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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Free cervical cancer screenings offered in Valdosta, Florida

Tallahassee,FL

South Georgia Medical Center invites all women who have not had a pap smear in at least three years to get one for free tonight at the Pearlman Cancer Center.

The American Cancer Society says more than 11,270 new cases of invasive cervical cancer were detected last year.

Doctors encourage women to keep up with regular screenings.

"Pap smears actually detect pre-cancerous legions, which is a great advantage in the sense of heading off cancer," said Dr. Boland Woodward, an obstetrician-gynecologist with Southern OB/GYN in Valdosta.

Screenings and breast exams are being offered today at the Pearlman Cancer Center until 7 p.m. But the latest is that they're full with pre-scheduled appointments. And walk-ins will no longer be offered tonight.

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Importance of Pap Smear Test cervical cancer screening emphasized by Missouri doctor

Osage Beach, MO

During Cervical Cancer Screening Month and Cervical Health Awareness Month in January, physicians with Lake Regional Health System in Osage Beach, Mo., are encouraging women and parents of young girls to learn more about early detection and prevention.

“It’s important that women know about this disease,” said Gynecologist Becky Simpson, M.D., with Lake Area Women’s Center in Osage Beach. “It can be treated if detected early, and most cases now can be prevented.”

According to the American Cancer Society, nearly 12,000 U.S. women are diagnosed with cervical cancer each year, and about 4,000 die from it. However, more lives are being saved thanks to increased use of the Pap test — the screening procedure used to find changes in the cervix before cancer develops — and a recently approved vaccination.

Almost all cases of cervical cancer are caused by the Human Papillomavirus — the most common sexually transmitted disease. If an HPV infection isn’t treated or doesn’t clear on its own, it eventually can result in cervical cancer.

“The fastest, easiest way to detect HPV is through an annual Pap test,” Dr. Simpson said. “During this test, we take a sample of cells from the cervix, which is the bottom part of the womb. The cells then are examined for abnormalities or infections, which can be early signs of cancer.”

If an HPV infection is detected and the abnormal cells are treated early, most cases of cervical cancer can be prevented. For this reason, doctors recommend annual Pap tests and pelvic exams for women ages 18 and older, or those who have become sexually active.

Doctors also encourage women ages nine to 26 to get vaccinated against HPV. The vaccine, Gardasil, is a series of three vaccines. They help protect against four types of HPV, two of which cause 70 percent of cervical cancer cases.

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U.S. experts mixed on whether HPV Test should replace Pap Smear Test to diagnose cervical cancer

Norwalk, CN

DNA testing for the human papillomavirus should replace the Pap smear as the main way to screen women for cervical cancer, according to Italian researchers.

Their recommendation is based on a study that found that the human papillomavirus (HPV) test prevented more cases of cervical cancer than the conventional Pap smear. Results of the study were published online Jan. 19 in The Lancet Oncology.

The HPV test should become the screening tool of choice for women 35 and older, the researchers said. It could be done less frequently than the Pap test, which could be used only in women who have tested positive for HPV, they said.

The Pap smear, first introduced in the 1950s, looks for changes in the cervix that could lead to cervical cancer. The HPV test works a step further back in the process, looking to see if women are infected with HPV.

HPV causes cervical cancer, which remains a significant health problem, particularly in less resource-rich areas of the world.

DNA testing for HPV, though, does have drawbacks -- namely that it is less specific, meaning it is likely to pick up more false-positives, than a Pap smear. This results in many more callbacks for women to undergo further testing.

Using HPV as a primary screening tool results in a callback rate of about 25 to 30 percent, said Dr. Mark Einstein, a gynecologic oncologist and director of clinical research at Montefiore Medical Center in New York City. By contrast, Pap smears have a callback rate of about 5 to 7 percent, he said.

For their study, the Italian researchers compared HPV testing alone with HPV testing plus a Pap smear in 94,370 women aged 25 to 60 years old.

During the first phase of the study, women 35 to 60 who tested positive for HPV were given a cervical examination, called a colposcopy. Younger women got a colposcopy if their Pap smear was abnormal or if HPV results were positive several times, indicating that their body had not been able to clear the infection.

Screening for HPV DNA appeared more effective in older women, but the testing in younger women led to over-diagnosis of a particular type of cervical lesion, the study found.

Not all experts agree, though, that current practice would change based on the study's findings alone.

"I don't think this is going to change any strategies we do now, but I do think it's more evidence that HPV testing can predict who's going to develop cervical cancer," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "HPV testing, in certain populations, can really predict who would benefit from treatment."

Einstein had a somewhat different take on the findings. "This shows that the strategy does work," he said. "It does make sense, it's cost-effective and effective. This is happening in single-payer health systems which have national screening. We're behind in the U.S."

The strategy makes particular sense in less-developed countries, where women could do an HPV test themselves with a "self swab" and then send the swab in for analysis, Einstein said.

In the United States, cervical cancer screening guidelines were changed in November. Women now are being told that they should get their first screening for cervical cancer -- including a Pap test -- at age 21. The previous recommendation was to start Pap tests three years after becoming sexually active or at age 21, whichever came first.

And, rather than have an annual Pap test, most women need to be screened every other year or less, depending on their age, according to the new guidelines.

Cervical cancer rates have dropped more than 50 percent in the last 30 years in the United States, according to the guidelines. That decline has been largely attributed to widespread use of the Pap test.

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Cervical Cancer and HPV: What you should know

Savannah, GA

January is National Cervical Cancer Awareness Month, and the American Cancer Society estimates that 11,270 new cases of cervical cancer will be diagnosed and about 4,070 women will die from it here in the United States.

