Friday, April 25th, 2014
An alternative method to the traditional Pap smear test has received approval from the federal government as an acceptable screening test to detect cervical cancer. The approval comes amid objections from some women’s health organizations, as The New York Times reports:
The new test, developed by Roche, detects the DNA of the human papilloma virus, which causes almost all cases of cervical cancer, in a sample taken from the cervix. Pap testing involves examining the cervical sample under a microscope to detect abnormalities.
A committee of outside advisers to the F.D.A. unanimously endorsed the Roche test in a meeting last month.
But a coalition of 17 consumer, women’s and health groups opposed the approval, arguing that the new screening method had not been adequately tested and could upend a practice that has successfully prevented cervical cancer for decades.
“This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives,” the coalition said in a letter to the F.D.A. earlier this month.
The letter was organized by the Cancer Prevention and Treatment Fund, a research and patient education organization, and signed by the American Public Health Association, Consumers Union, the National Organization for Women and the women’s health education group Our Bodies Ourselves, among others.
A separate letter making similar arguments was sent to the agency earlier this week by a group of doctors and professors.
The F.D.A. said, however, that the evidence was sufficient.
“Roche Diagnostics conducted a well-designed study that provided the F.D.A. with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer,” Alberto Gutierrez, the agency official who oversees diagnostic testing, said in a statement.
Image: Pap smear test, via Shutterstock
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Monday, March 17th, 2014
The Pap smear test, which women have had annually for decades as a way of screening for cervical cancer, may soon become passe, as a Food and Drug Administration panel has recommended a different test, also performed by vaginal swab, as the first line of defense against the disease. The new test looks for the DNA of the human papillomavirus, or HPV, which is the cause of more than 99% of all cervical cancers, while Pap tests look for abnormal squamous cells that could indicate cervical cancer. More from CNN.com:
Up until now, the Pap was the first test women had to detect the illness, with the HPV test as a second analysis. But if the FDA follows the advisory committee’s recommendations, that would change.
The committee, which voted unanimously to make the switch, would only allow the Roche cobas test to be used alone as the primary evaluation for women 25 years and older. Although there are other HPV tests available, the Roche test detects two strains of the virus that are found in 70% of all cervical cancers.
“Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer,” said Dr. Thomas Wright Jr., an expert in gynecology and pathology at Columbia University Medical Center.
“I am pleased that the FDA panel recognized the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”
This does not mean the Pap test will go away. It will really be up to the physician and the patient on how best to handle testing. But according to women’s health experts, in most cases, patients who don’t have HPV are less likely to need a Pap, which is why the advisory committee felt it best to recommend the Roche test be administered as the first form of detection.
“I think anytime guidelines are changed, it becomes confusing for both patients and physicians. And we’re going to have to do more research on what’s best,” said Dr. Angela Marshall, director of Comprehensive Women’s Health of Maryland. “But the fact that the FDA is looking to make these changes says we’ve made great strides in detecting and treating cervical cancer.”
Image: Speculum, via Shutterstock
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Tuesday, February 11th, 2014
Only about a third of American girls–and less than 7 percent of boys–received the vaccine against human papillomavirus, or HPV, in 2012, a number that is too low for what public health officials had hoped would take hold when the vaccine was first introduced. This is the finding of a report from the President’s Cancer Panel, which urged action to improve vaccination rates in order to prevent cervical, vaginal, anal, and some oral cancers.
Among other recommendations, the panel suggests that pharmacists be allowed to administer the vaccines, and that pediatricians be proactive in recommending the vaccine to patients.
The panel’s report has slightly different data from earlier findings, such as one report from the CDC that 1 in 5 boys are receiving the vaccine, and another CDC report, released in 2013, that said half of girls receive the vaccine.
The vaccine was first recommended for girls ages 11 and 12 beginning in 2006, and then recommended for boys in 2011.
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Image: Child getting a vaccine, via Shutterstock
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Tuesday, November 5th, 2013
A single dose of the vaccine against human papillomavirus, a leading cause of cervical cancer, may be enough to immunize a woman against the disease, a new study has found. Three doses are the current guideline, though research shows that fewer than half of American girls receive the recommended number of doses. More from CNN.com:
“Cervical cancer is a major cause of public health concern, especially in less developed countries where about 85% of cervical cancer occurs,” says study author Mahboobeh Safaeian. “The reason for that is mainly because of lack of screening infrastructure offered.”
Safaeian and her team followed a group of women in Costa Rica who were participating in the National Cancer Institute-funded phase III clinical trial testing the efficacy of Cervarix. About 20% of these women did not complete the three-dose vaccine regimen. Safaeian compared the groups of women who had received one, two and three doses of the vaccine, as well as women who had antibodies from having been naturally infected.
The researchers found that women vaccinated with a single dose of Cervarix, as opposed to the current CDC recommendation of three, had antibodies against HPV that remained stable in their blood after four years. The findings suggest that the common recommendation for three doses may not be necessary to ensure long-lasting antibodies that prevent HPV. Safaeian, a researcher for the National Cancer Institute’s Division of Cancer Epidemiology & Genetics, Infections and Immunoepidemiology, says this could have significant implications for women across the world by simplifying the logistics and costs of vaccinations.
“This vaccine is about $130 a dose … It’s just not feasible in a lot of undeveloped countries,” Safaeian explains.
Image: Girl getting a vaccine, via Shutterstock
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Monday, September 2nd, 2013
A new government report reveals that a surprising number of boys received the vaccine for human papillomavirus (HPV) last year, the first year that it was recommended for adolescent boys. The Centers for Disease Control and Prevention says 1 in 5 boys received at least one dose of the HPV vaccine, NBC News reports.
Shared through sexual contact, HPV can cause cervical cancer in women and genital warts in both sexes, and in rare cases, throat and anal cancer. The vaccine was first recommended for girls ages 11 and 12 beginning in 2006, and then recommended for boys in 2011. More from NBC News:
The shots are largely intended not to protect boys from disease, but to stop them from spreading a sexually transmitted virus to girls that could cause cervical cancer.
The vaccine hasn’t been very popular among girls. The government report issued Thursday is the first real sense of how many boys are getting the shots.
“It’s a good start,” said Shannon Stokley, a vaccination expert with the Centers for Disease Control and Prevention.
Introduced in 2006, the vaccine protects against human papillomavirus, which is spread during sex. Most infections go away on their own, without people developing symptoms. But the virus can cause cervical cancer in females, genital warts in both sexes, and some other, less common conditions like throat and anal cancer.
The vaccine was first recommended for girls ages 11 and 12 because it works best if given before a teen starts to have sex. In 2011, it was also recommended for boys that age to help prevent the virus’s spread.
The CDC report covers vaccination rates for last year, the first full year since the shots were advised for boys. It’s based on telephone calls to families for about 19,000 boys and girls ages 13 to 17.
About 21 percent of the boys had gotten at least one of the three doses. Less than 7 percent were fully vaccinated.
The rates look relatively good compared to the initial rates for some other vaccines aimed at adolescents. For example, the initial rate for a meningococcal vaccine was just 12 percent.
Rates tend to start low when a vaccine is first recommended and build after. So the HPV numbers for boys are reason to be optimistic, said the CDC’s Dr. Melinda Wharton, although she added a word of caution.
“Given how the coverage level has stalled for girls, though, a solid start isn’t enough,” she said.
Image: Three teen boys, via Shutterstock
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