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Robotically Assisted Hysterectomy vs. Laparascopic
Robotically assisted hysterectomies dramatically increased from 2007 to 2010, but with little benefit, according to a review of data from 400 hospitals recently published in
JAMA. Read the report
Incidence of Advanced Breast Cancer May Be Increasing in Young US Women
More young women in the United States apparently are being diagnosed with advanced breast cancer than in the past, a trend not seen among older women, according to a study appearing in JAMA.
Although the numbers remain small, the finding is a concern, because breast cancer in young women tends to be more aggressive disease and is associated with lower survival rates than breast cancer in older women. In 1976, the rate of diagnosis of advanced breast cancer (cancer that has metastasized to parts of the body away from the breast such as the brain, lungs, or bones) among women aged 25 to 39 years was 1.53 cases per 100 000 women; by 2009, the rate had climbed to 2.90 cases per 100 000, an annual increase of 2.07%. The study is based on data from 3 US National Cancer Institute Surveillance, Epidemiology, and End Results databases spanning 1973-2009, 1992-2009, and 2000-2009.
Lead author Rebecca H. Johnson, MD, of Seattle Children’s Hospital and the University of Washington, discusses her team’s findings:
Why did you want to see if the incidence of breast cancer in young women was increasing?
I’d had that question in mind for years. I was diagnosed with breast cancer when I was 27. And after that, I’d meet young women patients with breast cancer and it seemed like a lot of friends of friends had breast cancer. And yet the literature kept saying that breast cancer in young women was rare.
And you found the incidence of advanced breast cancer in young women has increased.
We found that after analyzing women of all ages and breast cancer stage at diagnosis, there was a significant increase of metastatic breast cancer in young women and only young women. The increase was most prominent in the youngest cohort, those aged 25 to 34, and decreased in each age cohort, such that there was no significant increase in women over age 54. And we found the rate of increase increased over time.
Any thoughts as to why advanced breast cancer has increased in younger women?
What we studied doesn’t address causality, so the next steps for researchers will be to examine potential causes for this trend and look at etiologies. Given there’s such a change over a short amount of time, we may find modifiable risk factors or potentially toxic exposures that are fueling this increase.
Did you find a similar increase in death rates from breast cancer in young women?
The death rate in this age cohort, young women with metastatic breast cancer, has remained fairly stable in the 34-year interval we studied, suggesting better medical strategies and supportive care strategies.
Do your findings make a case of general population mammography screening for women under age 50 years?
What the average young woman should not do is go get a mammogram, because while on a population level we saw a statistically significant increase, it’s not a large increase of risk for an individual. One thing that has the potential to affect young women’s survival is earlier detection—seeing a physician if you find a lump instead of ignoring it.
Age Restriction Removed on OTC Morning-After Pill
A federal judge has reversed an HHS decision that restricted over-the-counter access to the levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step to women and girls 17 and older. In his ruling, Judge Edward Korman of the U.S. District Court's Eastern District of N.Y. cited political pressure as a reason for the 2011 decision by Department of Health and Human Services secretary Kathleen Sebelius that prevented the FDA from expanding over-the-counter access to the pills without age restrictions, as the agency had planned.
"Secretary Sebelius's directive to the FDA ... forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability," Korman wrote in his opinion yesterday.He ordered the FDA to "make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days." Nancy Northup, president and CEO of the Center for Reproductive Rights, one of the plaintiffs in the court case, said the ruling "has swept away all the FDA's stalling, all the interfering, and all the political gamesmanship." The message is clear, she said on a conference call with reporters: "Women's reproductive health and access to reproductive healthcare must never be held hostage by politics."
Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006. That decision followed a denial of a Citizen Petition from reproductive-rights groups seeking over-the-counter access for all age groups. In 2009, Korman ruled that the FDA must make the pill available without a prescription for 17-year-olds as well, concluding that the FDA's denial of the Citizen Petition was "arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making."Korman agreed that "the FDA bowed to political pressure emanating from the White House and departed from agency policy." He did not remove all age restrictions at that time, deciding instead to leave the decision to the FDA, which had come under new leadership after President Barack Obama was elected.
