Presentation to FDA intended to raise awarenes of Gardasil cervical cancer vaccine risks

Critics of Gardasil vaccine speak up to FDA about Gardasil risks

FORT WAYNE, Ind.

A Fort Wayne couple is keeping their fingers crossed that a presentation Friday before Food and Drug Administration officials will open eyes about the risks associated with the Gardasil vaccine.
Multimedia.

Several FDA offices were scheduled to hear testimony on behalf of parents who say their daughters have died or suffered debilitating side effects from the drug designed to prevent cervical cancer.

Dan and Kim Chitwood's daughter Taylor has battled seizures since taking Gardasil shots two and a half years ago.

Kim Chitwood says, “Just very hopeful that this will be presented in a way that, um, nationally and worldwide, people will find out about Gardasil and things that it can cause."

Caleigh Miller of Fort Wayne is also suffering from seizures; a problem her parents are convinced is a result of Gardasil shots.

The Centers for Disease Control stand behind the vaccine, as a safe way to prevent cases of cervical cancer that health officials insist will otherwise kill thousands of women.

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Pap smear test: Regular cervical cancer screening should not be missed, says Illinois Public Health Director

Decatur, IL

Sexual health is a notoriously difficult subject to bring up, but time after time, research has shown that awareness saves lives.
In recognition of Cervical Cancer Awareness Month, Illinois Public Health Director Dr. Damon T. Arnold's office issued a press release urging Illinois women to proceed as recommended with their regular screenings.
Dr. Derin Rominger, a Decatur Memorial Hospital obstetrician-gynecologist, said the guidelines for cervical cancer screenings have changed in recent years.
The former guidelines stated that women should begin receiving Pap smears, tests for changes in the cells of the cervix, at age 18 or upon becoming sexually active, Rominger said.
"We just don't see that much cervical cancer in the teenage group," he said. "They seem to be able to clear the virus that causes these problems."
New guidelines state that women should start getting the tests at age 21 or three years after becoming sexually active, Rominger said.
Once women start receiving the screenings, those who fall into the lower-risk categories of being in a monogamous relationship and having a series of negative Pap smears will need them less often, Rominger said. But those who have had abnormal smears in the past, have had new sexual partners or are immunosuppressed will need to be screened annually, he said.
Research has shown a strong connection between certain strains of human papillomavirus, or HPV, and cervical cancer, Rominger said. Two main strains are responsible for 90 percent of cervical cancers, he added.
"Basically, we've known for a long time there was some sort of a factor," Rominger said of the relationship between HPV and cervical cancer.
In the past few years, vaccines such as Merck's Gardasil and GlaxoSmithKline's Cervarix, which protect against some of the strains known to cause cervical cancer, have become available.
Vaccination is one thing young women can do to reduce their risk of HPV infection and, ultimately, cervical cancer, Rominger said. Women between the ages of 11 and 26 currently are eligible for vaccination.
Although doctors prefer to give the vaccine to women before their "sexual debut," Rominger said, "just because she's been sexually active or had an abnormal Pap smear doesn't mean she's not eligible for the vaccine."
Another measure of protection is to practice safer sex, he said. Use a condom to protect against transmission of the virus and other sexually transmitted diseases.
Refrain from smoking, which has been shown to double the risk of cervical cancer, Rominger said. And be sure to get in for routine Pap smears as they are recommended by a physician, he added.
"The whole key is that early detection," Rominger said.
In 16 years of practice, he has seen only seven cases of cervical cancer. All of those women had gone at least 10 years or more without a Pap smear, he said.
The screenings save lives by locating precancerous cells, and doctors sometimes must take measures to remove those growths, Rominger said.
"Those are the ones that have a greater chance of progressing to cervical cancer," he said.
According to the recent release from Arnold's office, it is estimated that in 2010, 610 women in Illinois will be diagnosed with cervical cancer, and about 180 will die from it.
But those deaths are avoidable through routine screenings and preventive measures, Arnold said.

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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 Gardasil approved by FDA for men to prevent genital warts (HPV)

Washington, D.C.

The U.S. Food and Drug Administration approved the vaccine given to women to prevent cervical cancer for use in men and boys to prevent genital warts.

The drug, Gardasil, is already approved for women ages 9 through 26 to prevent cervical, vuvlar and vaginal cancer caused by the human papillomavirus and genital warts. The agency on Oct. 16 approved it for men in the same age group.

HPV is the most common sexually transmitted disease in the United States and most genital warts are caused by the virus, the FDA said in a statement. About 2 out of every 1,000 men in the United States are newly diagnosed with genital warts every year, according to the FDA.

The agency said that Gardasil was almost 90 percent effective in preventing warts caused by HPV.

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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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Cervical cancer vaccination rate for teeneage girls is 1 in 3, says CDC

Atlanta, GA

ne in three teenage girls have rolled up their sleeves for a vaccine against cervical cancer, but vaccination rates vary dramatically between states, according to a federal report released Thursday.

The highest rates were in Rhode Island, New Hampshire and Massachusetts, where more than half of girls ages 13 through 17 got at least one dose of the three-shot vaccination. The lowest rates were in Mississippi, Georgia and South Carolina, where fewer than 20 percent got at least one shot.

The report is the first to give state-by-state rates for Merck's Gardasil vaccine. It targets strains of the sexually transmitted human papillomavirus that cause about 70 percent of cervical cancers. It came on the market in 2006.

Health officials recommend that girls get the shots when they are 11 or 12, if possible, before they become sexually active so they have immunity before they are first infected. The shots are approved for females 9 through 26.

The Centers for Disease Control and Prevention study involved a 2008 telephone survey of the parents of nearly 18,000 adolescents, who allowed researchers to check their kids' vaccination records.

Nationally, there was an increase in the percentage of teens ages 13 to 17 vaccinated against meningitis, tetanus, diphtheria and other illnesses. The agency also noted a rise since 2007 in the percentage of teenage girls who had gotten at least the first dose in the three-shot vaccination series against cervical cancer.

In 2007, about 25 percent had gotten a first dose of the vaccine. Last year, it rose to about 37 percent.

CDC study also found that the number of girls who got the whole three-dose series was only 18 percent and the rate was higher for white girls than for blacks or Hispanics.

Vaccine proponents had been hoping for higher vaccination rates, saying the shots could dramatically reduce the nearly 4,000 cervical cancer deaths that occur each year in the United States.

It's not clear why state vaccination rates vary so much, but several factors could be involved, said Dr. Melinda Wharton, an administrator of the CDC center that did the research.

Money is an issue. Retailing at $390 for the three-dose series, Gardasil is the most expensive childhood vaccine.

Many health insurers pay for the shots, but health officials noted variations in public insurance coverage. A federal program pays for certain children, including those who are uninsured or are in state Medicaid programs, but some states were slower to take advantage of it than others.