The number of deaths caused by cervical cancer has declined significantly mostly because of the use of the Pap test (Pap smear). However, the disease still remains a serious threat especially in African American, Hispanic and Asian women as well as in women who are low income and have no insurance. Cervical cancer is easy to prevent and highly curable when detected and treated early.

What is cervical cancer? Cervical cancer is cancer that starts in the cervix, which is the lower part of the uterus or the womb. Usually the cancer grows slowly and many women do not know they have the disease because they do no have any symptoms.

The main cause of the disease is a virus called human papillomavirus (HPV), which is spread through sex and causes changes in the cervix. Almost 99% of all cervical cancers are caused by HPV. Most HPV infections do not have symptoms and most people do not even know they are infected. Majority of the time, HPV infections clear up on its’ own and do not cause cancer. However, if the infection does not go away, it can cause the normal cells in the cervix to become precancerous. Pre-cancer cells do not always turn into cancer and most will return to normal. If they are not found and treated, the precancer cells may turn into cancer.

The only way to fully prevent HPV infection is through abstaining from sexual activity. Another way to prevent infection is through the HPV vaccine, which was approved by the Food and Drug Administration in 2006. The vaccine protects against HPV types 16 and 18, the two types that cause 70% of cervical cancer. The vaccine is recommended for girls and women ages 11 to 26. The American Cancer Society recommends that women talk to their doctor about whether the vaccine is right for them.

All women are at risk for cervical cancer. There are certain risk factors that increase a woman’s chance of getting the disease. In addition to HPV infection, other risk factors include smoking, having HIV or any disease that affects the body’s immune system, Chlamydia infection, and long-term use of birth control. Having multiple sexual partners and having sex at an early age may also increase the chances of getting cervical cancer. Early detection is the key to preventing and treating cervical cancer. Cervical cancer screening using the Pap test is the most effective and reliable form of prevention. Getting regular Pap tests can save your life. The Pap test locates pre-cancer and abnormal cells that may become cancerous if not found early and left untreated. The HPV test can also be used to find change in the cells in the cervix.

Some simple guidelines for cervical cancer screening by the American Cancer Society are as follows: All women should begin getting annual Pap tests about 3 years after they become sexually active but no later than age 21; starting at age 30, women who have had normal Pap tests 3 years in a row should get screened every 2-3 years; women 70 years or older who have had normal Pap tests at least 3 years in a row and no abnormal tests in the last 10 years can stop being screened; however, you should talk to your doctor or other healthcare professional to determine how often you should have a Pap test.

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Cancer Centers of the Carolinas honors Cervical Cancer Month by building awareness

Greenville, SC

January is Cervical Cancer Month, a time set aside to raise awareness of cervical cancer. In the United States, approximately 11,270 women will be diagnosed with cervical cancer in 2010. However, invasive cervical cancer is highly preventable. That’s why Cancer Centers of the Carolinas (CCC) is making it their goal to stress the importance of regular Pap tests in preventing cervical cancer, the role of Human Papillomavirus (HPV) infections in the development of the disease and treatment options if abnormal cells are detected.

The National Cancer Institute (NCI) says that failure to get a Pap test, as well as failure of the test itself, are common for women who have been diagnosed with cervical cancer. In fact, 60 to 80 percent of the women who are newly diagnosed with cervical cancer in the United States report they have not had a Pap test in the past five years. According to the NCI, the key to preventing death from cervical cancer is regular screening to detect abnormalities in the cells of the cervix early, before they become cancerous.

CCC is committed to helping women in the Upstate and their families win the battle against cervical cancer. They do this by providing easy access to a full range of advanced cancer care services
in a community-based setting that allows patients to remain close to home and their support networks of family and friends. CCC strongly believes in this comprehensive community-based approach to the management of their patients’ cancer treatment and follow-up care.

CCC has oncologists who use the latest advances in technology and therapies to deliver complete and compassionate care. As experts in cancer, CCC is a leader in research and participates in many clinical trials that result in new therapies for patients battling cervical cancer.

Serving Upstate communities for more than three decades, Cancer Centers of the Carolinas (CCC) is a community-based, physician-owned practice with 28 board-certified oncologists practicing in multiple locations across the Upstate of South Carolina.

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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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Cervical cancer deaths may be cut by 100k per year in poor nations with new screening test

London, UK

A simple "see and treat" approach using a test costing $2 could help doctors prevent 100,000 cervical cancer deaths a year in women in poorer countries, British scientists said on Friday.

Cervical cancer is the leading cause of cancer death among women in developing nations where the main barriers to tackling the disease are poor health service infrastructure and high costs of screening and vaccines.

But British researchers said visual inspection with acetic acid (VIA) -- which costs significantly less than $9 human papillomavirus (HPV) or cervical cell lab tests more commonly used in developed nations -- could be the answer.

Around 300,000 women worldwide die from cervical cancer each year and up to 85 percent of those deaths occur in developing countries.

"VIA is an effective and affordable tool to screen women for pre-cancerous lesions of the cervix in under-resourced countries," said David McGregor of University College London, who led the research.

"Coupled with simple treatment measures, VIA could potentially reduce these cancer deaths by a third, which means nearly 100,000 women saved each year."

VIA is a simple test where a very small dose of acetate acid solution is applied to the cervix to detect pre-cancerous lesions. A positive result can be treated immediately.

This is referred to as the "see and treat" approach and experts say it can work well in small clinics without advanced equipment and laboratories.

Drug firms Merck & Co and GlaxoSmithKline make Gardasil and Cervarix vaccines which protect against a number of strains of HPV -- the most common sexually transmitted disease in the world and the main cause of cervical cancer.