The single-pill version of the drug -- Plan B One-Step -- was approved later that year and was subject to the same age restrictions.The manufacturer -- Teva Women's Health -- then submitted a supplemental new drug application seeking to allow over-the-counter access to girls and women of all ages.The FDA initially approved the application, and commissioner Margaret Hamburg, MD, explained that the agency "determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases." Sebelius disagreed with the decision, however, and ordered the FDA to deny that application, stating "that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages." President Obama supported the decision. Korman reversed that decision yesterday, but left open the possibility of further action from the FDA. "On remand, the FDA may determine whether any new labeling is reasonably necessary," he wrote. "Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product."
Model May Predict Final Menstrual Period
A new model using levels of two hormones may help predict when perimenopausal women will have their final period, researchers reported. Using data from a cohort study, a model that takes into account levels of follicle-stimulating hormone (FSH) and estradiol predicted the likelihood of perimenopausal women being 2 years away from their final period with an 85% sensitivity and a 77% specificity, Gail Greendale, MD, of the University of California Los Angeles, and colleagues reported online in the
Journal of Clinical Endocrinology & Metabolism
"If further research bears out our approach, it could be the first step to developing web-based calculators and other tools women can use to estimate where they are in the menopause transition and how far away their final period is," Greendale said in a statement. Researchers have long been trying to find a way to predict when a woman's final menstrual period will occur, since it can help determine the risk of other biological changes, including accelerated bone loss, which tends to happen in the final year of menstruation. Some researchers have suggested that starting an intervention 1 or 2 years before the final menstrual period could lower future fracture risk, Greendale explained. To try to predict a final period, the researchers looked at a sample of 554 women from the Study of Women's Health Across the Nation (SWAN) who had undergone measurement of their levels of FSH and estradiol, and used these factors to model the probability of the women having crossed specific landmarks: 2 years prior to their final period, 1 year prior, and the final menstrual period. The final models included not only the two hormones, but also age, menopause transition stage, and race/ethnicity. Overall, they found high numbers for the area under the curve (AUC) for prediction of all three events:
2 years prior to the final period (AUC 0.902)
1 year prior to the final period (AUC 0.926)
The final menstrual period (AUC 0.945)
Sensitivity and specificity for predicting a landmark at 2 years prior to the final period were 85% and 77%, respectively. "We demonstrated that classification of a woman as having crossed a landmark [related to the final menstrual period] can be done with high sensitivity and specificity," they wrote. "The model's discrimination -- its ability to correctly rank women according to whether or not they had crossed a landmark -- was excellent." The study was limited because it only sampled the two hormones annually, and more frequent sampling could be implemented in clinical practice, potentially leading to more accurate outcomes, the researchers noted. They also called for replication of their model in an independent sample before it can be used clinically, adding that once it was validated, "user-friendly web-based calculators could be developed."
The Reason Pregnant Women Are More Vulnerable To Certain Infections Is Likely Due To Progesterone
Women who are pregnant or using synthetic progesterone birth control injections have a conspicuous vulnerability to certain infections including malaria, Listeria, HIV, and herpes simplex virus. A new research report appearing in the March 2013 issue of the Journal of Leukocyte Biology offers strong evidence for a possible explanation: the progesterone receptor, a pregnancy hormone sensor, targets a part of the immune system responsible for protection against these and other invaders. In addition to helping explain why some women are more vulnerable to certain infections, it also sheds light on why some autoimmune diseases, notably rheumatoid arthritis and multiple sclerosis, often go into remission during pregnancy.
"We hope that continued work in this area will ultimately yield better approaches to the prevention of immunological complications of pregnancy, safer and more effective forms of hormonal birth control and novel biological targets for the treatment of autoimmune diseases," said Grant C. Hughes, M.D., a researcher involved in the work from the Division of Rheumatology and Department of Immunology at the University of Washington in Seattle, WA.