Also, it takes three trips to the doctor over six months to get all the shots, and some parents are unable or unwilling to take their kids to the doctor that often.

In South Carolina, many parents have said they are concerned about the safety of the vaccine or that they don't understand why a girl should get vaccinated before she's sexually active, said Heather Brandt, a University of South Carolina public health researcher.

"It's disturbing to see those states at the lower end of participation," she added. "Because those are states with some of the highest rates of cervical cancer."

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FDA approval for Cervarix and Gardasil recommended by committees

Washington, D.C.

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

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

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

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FDA panel backs Glaxo's Cervarix cervical cancer vaccine

Gaithersburg, MD

GlaxoSmithKline PLC's proposed cervical cancer vaccine is safe and effective for girls and young women ages 10 to 25, a U.S. advisory panel said on Wednesday.

The endorsement from Food and Drug Administration advisers moves the Cervarix vaccine closer to the U.S. market to compete with Merck & Co's Gardasil shot.

The panel will vote later Wednesday on whether Merck should be allowed to widen its potential market by promoting Gardasil for men and boys as young as 9 for prevention of genital warts.

Both vaccines are designed to protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.

"The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health, adding "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological harm.

The committee voted 12-1 that Cervarix was effective.

The FDA usually follows panel recommendations. Glaxo said a final decision on Cervarix may come as early as this month.

The vaccine already is approved in 98 countries, but some analysts say it will be hard for Glaxo to compete against Gardasil's three-year headstart in the U.S. market. Gardasil won FDA clearance in 2006, while Cervarix stalled following Glaxo's initial application in 2007.

The delays mean Cervarix is no longer the mega blockbuster hope it once was, although FDA approval could still be a minor positive catalyst for Glaxo shares, Citigroup analysts said.

Four years ago, previous chief executive Jean-Pierre Garnier touted the vaccine as Glaxo's most important new product. But the British drugmaker missed the opportunity to vaccinate the initial group of eligible teenage girls in the United States, ceding that business to Gardasil.

Consensus forecasts ahead of the panel decision suggest Cervarix will generate worldwide sales of about $1.2 billion in 2013, equivalent to some 2.5 percent of expected Glaxo sales for that year, according to Thomson Reuters I/B/E/S.

Cervical cancer is often caught early in the United States through Pap smears while the disease is treatable. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.

"If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year," said Barbara Howe, director of Glaxo's North American vaccine development.

The company promised to track potential complications and miscarriages after approval. Neither Cervarix nor Gardasil is recommended for pregnant women.

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Study on adverse effects Gardasil reveals two adverse effects are more common than was expected

Philadelphia, PA

Three years after the world's first cervical-cancer vaccine was hailed as a public-health breakthrough, Gardasil is facing renewed questions about its safety and value.

In today's Journal of the American Medical Association, federal researchers analyze 12,424 voluntary reports of post-vaccination "adverse events" ranging from headaches to deaths. They conclude that only two complaints - fainting and dangerous blood clots -- are more common than expected and may be related to the immunization.

But an accompanying editorial points out that many questions about Gardasil remain - key among them, whether it really will reduce the toll of cervical cancer.

Another opinion piece in JAMA looks at Merck & Co.'s marketing strategy, contending the company coopted professional medical societies to promote and recommend the vaccine.

Merck - already on the defensive over Gardasil's second-quarter sales, which slumped sharply in the United States and worldwide - said in a statement that "we welcome continued study and discussion" of the product's safety.

"The bottom line is that Gardasil has a very positive benefit-risk profile," Richard M. Haupt, head of Merck's clinical program for the vaccine, said in an interview.

Gardasil, a series of three shots, protects against two strains of the sexually transmitted human papillomavirus (HPV) that cause 70 percent of cervical-cancer cases. Gardasil also wards off two other HPV strains that cause 90 percent of genital warts in men and women.

Next month, advisers to the Food and Drug Administration will consider whether to recommend expanding Gardasil's current approval for females ages 9 to 26 to include males of the same age. Vaccinating men would reduce HPV transmission to women and protect men from very rare HPV-related anal, head, and neck cancers.

The FDA panel will also review data on would-be rival Cervarix, the cervical-cancer vaccine for which GlaxoSmithKline is seeking FDA approval. Cervarix does not protect against genital warts.

Although the theory behind these vaccines is sound - if you prevent HPV infection, you prevent cervical cancer - the reality is more complex, infectious-disease expert Charlotte Haug wrote in the JAMA editorial.

No one knows whether Gardasil will require booster shots, or whether suppressing the two main cancer-causing HPV strains will drive rarer, equally dangerous strains to fill the void. That is why vaccinated women still need to get Pap smears, the routine screening test that can catch precancerous changes years before they turn malignant.

Most of the world's 250,000 cervical-cancer deaths each year occur in poor countries. Screening has made the disease relatively rare in the United States, where there are 10,000 new diagnoses and 3,700 deaths each year.

In Haug's view, the overall benefit of vaccination is so uncertain that a regularly screened woman "should be willing to accept only a small risk of harmful effects." More >>

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The cervical cancer vaccine question: Gardasil for my daughter?

St. Petersburg, FL

When Raffi Darrow brought in her two daughters, Wendy and Alice, for their annual back-to-school checkups this week, for the first time in her career as a mom, Darrow decided to be a rebel.
Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Raffi Darrow decided not to get the HPV vaccine for daughters Wendy, left, 11, and Alice, 12.

Even though every federal health authority says her girls, ages 11 and 12, should get Gardasil, the vaccine that helps protect against cervical cancer and genital warts caused by the human papillomavirus, Darrow instructed the pediatrician not to give it to them.

"Up until now my children have had every vaccine doctors have recommended," says Darrow, a graphic designer in St. Petersburg, Florida. "But most friends, like me, fear the safety of something new."

Even though Gardasil is on the Centers for Disease Control and Prevention's vaccine schedule for 11- and 12-year-old girls, and is recommended by the American Academy of Pediatrics, many parents interviewed by CNN say they're not getting it right now for their daughters out of concern for side effects.

"I'm not saying I'll never do it. I just don't want to do it when they're 11 or 12," says Darrow, who debated for a year about whether to get the shots for her daughters.

Liz Schlegel, on the other hand, didn't hesitate to get Gardasil for her 15-year-old daughter. "My older sister was diagnosed with (and beat!) cervical cancer two years ago, and her doctors traced it to HPV," says the manager of a small design firm from Waterbury, Vermont. "I would hate to think that normal sexual experimentation -- the kind that my sister and I and many of our friends and peers "tried on" in college -- could result in a life-threatening illness 30 years later."

A survey of 1,122 physicians in Texas showed that about half don't always recommend Gardasil to parents of 11- and 12-year-old girls, even though the CDC recommends it. The survey was published earlier this month in Cancer Epidemiology Biomarkers & Prevention, a journal of the American Association for Cancer Research.