But unlike in developed nations, where cervical screening programs are well established and vaccination programs against HPV are growing, access to tests and vaccines in many countries in Africa, Asia and southern America is limited.

The study in the Obstetrician & Gynecologist journal said research in rural and isolated communities had shown that VIA is accurate, acceptable to women, and cuts cancer death rates.

But it said raising awareness about screening programs to ensure higher uptake in the population was also a challenge.

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Don't skip cervical cancer screenings

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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HPV infects 56% of young lovers, new study finds

Montreal, Canada

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

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

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

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

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

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

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

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

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

The CDC addresses health concerns about the vaccine.

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

New York, NY

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

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

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

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

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

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One out of 142 girls in Missouri will have cervical cancer

Jefferson City, MO

The Missouri Department of Health says Missouri is ranked fourteenth in the world for new cases of cervical cancer. One in 142 girls born today will be diagnosed with cervical cancer sometime in life. It is about 240 people in Missouri.

Cervical cancer is mostly caused by contracting Human Papilloma Virus, or HPV.

Health Department Nurse Susan Kneeskern says children need to be vaccinated before they become sexually active. The three-dose series should be introduced from age nine to 11 or 12, the department recommends.

Kneeskern said, “The vaccine can be administered to females up to age 26, but those who are sexually active could get less benefit from it since they might have already gotten one or more types of HPV type targeted by the vaccine.”

Two HPV vaccines are FDA-approved and these are Gardasil from Merck, produced in yeast, and Cervarix from GlaxoSmithKline, produced in insect cells, till date.

Dr Santos, a gynecologic oncologist, said even after women get vaccinated they will undergo screening with HPV DNA testing or biomarker testing at around 30 years.

HPV is the leading cause of cervical cancer in women.

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January is Cervical Health Awareness Month

Courtesy National Cervical Cancer Coalition

Somewhere around 11,000 new cases of cervical cancer will be diagnosed among American women in 2010. An estimated 4,000 women will die from this disease, the only cancer known to be exclusively caused by a common virus, the Human Papillomavirus (HPV). High-risk HPVs may cause cases of mouth, head and neck cancer as well, according to research recently completed.

Other than those practicing lifelong abstinence, most adults acquire an HPV infection during their lifetimes. But mostly the infections turn out harmless and dissappear on their own.

Other infections persist and if they remain untreated for years, or even decades, may lead to cancer. Precancer detection is essential for treatment to prevent the development of cancer. Get a Pap test regularly from a gynocologist in order to detect when HPV causes cells to change long before they progress to cervical cancer.

Regular screening is still recommended despite any new information coming out. Cervical cytology screening is recommended for women every two years beginning at age 21.

The National Cervical Cancer Coalition (NCCC) founded in 1996, is a grassroots nonprofit organization dedicated to serving women with, or at risk for, cervical cancer and HPV disease. For more information visit the Web site at www.nccc-online.org.

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Having sex at an early age can double risk of cervical cancer

London, UK

A study shows women are at greater risk from the disease by becoming sexually active at a young age, prompting campaigners to call for the screening age limit to be lowered

The study published in the British Journal of Cancer into why poorer women have a higher risk of the disease found they tended to have sex four years earlier than more affluent women.

In England, women do not qualify for NHS screening until they reach 25, perhaps ten years after they may have contracted HPV, the sexually transmitted virus that causes most cases of cervical cancer.

The age at which a woman had her first baby was also an important factor, according to the study of 20,000 women by the International Agency for Research on Cancer.

But smoking and the number of sexual partners did not account for any of the difference.

Dr Silvia Francheschi, who led the study, said the risk of cervical cancer was higher in women who had their first intercourse aged 20, compared with 25.

She said: “In our study, poorer women become sexually active on average four years earlier. So they may also have been infected with HPV earlier, giving the virus more time to produce the long sequence of events that are needed for cancer development.”

Women aged between 25 and 49 are offered checks every three years in England, while women aged 50 to 64 get five yearly checks for pre cancerous changes that could develop into cancer without treatment.

Dr Lesley Walker, of Cancer Research UK, said: “These results back up the need for the HPV vaccination to be given in schools at an age before they start having sex, especially among girls in deprived areas.”

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Early detection is key to prevent cervical cancer

Recent Pap test recommendations and new vaccine approvals have brought cervical cancer screening into the spotlight and may have some women confused about what to do to protect themselves. Experts agree that routine screening is essential in the fight against cervical cancer, which is entirely preventable because it has a known cause-"high-risk" types of the human papillomavirus, or HPV.

According to the American Cancer Society, more than 11,000 women in the U.S. are diagnosed with cervical cancer each year. Eight out of 10 women are estimated to get HPV at some point in their lives, but the virus usually goes away on its own. However, infection with certain high-risk types of HPV may persist in some women and cause abnormal cells to develop into cervical cancer.

"We now have a full range of tools to protect future-and current-generations of women from developing cervical cancer, including vaccines, the Pap test and the HPV test," says Dr. Marie Savard, ABC News Medical Contributor and author of "Ask Dr. Marie: Straight Talk And Reassuring Answers To Your Most Private Questions." "Each tool has its own distinct function, so it's important to know the age recommendations, differences and how the tools can be used together to prevent cervical cancer."

Advances In Cervical Cancer Prevention

Screening technologies such as Pap and HPV testing allow for early detection of cervical cancer, while vaccines for girls and young women ages 9-26 can prevent future infections with certain cancer-causing HPV strains. Recently, the American Congress of Obstetricians and Gynecologists changed its Pap test screening recommendations to begin at age 21 and continue every other year. These new guidelines also say that women 30 and over can have a Pap test every three years when the Pap is "normal."

