill will need to pass through the Senate -- something that is considered likely -- and will need to be signed by Gov. Chet Culver. The law would take affect for third-party payment provider contracts, policies or plans delivered, continued or renewed in the state after Jan. 1, 2009.

"Cervical cancer is preventable," Bolkcom said. "The HPV vaccine is the best defense. This bill will ensure that health insurers make the HPV vaccine available and affordable to Iowa women. I expect the Senate to approve this bill soon." More >>

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Cervical cancer vaccine put on fast track for review by FDA

Elkhorn, CO

Merck & Co on Wednesday said U.S. regulators have granted a priority review for the company's application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45.

The designation means that the U.S. Food and Drug Administration is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.

Gardasil, one of Merck's fastest-growing products, is currently approved for girls and women nine through 26 years of age. It works by preventing infection with four sexually transmitted strains of the Human Papillomavirus that cause most cases of cervical cancer. More >>

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GSK Cervical Cancer HPV Vaccine Cervarix Reported Effective for More Than Six Years

Falls Church, VA

GlaxoSmithKline (GSK) has new data that it says shows that its experimental cervical vaccine Cervarix protects women against the four most common types of the human papillomavirus known to cause cervical cancer for nearly six and a half years.

Over this period, which is the longest for protection reported to date, Cervarix “showed 100 percent efficacy in preventing precancerous lesions due to cancer-causing virus Types 16 and 18 and also provided substantial protection against infection caused by virus Types 31 and 45,” the company said.

The data came from an extended follow-up analysis of 776 women ages 15–25 in the U.S., Canada and Brazil who had participated in an initial efficacy study of the vaccine. Nearly 100 percent of the women in the study maintained high levels of antibodies against virus Types 16 and 18 at all times for close to six and half years, GSK said.

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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.

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Gardasil vaccine now offered for boys, young men

Normal, IL

Approximately 3,700 women die from cervical cancer every year, making it the second leading cause of cancer deaths among women around the world.

To prevent the risk of cervical cancer, which is caused by the Human Papillomavirus, millions of girls and young women in the United States get vaccinated with Gardasil before becoming sexually active. Gardasil is recommended for girls before sexual intercourse.

By 2009, Gardasil could be approved for use by boys and young men as well.

"A lot of folks would say, 'Let's not force everybody to take [vaccinations] because not everybody is sexually active, and we don't want to send the message that everybody is,'" ISU health educator James Almeda said. "I think what I would explain to folks is, 'Maybe your son or daughter isn't [sexually active], but there could be some point in time where they choose to be, and we're not going to always be able to protect them.'"

"Because we know that HPV is so prevalent, we know there is a good chance that they could be exposed to it at some point in their life, and so why not use [vaccinations] as a safety precaution," Almeda said. More >>

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Gardasil HPV vaccine can reduce risk of cervical cancer

Centers for Disease Control and Prevention

Preventative measures can reduce risk factors for certain types of cancer (including cervical cancer), even those caused by infections. Human papillomavirus, or HPV, is a group of viruses consisting of more than 100 different strains. It is also the virus that causes genital HPV infection, a sexually transmitted disease that can lead to cervical cancer in women.

Dr. John Browning of McLeod OB/GYN Associates said that Gardasil is an effective way to protect young people from a heightened risk of developing cervical cancer later in life. Doctors such as Browning tell their patients about the importance of the vaccine and annual Pap smears in the prevention and detection of cervical cancer. “The vaccine can prevent what we think is 75 percent of (cervical) cancers, but it won’t change our recommended (Pap smear) screening,” Browning said

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Texas controversy stirs interest in HPV vaccine

Galveston, TX

Some pediatricians say last year's controversy over whether the state should mandate Texas schoolgirls to be vaccinated against the human papillomavirus has translated into more individuals getting the vaccine.

"It's really kind of an interesting thing — the controversy has really helped us get the word out," said Chris Turley, vice chair for clinical services at the University of Texas Medical Branch's Pediatrics Department.

"We really do have moms coming and asking for it. ... People forget about the tetanus shot because it's been around forever, but they come in knowing about this and wanting it for their daughters." More >>

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National Cervical Cancer Coalition Stresses Importance of Screening and Prevention During January Cervical Health Awareness Month

December 27, 2007 (Van Nuys, CA)

Women Urged to Take Action and Protect Themselves in New Year

Approximately 10,000 American women will learn they have cervical cancer/HPV this year, and nearly 4,000 will die from an advanced form of the disease. This January, during Cervical Health Awareness Month, the National Cervical Cancer Coalition (NCCC) is focused on educating women about the importance of the Pap test as a screening tool for cervical cancer/HPV and about vaccines that can further reduce the burden of this devastating disease.

It's the start of a new year - a time many reflect on their health. To start the year right, we encourage women to contact their health care provider to schedule a Pap test to check for cervical cancer. This screening is a crucial part of a woman's health care regimen, yet one that many overlook. "It's important to remember that cervical cancer is a preventable disease - as long as it's caught early enough," says Ms. Sarina Araujo, Executive Director of the NCCC.

While routine administration of Pap tests is the best means of detecting cervical cancer at an early stage, vaccines have the potential to protect women from the disease, by targeting cancer-causing types of the human papillomavirus (HPV). HPV, a virus transmitted through sexual contact, is the single known cause of cervical cancer. Two forms of the virus, HPV 16 and HPV 18, account for more than 70 percent of all cervical cancer cases. Some medical experts believe that through a successful education, screening and vaccination program for women, we will have the potential to nearly eliminate cervical cancer in the U.S.. More >>

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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 >>

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Ask Dr. Weil: Is the HPV cervical cancer vaccine safe?

December 11, 2007

This Q&A was published in the Rock Mountain News: "HPV vaccine a sure lifesaver for thousands."

I have a teenage daughter, and I'm wondering about getting her the vaccine that prevents cervical cancer. Is it really safe?

The vaccine you're wondering about protects against infection with two strains of the human papillomavirus (HPV), which are responsible for 70 percent of all cases of cervical cancer.

The FDA approved the vaccine (Gardasil) in June 2006, and that same month, a federal advisory panel on immunization practices recommended that all 11- and 12-year-old girls be vaccinated. More than half of all men and women pick up HPV within a year of becoming sexually active. The vaccine won't work for women who are already infected with HPV, which is why it's important to immunize young girls before they become sexually active.

In 90 percent of all cases, HPV infections clear up on their own and cause no obvious symptoms (except, in some cases, genital warts; the new vaccine will also protect women against the viruses responsible for 90 percent of all cases of warts).

About 10,000 women in the United States develop cervical cancer every year, and the disease leads to about 3,900 deaths annually. Most of those cases and deaths could be prevented if all women had Pap smears. Worldwide, cervical cancer kills more than 288,000 women a year.

The vaccine undoubtedly will save thousands of lives around the world among your daughter's generation and future generations of women.

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