In an unscientific QuickVote poll, respondents were split on whether they'd get the vaccine for their daughters, with 43 percent saying absolutely they would, 40 percent saying no way, and the rest saying they weren't sure. As of Wednesday, more than 5,000 people participated in the informal survey. To cast your vote go to CNNhealth.com.

Unlike most other vaccinations, Gardasil is not required for a child to attend school. As of 2007, the latest year for which statistics are available, 25 percent of 13- to 17-year-olds had received a dose of Gardasil, according to the CDC. Read what parents and pediatricians have to say about Gardasil »
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"Although the numbers are low, we are optimistic this percentage will increase over time," says Arleen Porcell-Pharr, a spokeswoman for the federal agency. "We would like to see 100 percent adherence to the CDC schedule, [but] from previous experience, we know that it takes years for a new vaccine to gain acceptance into the market."

Darrow and other parents say they're worried about neurological problems, blood clots and deaths that have been reported to the CDC after a woman or girl has been vaccinated with Gardasil. The vaccine is given in a series of three injections. Read a discussion on TwitterMoms about Gardasil

According to the Vaccine Adverse Event Reporting System run by the CDC and the Food and Drug Administration, as of May 1, there were 13,758 reports of adverse events occurring after women and girls received Gardasil, out of the more than 24 million doses that had been given to girls and women up until that time. On its Web site, the CDC notes that these events "may or may not have been caused by the vaccine."

Most of the problems -- 93 percent -- were considered to be mild, such as headache, nausea and fever. But 7 percent involved a hospitalization, permanent disability, life-threatening illness or death.

In the data, 39 deaths were reported after vaccination with Gardasil, with 26 confirmed by the agency, six under investigation, and seven unconfirmed. "There was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine," according to the CDC's Web site.

Gardasil, which prevents four types of human papillomavirus that cause 70 percent of all cervical cancers and more than 90 percent of genital warts, was heralded as a breakthrough when it was introduced more than three years ago by the pharmaceutical company Merck.

Since the reports, Merck has added several adverse reactions to the labeling, stating that some people after receiving Gardasil have developed autoimmune diseases, musculoskeletal disorders, paralysis and seizures.

"It's not possible to reliably estimate the frequency [of these adverse events] or to establish a causal relationship to vaccine exposure," the label states.

Dr. Rick Haupt, the pediatrician who leads Merck's research on Gardasil, says the vaccine is safe and effective for 11- and 12-year-old girls. "We have good evidence that the vaccine is appropriate to use at this age," he says.

He added that many countries, including the United States, recommend the shot at age 11 or 12 in hopes of getting girls vaccinated before they become sexually active, because HPV is transmitted sexually. Also, he says it's beneficial to vaccinate children this age because their "immune response is very robust."

Doctors and Gardasil

When her children were younger, Darrow's pediatrician urged her to get all the vaccines on the CDC schedule. She noticed, however, that when she told the pediatrician she didn't want Gardasil for Wendy and Alice, the doctor didn't push her to reconsider.

"There was no argument, no trying to persuade me, no 'Here's a pamphlet about Gardasil,' nothing," Darrow says.

Several pediatricians interviewed by CNN said they don't push the HPV vaccine if parents don't want it.

"I consider this to be an optional vaccine," says Dr. Arthur Lavin, associate clinical professor of pediatrics at Case Western Reserve University School of Medicine. "I tell parents it's fine with me if you wait, and it's also fine with me if you want that extra added level of protection and we proceed today."

He said about 15 percent of his patients are getting Gardasil for their 11- and 12-year-old girls.
Health Library

* MayoClinic.com: HPV infection
* MayoClinic.com: Cervical cancer
* MayoClinic.com: Cervical cancer vaccine: Who needs it, how it works

Parents researching on the Internet

Before her daughters' checkups this week, Darrow spent several hours doing research on the Internet in order to make her decision about Gardasil.

She said what tipped the scales for her were statements made in the media by Dr. Diane Harper, an obstetrician and gynecologist at the University of Missouri who helped Merck do clinical trials on Gardasil, at one point serving on the company's advisory board for the vaccine.

Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

"Gardasil is not without risks. It's not a freebie," Harper says.

Harper says she worries that not enough young girls were included in Merck's clinical trials to warrant giving the shot to all young girls.

Merck has given the vaccine to 1,121 girls between 9 and 15 years old in clinical trials without serious side effects, according to Haupt, the Merck pediatrician. He says the company will try to continue to follow these girls for 10 years.

In addition to safety concerns, Harper said she wonders whether the vaccine will still be effective for an 11- or 12-year-old after she's become sexually active.

Gardasil is "100 percent" effective against HPV five years after vaccination, according to Haupt, and Merck is studying whether its efficacy lasts longer than that.

Darrow says this is one reason she decided not to get the shots for Wendy and Alice. "Even if the shot lasts for 10 years, it would run out just when they're at their riskiest time," she says. "If I give it to my 11 year old right now, she'd need a booster at age 21."
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She added that she hasn't rejected the idea of getting Gardasil for her daughters, considering that it would give them some protection against cervical cancer.

"I'm going to revisit this again when they're 14 or 15," she said.

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World Health Organization approves Cervarix cervical cancer vaccine

London, UK

The World Health Organization approved a second cervical cancer vaccine, this one made by GlaxoSmithKline PLC, meaning U.N. agencies and partners can now officially buy millions of doses of the vaccine for poor countries world-wide.

Glaxo said in a statement Thursday the approval would help speed access to Cervarix. WHO had previously approved Gardasil, a competing cervical cancer vaccine made by Merck & Co. With two cervical cancer vaccines now ready to be bought by donor agencies, officials estimate that tens of thousands of lives might be saved.

More than 80% of the estimated 280,000 cervical cancer deaths a year occur in developing countries. In the West, early diagnosis and treatment has slashed the disease's incidence.

Last year, the global health association GAVI, formerly known as the Global Alliance for Vaccines and Immunization, prioritized the purchase of cervical-cancer vaccines for the world's 73 poorest countries. GAVI includes U.N. agencies, the World Bank and the Bill & Melinda Gates foundation and is a major buyer of vaccines for the developing world.

"We're very eager to offer women in developing countries these vaccines because without early screening, they are arguably more vulnerable to cervical cancer," said Dan Thomas, a GAVI spokesman. Mr. Thomas said the vaccine's price was essential to making it available to poor countries.

In the West, the vaccines typically cost about $360 for a three-shot dose -- which is far too expensive for poor countries, Mr. Thomas said.

Mr. Thomas said GAVI is in talks with drug makers, but that it still isn't clear whether either Merck or Glaxo might sell their vaccines to donor agencies at a cheaper price.

Cervarix hasn't been approved for use in the U.S. or Japan, but is available in 97 other countries. In the U.S., the cervical cancer vaccine market has been cornered by Gardasil since its approval in 2006.