Doctors use Pap and HPV tests to determine a woman's risk for cervical cancer. A Pap looks for abnormal or precancerous cells caused by HPV, while the HPV test detects high-risk strains of the virus itself. HPV testing, performed together with the Pap in women age 30 and older, identifies women with high-risk HPV infections that can cause cervical cancer, enabling diagnosis and treatment to be put in place before cervical disease develops.

For women age 30 and older, who are at the greatest risk for cervical cancer, both tests can be performed at the same time and are covered by most insurance plans. Women with abnormal Pap results or who test positive for high-risk HPV should be monitored more closely by health care professionals so that any cell changes can be tracked and treated-before they can become cervical cancer.

"I had barely heard of HPV and yet here I was, diagnosed with cervical cancer at age 34," says Lori Stone, a cancer survivor and founder of the Pacific Northwest Cervical Health Coalition. "After years of normal Paps, an HPV test called the digene HPV Test alerted my doctor to do more follow-up, and we were able to catch my cancer at a stage when it was still very treatable."

Early detection of abnormal cervical cells is key so you can be closely monitored and treated accordingly. Take an active role in cervical cancer prevention! Be your own best advocate-ask your doctor what prevention tools are right for you: Pap testing, HPV testing and HPV vaccination.
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New cervical cancer screenin guidelines "surrounded by confusion"

Wilmington, NC

Video

Doctor Sandra Hall has been busy fielding calls from patients concerned about new pap smear and mammogram recommendations. Last week, a government task force said women should not start getting mammograms at age forty - instead, they should wait until they turn fifty.

“They said from age 40 to 49 that benefit was small, they would have to screen 1,900 women to save one woman's life compared to age 50 to 59 where you'd have to screen about 1,300 women. They're not saying there isn't a benefit; they're saying it's small,” explained Dr. Sandra Hall.

While that was sinking in, women under thirty were then told annual pap smears were no longer needed. They were told that an exam every two years would be enough to catch slow-growing cervical cancer.

Dr. Hall said, “It can take ten, sometimes 20 years to grow. We know a lot more about cervical cancer these days, about the HPV virus that causes cervical cancer, and it isn't women being screened dying from cervical cancer, it's women who aren't being screened.”

Still, Doctor Hall said it is important to remember this task force is made up of people who aren't oncologists, treating cancer on a regular basis. These recommendations do not apply to everyone, especially if you have ever had an abnormal pap smear or a history of cancer in your family.

“I think the most important thing is to talk to your doctor. Your individual risk is so important and these are general recommendations, they're not mandates,” added Dr. Hall.

So even though it is now recommended that women under thirty, who have never had an abnormal pap smear, wait two years between tests, Doctor Hall said you still need a pelvic exam every year.

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Will cutting back on teen Pap tests result in more STDs?

Atlanta, GA

Teen girls can skip Pap tests, according to new guidelines that say women should start cervical cancer screening at age 21. But some experts are concerned that rates of sexually transmitted diseases or unplanned pregnancies could increase without the Pap test to prompt a doctor's visit.

As it stands, as many as one in four U.S. teenage girls has had an STD at some point in her life, often soon after she becomes sexually active, according to research published this week in Pediatrics.

"I am concerned that without the recommendation for young women to get Pap smears early on, they will lose important opportunities to seek advice and to learn about their health -- particularly their sexual health -- at a time in their lives when they need it most," says Kimberly Spector, an adolescent-health educator in Los Angeles, California. "Regardless of the tests performed during a gynecologist visit, the conversation regarding sexual health risks and preventative measures can be very informative and empowering for young patients."

In the past, women were told to start Pap tests, which can detect abnormal cells in the cervix, three years after becoming sexually active or at age 21 -- whichever came first. However, these abnormal cells often go away on their own, particularly in young women. If they don't, such cells grow so slowly that catching them at age 21 is still early enough to remove them before they become cancerous. And catching them sooner could lead to unnecessary tests and treatments that sometimes damage the cervix, increasing the risk for a premature birth later in life.

The new guidelines still recommend that girls who are under 21 see a gynecologist; they just don't need Pap tests, according to the American College of Obstetricians and Gynecologists. The fear, however, is that some teens may misinterpret the new rules and miss out on important discussions about contraception and protection against STDs such as gonorrhea, bacterial vaginosis, chlamydia, and human papillomavirus.

"If women hear that they no longer need Pap tests annually or until they are 21, perhaps they wouldn't seek any preventive health care, and whether this results in decreased screening and identification of chlamydia and other STDs remains to be determined, but it is concerning," says Harold Wiesenfeld, M.D., the director of the division of reproductive infectious diseases at the University of Pittsburgh School of Medicine, in Pennsylvania.

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Many STDs, including chlamydia and gonorrhea, have no symptoms. "Unless screened, young women will remain undiagnosed, untreated, and at risk for complications, including pelvic inflammatory disease, which results in infertility," says Wiesenfeld, who is also an associate investigator at Magee-Womens Research Institute, in Pittsburgh. "[Still] the Pap test is not the 100 percent trigger to do chlamydia screening," he says. "We need to do a better job about STD screening overall."

Teens who are sexually active should use contraception and take steps (such as using condoms) to prevent STDs, even if they don't need Pap tests, says Alina Salganicoff, Ph.D., the vice president and director of women's health policy for the Henry J. Kaiser Family Foundation, an advocacy group based in Menlo Park, California.

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"We are going to have to pay special attention to how we educate our adolescent patients about contraception and STD prevention," she says.