To make their discovery, scientists used two groups of mice. The first group had a mutated progesterone receptor, or PR gene, which rendered the mice's bodies incapable of sensing progesterone through PR (PR knockout mice). The second group was comprised of normal mice. After various forms of immunization, antibody responses were tracked. When compared to normal mice, PR knockout mice produced much higher antibody levels, but only in response to forms of immunization requiring T cells, a cell type that normally boosts antibody production by B cells. This prompted a closer look at B and T cells from the PR knockout mice. The researcher saw that when stimulated in the test tube, knockout B cells showed normal, if not slightly less, antibody production compared to controls. On the other hand, knockout T cells stimulated in the test tube showed a conspicuous over-production of interferon-gamma, an inflammatory molecule involved in fighting off pregnancy-associated pathogens and in shaping protective antibody responses. Adding progesterone to the test tube blocked interferon-gamma in normal T cells, but not in PR knockout T cells. This suggests that progesterone suppresses interferon gamma in T cells through their PR. To sort out which aspects of the abnormal antibody responses in PR knockout mice were due to T cells, researchers immunized two groups of normal mice, one transplanted with responder T cells from PR knockout donors, the other with responder T cells from normal donors. Just like in PR knockout mice, normal mice transplanted with PR knockout responder T cells showed much higher antibody levels than normal mice.
"Pregnancy and hormones have long been known to influence immune responses, but these processes have been poorly understood, said John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology. "This new work is significant for two reasons. First, the identification of progesterone receptors as a mechanism of immune modulation during pregnancy sheds light on the pregnancy-immune phenomenon, and second, these studies define a potentially new target to modulate autoimmunity and immune-mediated problems during pregnancy."
CDC: Give Tdap During Every Pregnancy
Women should receive the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during every pregnancy -- regardless of vaccination history -- to help protect both themselves and their offspring, final CDC recommendations stated. The idea is to enhance protection against pertussis, which has become more of a problem in recent years. The provisional numbers for 2012 -- 41,880 pertussis cases and 14 deaths in infants younger than 1 year -- have surpassed those from the last peak year of 2010.
The new recommendation, initially adopted by the Advisory Committee on Immunization Practices (ACIP) in October, became final after acceptance by the CDC director and publication in the Feb. 22 issue of Morbidity and Mortality Weekly Report. In 2008, ACIP recommended that Tdap should be given shortly after women gave birth to provide a measure of protection against pertussis for newborns, who do not begin the childhood DTaP series until they are 2 months old and are thus unprotected. The rest of that five-dose series is administered at 4, 6, and 15 to 18 months, with the final dose given before the child enters school around age 4 to 6 years.In 2011, the committee voted to recommend giving a single Tdap dose to pregnant women toward the end of pregnancy (after 20 weeks of gestation), as opposed to immediately after delivery. That decision was based on evidence that maternal anti-pertussis antibodies pass through the placenta to the developing fetus, as well as an analysis showing greater reductions in infant pertussis, hospitalizations, and deaths when the vaccine was given during and not after pregnancy. The recommendation applied only to women who had not received Tdap previously.
To clarify what should happen in subsequent pregnancies, ACIP in October voted to recommend giving Tdap during each pregnancy, regardless of previous receipt of the vaccine. The vaccine can be given at any time during pregnancy, according to the guidance, but preferentially from 27 to 36 weeks of gestation."New data indicate that maternal anti-pertussis antibodies are short-lived," wrote Jennifer Liang, DVM, of the CDC's Division of Bacterial Diseases, and colleagues in MMWR. "Therefore, Tdap vaccination in one pregnancy will not provide high levels of antibodies to protect newborns during subsequent pregnancies. "When considering the recommendation, ACIP members concluded that the interval between pregnancies for most women likely would be greater than the amount of time maternal anti-pertussis antibodies persist.
Available data suggested that receiving more than one Tdap dose would be safe. And, because women have about two children on average, very few women would require four or more doses, according to the authors. "ACIP believes the potential benefit of preventing pertussis morbidity and mortality in infants outweighs the theoretical concerns of possible severe adverse events," they wrote.
The new guidance also provided information for vaccination in special situations:
If a woman requires a tetanus and diphtheria booster during pregnancy, Tdap should be given.