The FDA is expected to decide within the next few months whether to approve Cervarix. Gardasil racked up $426 million in global sales in the most recent quarter, versus $69 million for Cervarix, which has won more contracts from government health programs beyond the U.S.

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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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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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CDC takes closer look at Gardasil and Paralysis

Washington, D.C.

Phil Tetlock and Barbara Mellers were in a race against time to save their 15-year-old daughter, Jenny. As I reported last summer, Jenny developed a degenerative muscle disease nearly two years ago, soon after being vaccinated against the cervical-cancer-causing HPV. She became nearly completely paralyzed, though her mind was perfectly intact and she could still enjoy her pet parakeet, Hannah Montana, and Twilight.

I've been E-mailing Phil regularly over the past year, and up until our last E-mail, one week ago, he had been holding out hope that they would be able to find a cure for his daughter—or to at least determine if the human papillomavirus vaccine called Gardasil had caused his daughter's illness, most likely a juvenile form of amyotrophic lateral sclerosis (aka Lou Gehrig's disease). Sadly, the clock ran out last Sunday, and Jenny passed away.

Through their efforts to publicize Jenny's case on their blog, Jenny's parents have connected with two other sets of parents whose daughters developed what appears to be ALS after being injected with Gardasil. One was 22-year-old Whitney Baird, who died last August, just 13 months after receiving Gardasil. Another is Alicia Olund, a 12-year-old who began having trouble walking after getting her third shot last September. She now uses leg braces and a walker at home as her muscles continue to deteriorate. After ruling out other conditions, her specialists at the University of California-San Francisco Medical Center—who also treated Jenny—suspect that Alicia may have the same condition. "They don't know what she has," her mother, Barbara, tells me through tears, "but it's destroying her nerves and muscles, and none of the treatments they've given her are working. Before the vaccine, she was a perfectly healthy child, going for her brown belt in karate." (They're awaiting the results of the ALS test.)

I should point out that juvenile ALS is extremely rare, affecting just 1 in 2 million young people. It's impossible to say at this point whether these girls would have developed the condition regardless of whether they received Gardasil, but government officials—who still strongly maintain that the vaccine is perfectly safe and potentially lifesaving—are now starting to investigate. Scientists from the Food and Drug Administration met recently with Jenny's neurologists at UCSF to discuss whether it's scientifically plausible for a vaccine to trigger ALS. And the Centers for Disease Control and Prevention is planning to scour its adverse-event database, called VAERS, to see whether other vaccinations have led to reports of ALS or other severe neurological complications.

Turns out, warnings concerning ALS and vaccines have been raised before. John Iskander, the CDC's associate director for immunization safety, tells me the agency previously has received reports of ALS following the anthrax vaccine. This, in addition to the deaths of Jenny and Whitney, "kind of tells us that we need to look more broadly at this issue," he says. He's quick to add that "we're doing just an initial review at this point; we don't have suspicions that these are casually related."

Merck, the manufacturer of Gardasil, maintains that its vaccine is extremely safe and points out that it could potentially save women from dying of cervical cancer. "There are unusual and rare diseases that occur in girls and women in this age group whether they're vaccinated or not," says Rick Haupt, Merck's head of the clinical program for Gardasil. "These patterns don't indicate any causality." He says no cases of ALS occurred in Merck's clinical trials but also admits that the trials—which included thousands, not millions—weren't large enough to detect such rare diseases.

Barbara Shapiro, an ALS expert and associate professor of neurology at Case Western Reserve University School of Medicine who was enlisted by a mutual friend to help the Tetlocks do their research, isn't ready to dismiss the cases as pure coincidence. She's pored over the medical records of Jenny, Whitney, and Alicia and sees a striking similarity. "Juvenile ALS tends to progress very slowly over years or even decades, but these girls all seemed to have a more rapid, progressive form." She also has uncovered another VAERS report in the CDC database that could be similar, but since it was filed by a pharmacist, the CDC told her it doesn't have details on the girl's identity. Shapiro worries that there may be more cases out there that the CDC doesn't know about.

After all, she tells me, both Whitney and Alicia came to the CDC's attention only after their parents discovered Jenny's blog and Phil Tetlock urged them to file a VAERS report. This system of voluntary reporting of adverse events related to vaccines by doctors and patients is notoriously crude. All too often, adverse events go unreported, whereas many reports that are filed turn out not to be related at all to the vaccines. When I point this out to Iskander, he tells me that while VAERS certainly isn't perfect, it's pretty good at catching rare events.

But what if doctors wouldn ' t think to link the onset of ALS with a vaccination? I press him. "Reports in the media, such as the one you're doing, are a good trigger to get doctors to file reports," he responds. In fact, largely because of media attention, reports of adverse events for Gardasil are about five times as high as the overall average for any vaccine, he adds. So I suppose he's hoping that if there are other girls out there who developed severe physical disabilities after receiving Gardasil, they'll soon be entered into the VAERS database.

Still, I'm troubled by the complexities of all of this. How will the CDC ever be able to know whether there's a true connection between Gardasil and ALS if this disease is so rare? And just how much evidence is needed? Iskander tells me he doesn't make that decision but passes on all the information he has to the government's vaccine working group, which makes recommendations about the national immunization schedule. "They are aware of these cases and that we've started discussions with neurologists and immunologists to determine if there are mechanisms that could explain how a vaccine could cause ALS," Iskander says, adding that "I haven't heard a good answer yet from these experts" when it comes to explaining a mechanism.

Shapiro says her suspicions are raised enough that she's decided not to give her own 11-year-old daughter the Gardasil vaccine. "Let's say it causes just one or two cases of ALS every year out of a million doses that are given. What if your daughter is the one?"

I haven't decided yet whether I want to have my own teenage daughter vaccinated. The arguments for Gardasil are compelling: It protects against viruses responsible for 70 percent of cervical cancers, which still kill many women in this country. Since the vaccine is so new, until more evidence emerges I think it may be prudent for concerned parents to consider holding off until their daughters reach the verge of sexual activity.

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One in four California adolescent girls has had HPV (cervical cancer) vaccine

San Bernadino, CA

A large number of California teens are showing up at medical clinics to receive the cervical cancer vaccine Gardasil, according to a UCLA survey released this week.

Less than two years after the HPV vaccine was approved as a routine vaccination for girls aged 11 and older, one-quarter of the state's adolescent girls have started the series of shots that protect against human papillomavirus, which is strongly linked to cervical cancer.

A majority of the state's teen girls, parents and young women also say they would like to have the vaccine, according to the new policy brief released this week by the UCLA Center for Health Policy Research.

"This is the very first data we have on the use of the vaccine and there appears to be a high acceptance," said David Grant, a sociologist and the survey director. "It's a positive start."