However, most experts agree that Pap tests are indeed unnecessary for younger women and that the new guidelines will not put them at risk. Most also agree that the new guidelines are not an effort to limit care.

"I do not fear the consequences because these guidelines are well thought out and give us a great opportunity to focus on who is at risk for cervical cancer," says Bobbie Gostout, M.D., the chair of the department of obstetrics and gynecology at the Mayo Clinic, in Rochester, Minnesota.

"Cervical cancer screening is very important, but we are getting smarter at screening," she says. "We are backing off from screening those that have less to gain from it." The cervical guidelines, which recommend that sexually active teens still be counseled and tested for STDs (although a pelvic exam might not be necessary), "hit it right," she says.

Teens who have received human papillomavirus vaccines, such as Gardasil, are protected against several HPV strains that are linked to many, but not all, cervical cancers and to genital warts. These types of vaccines may eventually reduce cervical cancer rates even further (rates have been dropping since the 1970s), although experts say the impact won't be seen for 10 to 15 years. Therefore, girls and women given the HPV shot need to have Pap tests starting at age 21 and every two years after that, just like those who haven't had the shot.

The Centers for Disease Control and Prevention has added Gardasil to its routine childhood vaccine schedule. It recommends that Gardasil, which is administered in three doses, be given to all girls ages 11 and 12, and even for girls as young as 9, with catch-up doses for girls and women ages 13 to 26 who haven't been vaccinated.

"We know that the HPV types targeted by the new vaccine are linked to cervical cancers that tend to occur five years earlier than cervical cancers caused by other HPV types," Gostout says. "So once adolescents are well vaccinated against HPV, we should have even more confidence in eliminating Pap tests in younger women."

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"We are now rolling out the vaccine, and clearly the first group that will experience broader protection is young women," agrees the Kaiser Family Foundation's Salganicoff. "The HPV vaccine is a really important step that young women can take in terms of protecting themselves against HPV and subsequent cervical cancer."

Ideally, teens should have an HPV shot and see a gynecologist for counseling about STDs before they become sexually active, experts say. HPV vaccines don't protect women who have already been infected with the virus.

"Ideally, women need to establish a relationship with a reproductive health provider before they become sexually active," Wiesenfeld says.

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Cancer screening guidelines for women questioned

Washington, D.C.

Recent changes in women's cancer screening advice stunned some local health care providers.

Last week, a recommendation issued by the U.S. Preventive Services Task Force said women should generally begin getting routine mammographies at age 50, instead of 40.

The American College of Obstetricians and Gynecologists also recommended limiting cervical cancer screenings to women ages 21 and older, regardless of their sexual history.

Local medical officials question the logic that these new recommendations will prevent unnecessary anxiety and false alarms among younger women.

Wayne Young, director of Battle Creek Health System's The Cancer Care Center, said women in their 40s who are given mammographies are more likely to detect breast cancer at an early stage when it is more treatable.

A mammography is not 100 percent accurate, but it is the best early detection tool physicians have, he said. Abnormal results can be followed with needle biopsies and further tests for cancer.

"It's a little discomfort for some women; for others it will save their lives," he said.

Young said his mother and sister died of breast cancer before age 50. His three daughters will be screened early because of their genetic link, but he wanted all young women to get the best preventive treatment available to them as soon as possible.

His biggest concern is that health insurers will follow these agencies' recommendations and retract coverage for screening younger women, he said.

"That will become an issue because, especially in this economy, that will be an extra out-of-pocket cost and some people will put it off until age 50," he said.

Dr. Kari Formsma, a Battle Creek gynecologist and obstetrician with Pathway Women's Health, said she is concerned about the recommendation to limit cervical cancer screenings regardless of women's sexual history.

She said the guideline fails to acknowledge child sexual abuse and teenage promiscuity.

Cervical cancer is caused by certain strains of the human papillomavirus. It is a sexually transmitted infection that a condom cannot protect against. A woman's risk of developing cervical cancer increases with the number of sexual partners she has.

o it doesn't make sense to say a 21-year-old virgin is at more risk of getting cervical cancer than a 12-year-old victim of sexual abuse who has had multiple partners before age 21, she said.

The American College of Obstetricians and Gynecologists issued the recommendation because cervical cancer takes an average of five years to develop. But that assumes women don't begin having sex until they are 16, Formsma said.

She agreed with the task force's recommendation against teaching breast self-examinations on the grounds that it is often more harmful than not. Women who perform self-exams are more likely to find and be treated for benign lumps, according to the research.

"Breast self-exams, I tell patients to do them if they feel like it," she said. "I'd rather them do things that are a clearly proven benefit, like exercising every day."

She also applauded the move away from annual cervical cancer exams to every two years for women with normal Pap tests.

The money spent on unnecessary exams would do more good testing sexually active teens for infections, she said.

Overall, Formsma recommended patients disclose their full sexual history with their doctor to know how high a risk they have of developing cervical cancer, and then schedule screenings on an individual basis.

Young said the same is true for women in their 40s who are concerned about breast cancer. Women who have a family history of breast cancer or a genetic predisposition should consult their doctor about getting earlier screenings.

"A woman just needs to check with her primary care physician because those people ... can recommend whether she should get a mammogram or not," he said.

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New cervical cancer screening guidelines: No more 'annual' Pap Smear Tests

Washington, D.C.

Doctors Say Young Women Can Wait for First Pap, and Get Them Less Often

Pap smears may no longer be called "annuals" if doctors follow new cervical cancer screening recommendations from the American College of Obstetricians and Gynecologists.