A tetanus toxoid-containing vaccine may be recommended for wound management in pregnant women if 5 or more years have elapsed since a previous tetanus and diphtheria toxoids (Td) booster. In that case, Tdap should be given.
Pregnant women with an unknown or incomplete tetanus vaccination history should receive three vaccinations containing tetanus and reduced diphtheria toxoids. The recommended schedule is 0, 4 weeks, and 6 through 12 months, but Tdap should replace one dose of Td, preferably from 27 to 36 weeks of gestation.
Liang and colleagues noted that the CDC will continue to monitor the effectiveness and safety of Tdap vaccination in pregnant women.
Repeat CT Scans May Up Breast Cancer Risk in Young Women
A female teenager who undergoes repeat chest or cardiac CT studies may see her 10-year risk for breast cancer double, researchers said here.After retrospectively reviewing the records of about 250,000 women enrolled in a large healthcare delivery system, researchers found that an increase in CT use between 2000 and 2010 may result in an increase in the risk of breast cancer for some women, including younger patients and those who undergo multiple radiation-based imaging studies.
"Until now, the impact of this increased use of imaging on radiation exposure to breast tissue and the subsequent risk of breast cancer has not been known," Smith-Bindman said in a written statement. "Our goal was to quantify imaging utilization and radiation exposure to the breast among women...and to use these data to determine the imaging-related risk of breast cancer from those studies."
The group collected CT dose parameters on 1,656 patients and used a newly developed, automated Monte Carlo computational method to estimate breast and effective doses.For nuclear medicine scans, data were abstracted on the volume of injected radiopharmaceutical for 5,507 exams and Monte Carlo methods were used to estimate breast doses.The breast-specific absorbed doses and the Preston 2002 pooled model for radiation-effects on breast cancer risk were used to estimate women's 10-year risk of developing breast cancer based on age at exposure to CT.Using NCI Breast Cancer Surveillance Consortium data, they estimated women's 10-year risk of breast cancer, based on the Gail model and Surveillance Epidemiology and End Results (SEER) age-specific cancer incidence data, and compared the imaging-related risk to the underlying Gail risk.They found increases in CT utilization from 2000 to 2010 of 99.8 CT scans per 1,000 women in 2000 to 192.4 CT scans per 1,000 women in 2010 for a 6.8% annual increase.Furthermore, in 2010, 46% of those CT studies exposed the breast to radiation.Radiation doses to the breast from CT scans were variable, but the highest breast doses were delivered by multiple-phase cardiac (median 51.6 mGy, IQR 21.2, 73.1) and chest CT (median 34 mGy, IQR 16, 74).
"A child or young adult who underwent two cardiac or chest CTs before the age of 23 has a higher 10-year risk of developing breast cancer from these exams than her underlying risk of developing breast cancer in the same period," the authors wrote.
Lead author Ginger Merry, MD, from Prentice Women's Hospital -- Northwestern Memorial Hospital in Chicago, emphasized that "the breast tissue is radiosensitive and CT of the chest, heart, and spine deliver significant doses. Younger women are at the highest risk due to increase radiosensitivity of the breast at younger ages, and longer life span to see cancer."While nuclear medicine imaging decreased from 39.3 scans per 1,000 women in 2000 to 27.5 scans per 1,000 women in 2010, for a 3.5% annual decline, 84% percent of nuclear medicine studies done in 2010 exposed the breast to radiation.Smith-Bindman also noted that the additive risk of radiation exposure might be even more problematic for women at high risk for breast cancer, with that risk increasing to 37 per 100,000 women from 32 per 100,000 women.
"Thus imaging should be used only when appropriate and when it will improve outcomes," she said. "Imaging providers need to assess the doses associated with each exam, limit multiphase protocols, and optimize the dose to minimize exposures and risk."