The brief, "One in Four California Adolescent Girls Have Had Human Papillomavirus Vaccination," is an early indicator of how a controversial vaccine is being accepted by the general public, he said.

The vaccine works by provoking the body's immune response to HPV without actually causing HPV infection or any of the diseases.

The vaccine contains inactivated extracts from four different types of the human papillomavirus. These types of HPV cause 70 percent of cervical cancers and 90 percent of genital warts.

The vaccine is administered in a series of three injections over a six-month period
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and targets the HPV types most commonly associated with genital warts and cervical cancer.

There were concerns about the vaccine when it was licensed for use by the Food and Drug Administration in 2006, then recommended for use by the National Centers for Disease Control and Prevention in 2007.

Much of the concern has been about its safety and worries that it might encourage girls to be sexually active.

But as more information on the vaccine has been released, it has become more accepted.

According to the survey, among teen girls in California aged 13 to 17, about 378,000 out of 1,468,000 (26 percent) reported receiving at least one dose of the vaccine.

Among California females aged 18 to 26, about 262,000 out of 2,273,000 (12 percent) reported receiving at least one dose of the vaccine in 2007 and 4 percent had completed the vaccine series.

Among those surveyed who had not yet had the HPV vaccine, not knowing enough about the vaccine was the main reason cited by young adult women age 18 to 26 (31 percent) and parents of age-eligible daughters (54 percent).

Other frequently cited explanations included concerns about the vaccine's safety and questions about its necessity.

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A pearl of wisdom to fight cervical cancer

Chipley, FL

Around 300,000 women die from the disease. And yet, cervical cancer is preventable -; regular screening, along with vaccination, could prevent nearly every case.



To help women protect themselves, the European Cervical Cancer Association (ECCA), along with partners in the United States, recently launched the Pearl of Wisdom Campaign to Prevent Cervical Cancer. The campaign teaches women how to protect their health through regular screening and other measures. The campaign also promotes the Pearl of Wisdom as the global symbol for cervical cancer prevention.



What is cervical cancer? Cancer can develop in any part of the body, including the cervix -; the lower, narrow part of a woman's uterus. The human papillomavirus (HPV), a common, sexually transmitted virus, causes cervical cancer. Most HPV infections go away without symptoms or treatment, but certain high-risk types of HPV can cause the cervix to produce abnormal cells, which can eventually become cancerous.



Why screening? Screening helps find abnormal cervical cells before they become cancerous. When caught early, these abnormal cells can be easily removed to prevent cancer from developing. Cervical cancer doesn't have symptoms until the disease reaches advanced stages, so women should be screened regularly all through their life, even if they feel healthy.



The Pap test looks for abnormal cervical cells. The HPV test detects high-risk types of HPV, which can lead to abnormal cervical cells. In women 30 and older, the Pap and HPV tests together provide the best screening protection against cervical cancer.



Girls and young women can be vaccinated against the two most common cancer-causing HPV types -; 16 and 18 -; which are responsible for about 70 percent of cervical cancers. Studies have shown that vaccination is highly effective at preventing cervical disease. However, vaccination does not protect against all high-risk HPV types. "Even women who have been vaccinated must be screened to protect against cervical cancer caused by the HPV types not included in the vaccines," said Dr. Philip Davies, director of the ECCA.

For more information or to get a Pearl of Wisdom pin to show your support, visit www.PearlofWisdom.us.

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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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Allergic reactions to Gardasil uncommon: study

London

A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday.

The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.

More than 380,000 doses of the vaccine have been given under the program, Sharon Choo of the Royal Children's Hospital in Melbourne and colleagues wrote in the British Medical Journal.

"Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting," they said.

Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.

But skin tests of the 25 girls with suspected hypersensitivity showed that only three of them experienced probable reactions to the jabs.

The researchers also noted that suspected reactions such as hives are often "idiosyncratic" and do not increase the risk of adverse reactions in subsequent shots.

Gardasil and GlaxoSmithKline Plc's Cervarix are designed to be given to girls and young women to protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer.

Gardasil targets four strains of HPV -- two responsible for cervical cancer and two causing the less serious condition of genital warts. Glaxo's product targets the two cancer strains.

In October, the U.S. Centers for Disease Control and Prevention reported that girls and young women given Gardasil were no more likely than usual to faint, have an allergic reaction, blood clot or other adverse reaction.

The report was based on 375,000 doses of the vaccine given from August 2006 to July 2008 after the agency had received 10,326 reports of adverse events following HPV vaccination in the United States.

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New Gardasil cervical cancer vaccination requirement for immigrants stirs controversy

New York, NY

There's no question that it's a hot shot.

Gardasil, the first anti-cancer vaccine ever to come on the market in the U.S., has evoked strong pro and con reactions among parents and some doctors ever since its 2006 FDA approval. It doesn't look like the controversy surrounding it is going to stop any time soon.

Not everyone's happy over the federal requirement that all new female immigrants ages 11 to 26 receive the vaccine, which protects against cervical cancer. The new requirement, which went into effect August 1, will affect more than 130,000 immigrants a year. Cervical cancer causes about 4,000 deaths annually.

The vaccine is expensive, costing several hundred dollars for the required three doses. So far, about a quarter of U.S. teens (about 2.5 million girls) have been given at least one of the three shot series in Gardasil's first full year of distribution, according to the Centers for Disease Control.

Now, immigrants will be required to receive a vaccine that's not even required in this country.

"This is one of the most heartwarming democratic processes I've ever seen," says Dr. William Schaffner, professor and chair of the department of preventive medicine at Vanderbilt University and a member of the CDC's Advisory Committee on Immunization Practices. "Through an interesting quirk, now all these immigrant girls and young women will be protected against cancer. Immigrants will be better protected against cancer than our own population."

The high cost of the vaccine has some medical providers wondering where the funding will come from to administer it.
MORE HEALTH NEWS: FOOD ALLERGIES ON THE RISE FOR U.S. CHILDREN

"If the immigrant has to pay for it, this would be a real burden," says Dr. Jessica Sessions of the Ryan Community Health Center on the Upper West Side, which serves about 40,000 patients per year, many of them low income. "It is a great vaccine but it is extremely expensive for people without insurance."

Gardasil blocks four strains of HPV, two of which cause about 70 percent of cervical cancers. The CDC recommends the vaccine for girls as young as age 11, with catch-up shots up to age 26. It is most effective when given early, before a girl becomes sexually active and might already have contracted the virus that the vaccine blocks – the human papillomavirus, or HPV.

Most medical organizations echo the CDC's advice that Gardasil be part of routine vaccinations, but there have been some concerns about the vaccine's potential side effects. As of June 30, the FDA had received nearly 10,000 reports of adverse reactions following Gardasil injections. Most of the reports described pain at the injection site, fainting, fever and headaches.