The group announced today that women should start getting cervical cancer screenings at age 21 instead of 18, and that women could wait longer between the screenings -- regardless of when a woman starts having sex.

Women in their 20s with normal Pap smear results now should get screenings every two years instead of every year, and women in their 30s can wait three years between screenings, according to the new ACOG guidelines.

After a week of uproar over the controversial recommendations for less mammogram screenings for women, doctors say they will have to wait and see how the public reacts to the new pap smear guidelines.

"This is not a radical change in screening practices. This is something that's been coming gradually since the 1980s," said Dr. Alan G. Waxman, who helped write the new guidelines.

Some doctors hailed the decision as a way to reduce a host of problems caused by excessive screening; yet, a few others worried it might trigger more women to neglect annual checkups with gynecologists.

Waxman said the move toward fewer screenings will reduce unnecessary treatment in young women and protect them from future pregnancy complications.

On one hand, college-aged women have very high HPV infection rates. Dr. John Curtin, of The Cancer Institute at NYU Langone Medical Center in New York City said 70 percent of all college-aged sexually active people have contracted HPV. These high infection rates translate into a high number of abnormal pap smears.

However, the ACOG guidelines point out that only 0.1 percent of cervical cancer occurs in women under 21 years of age in part, doctors believe, because young women's immune systems are strong enough to fight off HPV before it causes cancer. When dysplasias progress to cancers it's usually a result of older women missing screenings for years at a time; 50 percent of women diagnosed with cervical cancer each year never had a pap smear before, according to the ACOG statement.

And some research has suggested the diagnostic surgery that often follow an abnormal result can pose problems for future pregnancies in some women.

"The driving force behind the change was the numerous studies that show women who are treated for cervical dysplasias are more likely to have a preterm birth," said Waxman, who is a professor at the University of New Mexico in Albuquerque.

Unnecessary HPV Treatment Can Lead to Pregnancy Problems

Waxman explained that the LEEP procedure to remove precancerous tissue often caused by an infection with the human papillomavirus, or HPV, also weakens the cervix. In fact, it's estimated, one in 18 women who've had a LEEP procedure will go on to give birth prematurely.

But, he added, new studies have shown "with most of the cervical abnormalities in adolescents, most of them get better by themselves. ... The thought is that these are the people who have most of their child-bearing years in front of them."

The ACOG recommendations cite studies showing that up to 90 percent of these infections are cleared on their own in adolescents within a few years.

The measure also was intended to reduce anxiety in young women who may struggle with the news that they are infected with a sexually transmitted virus known to cause cancer.

"I was convinced I was dying, that I had cancer. There was not enough education back then," said Nicole C., a resident of La Porte, Texas, who was diagnosed at age 22 with cervical dysplasia -- an abnormal Pap smear -- caused by HPV. "My doctor at the time made me feel horrible about myself, accusing me of not being truthful about how many partners I'd had."

Reducing Anxiety Now and Later On

Nicole, who asked that her last name not be used for privacy reasons, had her first abnormal Pap smear in 1998. As the years passed, more of her friends were diagnosed with cervical dysplasia in their 20s.

As Nicole started serving as an impromptu counselor to explain how HPV is spread, she aimed to soothe fears and reduce the stigma.

"If I had known more back then, I would not have freaked out about it," she said. "I wished they had done that [changed the guidelines] years ago."

Many doctors say they recognize the same anxiety on their young patients' faces.

"Yes, the diagnosis of an abnormal Pap can cause emotional distress to an adolescent girl, and I have certainly seen that," said Dr. Elizabeth Alderman of Montefiore Medical Center in the Bronx, N.Y. "[Cervical biopsies] and repeat Pap smears with visits cost a lot of money."

In fact, some doctors felt the new recommendations did not go far enough.

Dr. Diane Harper of the University of Missouri-Kansas, who specializes in HPV infections, felt that ACOG is behind the other recommending bodies in the United States that argue screening should start at age 25, not age 21.

"There is ample evidence that screening earlier than 25 years is only costly with many false positives," said Harper. "The rest of the world is going to an every-five-or-six-year screening interval ... and ACOG is now just endorsing the three-year interval for HPV negative and Pap negative [women]."

Doctors speaking to ABCNews.com also said they felt the best way to prevent more cancer deaths wasn't to re-screen women who are already seeing doctors regularly, but to try to get women who aren't getting screenings at all into the doctors.

"Whether we screen everybody every two or three years isn't probably not going to make a big difference I don't think, just as long as they are getting screened," said Curtin. "The fact remains there are unscreened patients and they are at risk for cancer."

Doctors speaking to ABCNews.com also said they felt the best way to prevent more cancer deaths wasn't to re-screen women who are already seeing doctors regularly, but to try to get women who aren't getting screenings at all into the doctors.

"Whether we screen everybody every two or three years is probably not going to make a big difference, just as long as they are getting screened," said Curtin. "The fact remains there are unscreened patients and they are at risk for cancer."

Negative Effects of Fewer Pap Smears Unknown

On the other hand, many women admit that the only reason they go to a doctor is for an annual Pap smear and contraception. For those reasons, some doctors worry such women won't receive any medical checkups at all.

"Honestly, the first time it was discovered, I was going to Planned Parenthood for contraception because I had just become sexually active. It was only my second partner," said Alicia, a 32-year-old woman from New Orleans who also did not want her last name used.

Alicia had her first abnormal Pap smear when she was 18.

"I cried, and I really, really freaked out," she said.

But the task of treating her abnormal Pap smears made her aware of her health.

"That was a pivotal moment in my life," she said. "I started doing things better. I started getting into gardening and doing things to calm down."