"The time period for this study is over 10 years, and CT technology over that period has changed substantially. The person in 2000 most likely did not get the same [radiation] dose as a person in 2010. Lumping together [time periods] like this creates a great deal of confusion," warned Morin, who is also a member of the RSNA Public Information Advisory Network.But he agreed that the important take-home message from the study is for radiologists to "image wisely. As long as the imaging study is ordered properly, the benefit to that patient will far outweigh any potential risk."
FDA OKs Device to Screen Dense Breasts
An ultrasound device for breast cancer screening - the somo-v ABUS - has been approved for use in women with dense breasts, the FDA announced. The product, made by U-Systems of Sunnyvale, CA, is to be used along with standard mammography in women with a negative mammogram and no breast cancer symptoms. U-Systems' product has a specially shaped transducer that automatically scans the entire breast in about 1 minute, producing several images for review, the FDA said. The company conducted a trial in which radiologists examined mammograms from 200 asymptomatic women with dense breasts, with and without supplementary ultrasound images from the somo-v ABUS device. Results indicated that use of the ultrasound images increased breast cancer detection by about 30%. About 4% of positive results in the trial were false. Women who have had a previous breast intervention such as surgery or biopsy would not generally be eligible for screening with the device, the agency said, "since this might alter the appearance of breast tissue in an ultrasound image." The latter restriction was recommended by an FDA advisory committee that voted unanimously in April in favor of the device's approval. The FDA will also require that U-Systems conduct training for clinicians and technologists who will use the device. It must also distribute a manual that describes quality control tests that users should perform regularly.
AMA Bucks USPSTF on Mammography
The American Medical Association's House of Delegates has come out in support of screening mammography for women starting at age 40. The new policy is in conflict with the controversial 2009 recommendation of the United States Preventive Services Task Force (USPSTF) that routine screening mammography for breast cancer was unnecessary in women younger than 50. The House of Delegates stopped short of recommending that "every woman should get routine screening mammograms every year starting at age 40." Strongly debated in Tuesday morning's session, that language was rejected by the delegates in favor of a lighter "should be eligible" phrasing. A number of medical groups, including the American Cancer Society, the American College of Radiology , and the American Congress of Obstetricians and Gynecologists disagreed with the USPSTF recommendations and said women younger than 50 benefit from having routine mammograms.
HRT Risk Holds Steady Based on Updated Review
Nearly a decade of additional research on hormone replacement therapy (HRT) for preventing chronic diseases still indicates more risk than benefit, a new evidence review suggested. Conducted to inform a new set of U.S. Preventive Services Task Force (USPSTF) recommendations on hormone therapy, the review by Heidi Nelson, MD, MPH, of Oregon Health and Science University in Portland, and colleagues, found that every current HRT regimen carries significant risks that, for most women, probably outweigh the benefit.
"Both hormone therapy regimens [estrogen unopposed or combined with progestin] decrease risk for fractures but increase risk for stroke, thromboembolic events, gallbladder disease, and urinary incontinence," they wrote online in Annals of Internal Medicine. They added that "estrogen plus progestin also increases risk for breast cancer and probable dementia, whereas estrogen alone decreases risk for breast cancer.
"In 2002, the USPSTF decided the risks of estrogen plus progestin outweighed likely benefits for preventing chronic conditions. The task force recommended against routine, long-term HRT use. It followed with a similar recommendation in 2005 for unopposed estrogen.Although the recommendations did not address short-term use to relieve menopause symptoms, many physicians and their patients took them to mean that HRT was too dangerous for any purpose.
Since the previous USPSTF recommendations were published, many more studies of hormone therapy have appeared. The group decided it was time for an update and commissioned Nelson and colleagues to review the recent research from 2002 to 2011. In particular, the researchers focused on randomized, placebo-controlled studies of menopausal HRT that evaluated primary prevention of conditions such as cardiovascular disease, cognitive decline, osteoporosis, and cancer.They ultimately identified nine trials, all of at least fair quality, that merited inclusion. Among them were:
Two main trials in the Women's Health Initiative (WHI)
Two spinoff WHI studies on memory and cognitive aging
Estrogen Memory Study (EMS)
Estrogen in the Prevention of Reinfarction Trial (ESPRIT)
Ultra-Low-Dose Transdermal Estrogen Assessment (ULTRA)
Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM)
Heart and Estrogen/Progestin Replacement Study (HERS)
The trials were too different in design and outcomes assessed to permit pooling of data. Instead, Nelson and colleagues wrote narrative summaries of what the studies found in answer to three key questions: what are the potential benefits of hormone replacement for preventing chronic conditions?, what are the harms?, and do benefits and harms differ by subgroups?