Some parents have been reluctant to give their daughters the vaccine because they feel it encourages premarital sex. Dr. Rebecca Booth, a gynecologist and author of "The Venus Week: Discover the Powerful Secret of Your Cycle at Any Age," has administered thousands of Gardasil injections with no serious side effects. She says that exposure to the virus Gardasil protects against is always a matter of personal choice.

"A patient of mine contracted cervical cancer when she was raped," Booth says. "Women who are sexually assaulted can be exposed to the virus. There is a lot of expense, grief, pain and suffering due not just to cervical cancer, but to the precancerous lesions that HPV also causes."

Dr. Schaffner, who calls the vaccine "an extraordinary advance in women's health and the first explicit anti-cancer vaccine," believes that when Gardasil is assessed by the CDC a couple of years out, the findings will be disturbing.

"There will be a disparity in use by income and, as a consequence, by racial and ethnic background," Schaffner says. "More affluent, educated parents will have higher rates of vaccinating their children than parents of more modest means. Will we as a society be satisfied with those kinds of disparities?

"Is it appropriate, in the U.S. in the 21st century, to have substantial portions of its population at risk for cancer of the cervix when we have a vaccine that is safe and effective against 70 percent of all cervical cancer?"

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Merck aims Gardasil to women least likely to benefit

New York, NY

Merck & Co. is targeting its cervical cancer vaccine Gardasil to women who may not benefit from it after U.S. sales shrank in July and August.

The number of Gardasil vaccinations tumbled more than 33 percent in those two months from the year-earlier period, according to health research firm IMS Health Inc. Merck shifted its marketing to women ages 19 to 26, who have been less likely to get the shots. The product, designed to prevent a sexually transmitted virus that can lead to cancer, previously was aimed primarily at young girls most likely to benefit from it.

Harvard University researchers said in an August study that the $400 vaccine isn't cost-effective in the older age group, a finding that supported the American Cancer Society's recommendations. Merck disagrees and says its vaccine can provide a benefit in that age group. Gardasil sales, which reached $1.5 billion in 2007, are slowing because of questions from proposed users on cost, safety and effectiveness, said Seamus Fernandez, a Leerink Swann & Co. analyst in Boston.

``Gardasil needs to be doing better,'' said Barclays Capital analyst Tony Butler in New York, in a telephone interview. The vaccine ``has become increasingly more important from a profit standpoint because of the concerns over Singulair and Vytorin and Zetia.''

Offsetting Vytorin

Merck, of Whitehouse Station, New Jersey, is counting on Gardasil to help offset declining sales of cholesterol pills Vytorin and Zetia after a January study found they may work no better at unclogging arteries than a cheaper medicine. Sales of the asthma treatment Singulair, Merck's top-selling drug, have also slowed over safety concerns.

Merck will report third-quarter earnings on Oct. 22. Second- quarter profit rose 5 percent on higher sales of the diabetes pill Januvia. The company since suspended its 2008 earnings forecast because of plunging Vytorin and Zetia sales.

Gardasil's decline in July and August prompted Fernandez, who rates Merck market perform, to chop $2.8 billion from his revenue estimate for the vaccine over the next five years. The August prescriptions fell 40 percent to 68,330 from a year earlier, according to IMS Health, based in Norwalk, Connecticut. July fell 26 percent to 56,872. Both numbers are probably lower than actual sales because vaccine-market figures are more difficult to collect than those for other types of medicine, said Fernandez.

Merck shares rose 31 cents, or 1.1 percent, to $28.50 at 4 p.m. in New York Stock Exchange composite trading. The drugmaker lost 50 percent of its value this year, the worst performance in the 14-member Standard & Poor's 500 Pharmaceutical Index.

Approval in 2006

The U.S. approved Gardasil in 2006 to protect girls and women ages 9 to 26 against four strains of the sexually transmitted human papillomavirus, which cause 70 percent of cervical cancers and 90 percent of genital warts.

Merck has decided to target the oldest in that group because they're least likely to have been vaccinated during Gardasil's initial availability, said Bev Lybrand, the company's senior vice president of vaccines, in a telephone interview.

``We see tremendous opportunity,'' said Lybrand. ``We have a number of programs under way to get after these women.''

Among women ages 19 to 26, about 15 percent have received the shot, according to a September research report by Merrill Lynch & Co. The U.S. Centers for Disease Control and Prevention in Atlanta reported Oct. 9 that a quarter of girls ages 13 to 17 had gotten at least one Gardasil shot.

Researchers at Harvard, in Cambridge, Massachusetts, said in an August study in the New England Journal of Medicine that targeting the older population will cost the U.S. 50 percent more than what's considered cost-effective.

Best Strategy

The most effective strategy is to target girls before they become sexually active, the study said, supporting the position of the American Cancer Society, in Atlanta, that the vaccine should be given to girls 18 and younger.

The Harvard study found it would cost $150,000 to buy enough Gardasil to extend the life of one person for one year -- $50,000 more than the $100,000 standard that public health officials typically use to judge whether a product cost-effective.

``The push needs to be with the 11- to 12-year-olds,'' said Debbie Saslow, director of breast and cervical cancer for the American Cancer Society, in a telephone interview. ``It is not going to be as effective in the older women.''

Merck says its internal data show the vaccine is cost- effective for women through at least age 24 because only about 1 percent of these women have been exposed to all four types of the virus the vaccine protects against, Lybrand said.

`Firm in Belief'

``Merck is firm in its belief that its efforts are aligned with the scientific data, health economic models and CDC recommendation that support vaccination of Gardasil in females from 11 to 26,'' the company said in an e-mailed statement. ``Many young women are not exposed to all or some of the HPV types for which Gardasil protects, and can still be protected today from getting cervical cancer in their lifetime.''

Merck's $100 million television and print advertising campaign last year featured young girls who were jumping rope and chanting ``one less.'' The company's new ads show college-aged women at home with pop music in the background. Merck spent $60 million on consumer marketing this year through June, according to Nielsen Monitor Plus.

Reaching College Students

Merck is also advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has been selling $32 cervical-cancer awareness charm bracelets on the Internet. Merck is seeking Food and Drug Administration approval to market Gardasil to women through age 45.

``We are starting to see some encouraging feedback,'' Lybrand said.

Merck also wants to persuade more gynecologists to stock the vaccine, she said. The company last month said it would reimburse doctors for the cost of giving patients the vaccine if a health insurer refuses to pay.

``The business is more complex now than it was 10 years ago, so everyone watches the bottom line,'' said Joseph Sanfilippo, vice chairman of reproductive science at the University of Pittsburgh, in a telephone interview. ``Anything to incentivize the physicians with these kinds of programs will be very well received.''

Women over 18 pay for the vaccine either out of pocket or through private insurance, a barrier for many, doctors said. About 10 percent of private insurance plans don't cover Gardasil and few college health plans help pay, Lybrand said. The U.S. government pays for Gardasil for those 18 and younger who don't have insurance.