Dr. Donnica Moore, president of Sapphire Women's Health Group and an obstetrician-gynecologist by training, worried that the new guidelines might keep women who've had a normal Pap smear, or no symptoms, away from the doctor.

"Women may now assume -- incorrectly -- that if they only need a Pap smear every two or three years, then they only need to see their gynecologist every two to three years, and for many of these women, their gynecologist is their primary care physician," said Moore. "Thus, they will not be getting a routine physical, breast exam, blood pressure measurement, and sexually-transmitted infection testing."

Changing Recommendations on Pap Smears
However, Friday's changes aren't the first to affect cervical cancer screenings. Over the years, doctors have scaled back on cervical cancer screening schedules after more research proved less frequent screenings were effective.

"It is about time this occurred," said Dr. Mark Einstein of the Montefiore Medical Center in the Bronx, N.Y. "Oftentimes, young women are put into a 'high-risk' category, clinically, because they have a [positive] Pap test that is essentially just a sign of an HPV infection -- but it is not clinically relevant. This leads to anxiety and over-testing."

Dr. Joanna Cain of Brown University agreed, and argued that the HPV vaccine will further decrease the transmission of the virus that is responsible for up to 70 percent of cancers in the coming years.

Below is a timeline of changes to cervical cancer screenings over the years, according to Waxman:

1957 -- The American Cancer Society runs a nationwide campaign for women to get a Pap test every year.

1976 -- Canadian health leaders examine data and recommend a woman get a Pap smear every two years, after a woman has three consecutive normal Pap smears.

1980 -- The American Cancer Society follows Canadian guidelines recommending a woman get a Pap smear every two years after three consecutive normal Pap smears.

1988 -- The American College of Obstetricians and Gynecologists recommends starting screening at 18, or with the onset of sexual activity and getting a Pap test every year. But after three negative Pap tests, women should be screened less often.

2003 -- ACOG guidelines shift from recommending the first Pap smear at age 18 or the onset of intercourse to age 21 or three years after the onset of intercourse.

2008 -- The American College of Obstetricians and Gynecologists guidelines shift to recommend adolescents who have a minor abnormality on a Pap test wait to get biopsies and a diagnostic test called a colposcopy.

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Pap Smear Test guidelines changed: Fewer Pap Tests advised for women in 20's

Washington, D.C.

Most women in their 20s can have a Pap smear every two years instead of annually, say new guidelines that conclude that's enough to detect slow-growing cervical cancer.

The change by the American College of Obstetricians and Gynecologists comes amid a separate debate over when regular mammograms to detect breast cancer should begin. The timing of the Pap guidelines is coincidence, said ACOG, which began reviewing its recommendations in late 2007 and published the update today in the journal Obstetrics & Gynecology.

The guidelines also say:

— Routine Paps should start at age 21. Previously, ACOG had urged a first Pap either within three years of first sexual intercourse or at age 21.

— Women 30 and older should wait three years between Paps once they have had three consecutive clear tests. Other national guidelines have long recommended the three-year interval; ACOG had previously backed a two- to three-year wait.

— Women with HIV, other immune-weakening conditions or previous cervical abnormalities may need more frequent screening.

Paps can spot precancerous changes in the cervix in time to prevent invasive cancer, and widespread use has halved cervical cancer rates in the U.S. in recent decades. About 11,270 new cases will be diagnosed this year, and about 4,070 women will die from it, according to American Cancer Society estimates. Half of women diagnosed with cervical cancer have never had a Pap, and another 10 percent haven't had one in five years.

Cervical cancer is caused by certain strains of the extremely common sexually transmitted virus called HPV, for human papillomavirus. There is a new HPV vaccine that should cut cervical cancer in the future; ACOG's guidelines say for now vaccinated women should follow the same Pap guidelines as the unvaccinated.

But the updated guidelines reflect better understanding of HPV. Infection is high among sexually active teens and young adults. Women's bodies very often fight off an HPV infection on their own without lasting harm, although it can take a year or two. The younger the woman, the more likely that HPV is going to be transient.

Moreover, ACOG cited studies showing no increased risk of cancer developing in women in their 20s if they extended Pap screening from every year to every two years.

As for adolescents, ACOG said cervical cancer in teens is rare — one or two cases per million 15- to 19-year-olds — while HPV-caused cervical abnormalities usually go away on their own, and unnecessary treatment increases the girls' risk of premature labor years later.

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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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Clash of the Titans for the HPV Vaccine Market

New York City, NY

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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New cervical cancer test beats pap smear test

London, UK

A new way to test for cervical cancer is more accurate than a pap smear and identified more dangerous lesions, an Italian study showed on Tuesday.

Researchers used the traditional test for the human papilloma virus that causes cervical cancer and combined it with another that indicated specific cancer-causing activity in cells, said Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, who led the study.

A simple test for a protein called P16INK4A provided a biomarker showing cell changes that indicated a woman likely has pre-cancerous lesions, Ronco and colleagues reported in the journal Lancet Oncology.

"The marker shows there was some sort of disruption by the HPV virus," Ronco said. "Only a small minority of women who have an HPV infection actually develop cancer. The challenge is to find out who are at higher risk of developing cancer."

Cervical cancer is the second most common type of cancer in women. Each year an estimated 500,000 women are diagnosed with the disease and about 300,000 die from it, mostly in the developing world.

Merck & Co's Gardasil and GlaxoSmithKline's Cervarix are vaccines that protect against some strains of the virus.

More countries are also adopting screening tests, but the problem is pap smears produce too many false positives -- meaning women get a test that suggests they have potentially cancerous or pre-cancerous changes when in fact they do not.

An HPV test looks for the virus while in a pap smear doctors scrape cells from the cervix and examine them under a microscope for abnormalities that could indicate precancerous lesions.

"Most HPV infections simply regress without causing disease," Ronco said in a telephone interview. "They disappear spontaneously, which is the reason there are so many false positives."

The Italian team collected cervical cell samples from women who had already tested positive for the HPV virus, most of whom had already undergone an expensive colposcopy exam -- a close examination of the cervix using a magnifying instrument.

Then they tested for P16INK4A protein in more than 1,100 of these women and found that it helped identified 88 percent of those who had the cancer-causing lesions with far fewer false positives. The protein is more active in cervical-cancer cells.

The refined test also identified 50 percent more of the dangerous lesions than pap smears and required fewer women to be referred for colposcopy, Ronco said.

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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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FDA says Cervarix vaccine blocks cancer-causing HPV virus

Washington, D.C.

A vaccine from GlaxoSmithKline successfully blocks the virus that causes most cases of cervical cancer, the Food and Drug Administration said Friday.

In documents posted online, the FDA said Cervarix — Glaxo's vaccine against human papilloma virus or HPV — successfully blocked the two most cancerous strains of the virus nearly 93 percent of the time.

The main study of the vaccine enrolled more than 18,000 women who either received Cervarix or a sham treatment. The FDA said the vaccine appears to fight the HPV virus for more than six years, based on company data. Side effects were minor, such as pain and swelling at the injection site.

The agency will ask a panel of vaccine experts next week whether Cervarix should be approved for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does.

A positive review from the agency will clear the British drugmaker's vaccine to compete in the U.S., though it could face an uphill battle against Merck's blockbuster vaccine Gardasil, which has been on the market here since 2006.

Besides having a three-year head start, Gardasil also defends against two more HPV types that cause 90 percent of genital warts, something Cervarix does not target.

Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007 when the FDA said it needed additional data.

Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with the alternate treatment.

The FDA said Friday it asked outside experts to examine more recent data from the company to see if Cervarix could have caused those problems.

"The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review.

The FDA said it would ask Glaxo to report any continuing problems in a follow-up study planned for after the vaccine's launch.

About 6 million people in the U.S. each year contract HPV, which usually causes no symptoms and clears up by itself. While there are about 40 strains of the virus that are spread through sexual contact, only about 15 cause cancer in men and women.

Last year nearly 4,000 women died of cervical cancer.

"Protection against cervical cancer is a very important health need for girls and young women, and we believe Cervarix has an important role to play in addressing this," said Glaxo spokeswoman Lisa Behrens.

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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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Washington University PET scanner tracks cervical cancer

St. Louis, MO

A machine invented at Washington University to reveal the inner workings of brains and hearts is emerging as a premier tool for tracking cervical cancer.

The device, called a positron emission tomography (PET) scanner, is similar to MRI scanners but uses radioactivity instead of X-rays to create images of blood flowing through organs, brain activity and other processes.

New research from the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University show that PET scans are more accurate than any other method at predicting the aggressiveness of a cervical cancer tumor. The device also effectively shows whether treatments had destroyed the cancer.

Previously, doctors had no way to determine whether radiation or other therapies were working until a patient experienced symptoms or another tumor was found.

"The look on (patients') faces, the happiness and the joy when you tell them, "It looks like you're going to do really well.' That's really powerful," said Dr. Julie K. Schwarz, a Barnes-Jewish Hospital resident in the Department of Radiation Oncology.

Schwarz was the lead author on one of the PET studies that was published last month in the Journal of the American Medical Association. Her research team studied women who had PET scans three months after completing radiation and chemotherapy between 2003 and 2006. The scans provided a more reliable measure of whether the cancer would recur, and, just as importantly, revealed whether the cancer was already beginning to return.

Each year, more than 10,000 women develop cervical cancer in the United States; about 3,900 die of the disease.

A key to turning PET scans into cancer-fighting tools was figuring out how to turn one property of cancer cells - their need for sugar to fuel growth - against them.

Now, researchers are trying to find out if the scans can do more than identify cancer cells quickly.

PET scans aren't used yet for every cancer patient, but they are proving to be effective at helping doctors decide whether to continue treatment. The scans already are used to detect spreading and recurrence of breast, ovarian, brain and other types of cancers.

"It has a big impact on preventing radical therapy that has no hope of curing the patient," said Dr. Barry Siegel, director of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University.

In some studies, researchers treated cancer patients with chemotherapy drugs, and within days, they were able to use PET scans to see whether the drug is working or a different type of treatment was needed.

The technology is complicated and expensive and requires highly specialized technicians to make the radioactive chemicals and administer the tests and well-trained doctors to interpret the results, said Dr. Elizabeth Swisher, a gynecological oncologist and associate professor at the University of Washington in Seattle. And, she added, the scans are not standardized.

"It's not the same to get a PET scan everywhere," Swisher said. "Just because it's an expensive test doesn't mean it's a good test."


Washington University is a leader in PET technology, Swisher said, adding that studies such as the one on Monroe will likely expand the use of PET in cancer treatment.

Monroe, who lives in south St. Louis County, had put off going to the doctor, even though she suspected that something was wrong. But after she was diagnosed with cervical cancer, she didn't put off treatment. She never missed a day.

The PET scan she had toward the end of her treatment showed that her tumor has shrunk significantly, Schwarz said. It's likely that the tumor will continue to shrink and disappear - a very promising prognosis. A follow-up PET scan three months after she completes chemotherapy will tell for sure.

"They told me (my PET scan) all looks good," Monroe said. "That's good enough for me. I'm happy with that."

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