Question of Cost

``Merck will point out that there are individual women who haven't been exposed,'' said Saslow of the American Cancer Society. ``I would say there are also women in this age group who can't afford to buy food. If you want to get the vaccine, fine. But think about where you are financially.''

Merck's challenge to increase sales may intensify next year when GlaxoSmithKline Plc, of London, hopes to begin selling in the U.S. a similar vaccine called Cervarix.

Gardasil also faces opposition from nonprofit groups, some of which advocate sexual abstinence before marriage, that say Gardasil may not be safe and gives women false security about sexually transmitted diseases.

The CDC said it has received reports of 21 deaths and almost 10,000 side effects in women following vaccination. None of the deaths could be linked to the vaccine and 94 percent of the side effects were ``non-serious,'' such as soreness around the injection site and headaches, the CDC said.

Cervical cancer killed 3,850 women in the U.S. in 2004, and treating it costs more than $2 billion each year, according to the CDC.

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25% of teen girls vaccinated for cervical cancer, U.S. says

Los Angeles, CA

The CDC calls the rate 'very good' for a new vaccine such as Gardasil. Earlier data show, however, that only about 1% of Latina teens have received it.

About a quarter of the nation's teenage girls received the controversial cervical cancer vaccine Gardasil last year in its first full year of distribution, federal authorities said Thursday.

"For a new vaccine, 25% is really very good," Lance Rodewald, director of the division of immunization services at the Centers for Disease Control and Prevention, said in a telephone news conference releasing the data.

"We need to see that rate every year if we are going to meet our goal" of having 90% of teenagers vaccinated, he said.

But immunologist W. Martin Kast of USC's Keck School of Medicine said, "Twenty-five percent is not bad, but it's not good either."

He said data released earlier in the year by Gardasil's manufacturer, Merck & Co., show that only about 1% of Latina teens were receiving the vaccine, and "they are the population that needs it the most" because the frequency of infection is relatively high.

Researchers said the percentage of teens receiving two other relatively new vaccines also went up. About 32% of teenagers received the meningitis vaccine, up from 20%; and 30% received the tetanus, diphtheria and whooping cough vaccine, up from 19%.

CDC recommends that girls get the cervical cancer vaccine and that all children get the other two when they are 11 or 12.

Merck received Food and Drug Administration approval to begin marketing Gardasil in June 2006. Experts say it spent $100 million marketing it in 2007 and had sales of about $1.5 billion.

The vaccine protects against four strains of human papilloma virus that account for about 70% of all cases of cervical cancer in the United States.

But the vaccine has been criticized on a number of fronts. Some scientists argue that it is only modestly effective and that its safety has not been adequately proved. Conservative groups say that giving it to young girls implies approval of sexual activity. And consumer advocates bemoan its high price -- $360 for a series of three shots.

The data, published in CDC's Morbidity & Mortality Weekly Report, came from the second year of the agency's annual National Immunization Survey for Teens. Researchers conducted telephone interviews with a representative sample of nearly 3,000 teens ages 13 to 17, then confirmed their answers with vaccination records from physicians.

They found that 25.1% of girls in the group had received at least one dose of the vaccine, which translates to about 2.5 million of the country's 10 million girls. Only a quarter of that group had received all three recommended doses, but officials noted that the series takes six months and many girls had not had time to complete it.

Results are unlikely to be as good this year, however. Merck reported sales were down 9% in the second quarter, and IMS Health Inc., which monitors drug use, said U.S. sales were off 34% in July and August, probably as a result of the faltering economy.

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Cervical cancer HPV vaccine on the rise

Gainesville, FL

Gardasil is the only cervical cancer vaccine that helps protect against four types of human papilomavirus. The vaccine was introduced two years ago and recommended that all women between the ages of nine and 26 recieve the vaccine. Director of Student Health Care Center at the University of Florida Phillip Barkley has seen the effects at the Student Health Care center since the vaccine was introduced. Though the vaccine is most effective before women are sexually active, it is still recommended that sexually active women receive the vaccine to help prevent against other forms of H-P-V. Doctors recommend that young women between the ages of nine and twenty six receive the vaccine. However, 11 to 12 year old girls are the best candidates for the vaccine. The vaccine is given in a series of three shots throughout a 6 month period. The vaccine has proved to be most effective when all three shots have been given on time. Since introduced two years ago, there have been concerns about the vaccine. The lifetime, cost, and side effects of the vaccine are all concerns that doctors have been trying to resolve. The vaccine is offered for all female students at the Student Health Center. This vaccine is something Dr. Barkley recommends strongly to all women. He believes it has a strong chance of preventing young women from being diagnosed with cervical cancer. Although the vaccine could prevent up to 70 percent of cervical cancer cases, it can't prevent infection with every virus that causes cervical cancer. Routine Pap tests to screen for cervical cancer remain important.

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Even if you've had HPV cervical cancer vaccine, Pap smears are still necessary

Fredricksburg, VA

SINCE its introduc- tion in 2006, the human papilloma virus (HPV) vaccine has been given to millions of girls and women between the ages of nine and 26. As a result, the incidence of abnormal Pap smears is already on the decline. And the number of follow-up tests--such as cervical biopsies--and treatments--like cryotherapy--is also declining.

This is great news, but it shouldn't lull women into a sense of complacency.

HPV, as the name indicates, is a virus. It is passed from one person to another by direct contact, like sexual intercourse.

Once a person is exposed to the HPV virus, one of three things can happen:

The immune system may get to work clearing the virus from the body, and it will never cause any problems.

The virus may enter the cells of the external genital organs like the vulva, vagina or cervix and just lie dormant, causing no detectable disease for an indefinite period of time.

Or, the virus may cause changes to the cells it inhabits that can lead to pre-cancer or, over time, cancer.

PAP SMEAR POWER

There are about 40 different types of HPV that can infect the human genital tract. The current HPV vaccine protects against only four: the two types that cause approximately 90 percent of genital warts, and the two types that cause 70 percent of cervical cancers.

That means that this vaccine does not protect against HPV types that cause the other 30 percent. There's a new HPV vaccine coming down the pike that will cover more types, but it still won't cover all 40.

It's important to understand that just because you've had the HPV vaccine, this doesn't mean that you can be lax about having Pap smears. Even for the vaccinated group of women, Pap smears are still a very important tool for the early diagnosis of pre-cancer and cancer of the cervix.

So, what are the most recent recommendations for cervical cancer screening?

First of all, Pap smear testing should begin at least three years after the onset of sexual activity or at 21 years of age, whichever comes first. After this, Pap smear testing should occur yearly until the age of 30.

Read more, "Even if you've had HPV cervical cancer vaccine, Pap smears are still necessary"

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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 Times

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?

Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer, some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive for use, cervical cancer is classified as very rare in the West because it is almost always preventable through regular Pap smears, which detect precancerous cells early enough for effective treatment. Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway.

“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,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.

“In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”

Dr. Richard Haupt, medical director at Merck, said the vaccine had not been rushed into use, saying that five years in clinical trails was normal before applying for licensing. He said Merck educated physicians, politicians and the public about the new vaccine to “accelerate and facilitate access.”

Spokesmen for Merck and Glaxo say all indications are that their vaccines are safe and effective, and there is no evidence that a booster shot will be needed. A Glaxo spokeswoman, Sarah Alspach, said its formulation produces a “stronger and longer-lasting immune response” than conventional vaccines.

Continue reading, "Drug makers’ push leads to cancer vaccines’ rise"

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Cervical cancer vaccine Gardasil linked to Pancreatitis

Palm Peach, FL

Gardasil, the cervical cancer vaccine, which is being advised for all young women, may be causing pancreatitis, a painful, debilitating disease that can be fatal. Australian sources reported that three women developed pancreatitis shortly after receiving the vaccine.

Gardasil protects women from strains of the HPV (human papillomavirus) that cause 70 percent of all cervical cancer. But numerous cases of young women being stricken with various potentially deadly complications have arisen all over the world. Eighteen deaths have been reported as well as 8,000 adverse reactions which include paralysis and seizures. Australia alone reported over 1,000 suspected reactions to the vaccine, although most were not life-threatening and included headaches, dizziness and vomiting.

Acute pancreatitis is characterized by sudden, severe abdominal pain. Pancreatic enzymes burn and irritate the pancreas, then leak out into the abdominal cavity. Complications can include heart, respiratory or kidney failure, all of which can be fatal.

Dr. Amitabha Das, writing in the Medical Journal of Australia, said, “We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination.

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New Harvard study shows cervical cancer vaccine Gardasil worth the cost

Washington, D.C.

According to a new study released by Harvard researchers, the cervical cancer vaccine Gardasil is well worth the cost to protect girls against the virus.
Harvard researchers took part in a study which looked at just how cost-effective the cervical cancer vaccine Gardasil actually was.
What they found was that the most cost-effective way to fight the virus using Gardasil would be to vaccine all 12-year old girls.
Beyond that, you would also have to immunize all women under the age of 21, and revise screening guidelines.
Their study on how cost-effective the cervical cancer vaccine is has been published in the August 21 issue of the New England Journal of Medicine.
The cervical cancer vaccine Gardasil helps protect against two strains of HPV, which are responsible for 70% of cervical cancer cases around the world.
Gardasil was approved back in 2006 and was recommended by the CDC for girls who are ages 11 or 12-years old.
The Harvard researchers also found that the cervical cancer vaccine may not be as cost-effective for older women, over the age of 21.

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Wall Street Journal: Study questions cost-effectiveness of Gardasil cervical cancer vaccine

From The Wall Street Journal

A new study suggests that giving Merck & Co.'s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot.

The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen. This has contributed to a slowdown in Gardasil sales, casting a cloud on Merck's financial outlook.

Questions surrounding Gardasil's cost-effectiveness also could make for tougher market conditions for GlaxoSmithKline PLC's Cervarix, a cervical-cancer vaccine that is available outside the U.S. and is under review by the U.S. Food and Drug Administration.

Gardasil is designed to prevent infection by four strains of the human papillomavirus, or HPV, which is transmitted through sexual activity. Two of the targeted HPV strains are believed to cause about 70% of all cervical-cancer cases, while the other targeted strains cause most cases of genital warts. HPV also can cause other, rare tumor types such as vaginal and anal cancers. Gardasil isn't guaranteed to prevent cervical cancer because it doesn't protect against certain cancer-causing HPV strains.

The FDA approved Gardasil for use in females ages 9 to 26. The Centers for Disease Control and Prevention recommends routine HPV vaccination for girls 11 and 12 years old, as well as a temporary "catchup" vaccination for girls and women ages 13 through 26 who were never immunized. The CDC says it's ideal to get vaccinated before becoming sexually active, but vaccination after becoming sexually active can still offer protection because girls and women may not become exposed to all four HPV strains for many years. The vaccine doesn't treat existing infections, however.

The study published by researchers from the Harvard School of Public Health suggests Gardasil's cost is justified in pre-adolescent girls, partly because they are less likely to have already been exposed to HPV. But among older females, the cost-effectiveness of Gardasil becomes less and less favorable, researchers concluded. "Under most scenarios, extending the catchup to 26 wasn't cost-effective," Jane Kim, an assistant Harvard professor, said in an interview.

Merck, Whitehouse Station, N.J., disputed the conclusions, saying its own health-economic models suggest the vaccine is worth the cost. "We believe there's important value in vaccinating all women who are in the indicated age groups," said Rick Haupt, Merck's head of clinical research for Gardasil.

Ms. Kim and Harvard colleague Sue Goldie concluded that it cost about $43,600 per "quality-adjusted life year" gained, when HPV vaccine is administered to 12-year-old girls. This falls below the $50,000 per quality-adjusted life year threshold that some researchers use as a maximum for cost-effectiveness. Other researchers use a higher maximum benchmark of $100,000 per QALY to gauge cost-effectiveness.

It would cost $97,300 per QALY, however, to vaccinate girls and women through age 18, $120,400 per QALY for girls and women up to age 21, and $152,700 for girls and women up to age 26. The cost-effectiveness becomes more attractive when protection against genital warts is factored in.

The researchers arrived at these numbers by projecting HPV infection rates in various age groups, gauging the effectiveness of the vaccine and estimating cervical-cancer screening rates. Screening via Pap smear is recommended for women who are sexually active, even with the availability of Gardasil. The screenings can detect pre-cancerous lesions that can be removed; the availability of these tests has helped reduce the cervical-cancer death rate in the U.S. dramatically since the 1950s.

Merck's Dr. Haupt said the company's own models show that the cost per QALY is "well under $50,000" for women up to age 26. Among the differences between the models were that the Harvard researchers included patient time and travel costs, while Merck didn't, and the Harvard researchers didn't include genital warts in males, while Merck did, according to the CDC.

At least one of the factors in the primary Harvard calculations may be a relatively optimistic assumption -- that vaccination would produce lifelong immunity. Because the vaccine was only studied for five years and has been on the market for two years, no one knows for certain if its protection is lifelong, or if it wanes over time.

The Harvard researchers concluded that the cost per QALY would rise if the vaccine's effect wanes after 10 years.

Merck says the vaccine will offer protection well beyond five years, Dr. Haupt said. The Merck economic model that arrived at the cost per QALY below $50,000 assumed lifelong immunity, he said.

Still, the study is likely to fuel skepticism about Gardasil, which has already faced questions surrounding its safety and effectiveness (Merck and the CDC maintain it is safe and effective, with the most common side effect being soreness at site of injection.)

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