The researchers needed only three paragraphs to report the potential benefits, but they were clinically significant.In the WHI, invasive breast cancer incidence and mortality were reduced by 23% and 63%, respectively, with unopposed estrogen (both P<0.05). Diabetes was reduced by 21% and 35% (both P<0.05) in the WHI and HERS trials with estrogen plus progestin, but unopposed estrogen in the WHI study did not have such an effect.Hip, vertebral, and total fractures were reduced significantly with both hormone regimens in WHI but not in HERS. The WHI also held a possible signal for colorectal cancer prevention with estrogen plus progestin but it barely reached statistical significance (HR 0.75, 95% CI 0.57 to 1.00). That result was not confirmed in HERS, nor was it seen for unopposed estrogen in the WHI.Among the harms that were significantly increased with one or both hormone replacement regimens:
Invasive breast cancer (estrogen plus progestin)
Deep vein thrombosis (DVT, both)
Pulmonary embolism (estrogen plus progestin)
Breast cancer mortality (estrogen plus progestin)
Lung cancer mortality (estrogen plus progestin)
Gallbladder disease (both)
Probable dementia (estrogen plus progestin)
Urinary incontinence (both)
For both regimens, the number of women who would be expected to suffer harm per 10,000 person-years was far greater than those who would benefit from either regimen.With unopposed estrogen, there would eight fewer invasive breast cancers, 56 fewer fractures, and two fewer breast cancer deaths, but 11 more strokes, seven more DVT episodes, 33 more gallbladder disease cases, and 1,271 cases of urinary incontinence per 10,000 person-years.
The corresponding numbers for estrogen plus progestin were just as unfavorable.Nelson and colleagues were unable to answer their third key question, about special benefits or harms in subgroups. They had thought they might see different effects by age, type of hormone therapy, presence of comorbidities, or natural versus premature menopause.But despite the large numbers of women in the trials -- more than 27,000 in the two main WHI trials, for example -- the subgroup analyses were "limited and inconclusive," Nelson and colleagues wrote.
The analysis as a whole had several limitations, the researchers noted. Most outcomes of interest were reported in no more than two trials. Low retention and adherence to protocols were problems in most of the trials.In addition, the vast majority of trial participants were in their 60s, limiting applicability to women in menopause or immediately postmenopausal. Also, most of the trials used oral conjugated equine estrogens, raising questions about the effects of estrogens from other sources and delivered in other ways, such as transdermally. No timetable was given for release of the updated USPSTF recommendations.
Birth Control Patch on Par with Oral Meds
A low-dose investigational contraceptive patch appears to be as effective as combined oral contraceptives across a broad spectrum of women, researchers said. The overall Pearl Index score for women on the low-dose ethinyl estradiol and levonorgestrel patch was 4.96, compared with a score of 4.02 for women on combined oral contraceptive pills (20 μg ethinyl estradiol and 0.1 mg levonorgestrel), reported Andrew Kaunitz, MD, from the University of Florida College of Medicine in Jacksonville, and colleagues. The difference was not statistically or clinically meaningful, Kaunitz said during a presentation at the annual clinical meeting of the American College of Obstetricians and Gynecologists. The year-long, open-enrollment phase III trial of the AG200-15 contraceptive patch studied a population of women reflective of the general U.S. population, including obese women, minorities, smokers, and women with, and without, previous hormonal contraceptive use, the authors wrote. Women randomized to the AG200-15 arm applied the patch once weekly for 3 weeks, followed by a patch-free fourth week. A proprietary transdermal mechanism allows the low doses of estrogen and levonorgestrel to be absorbed through the skin. The calculated daily dose of the patch is equivalent to 30 μg of ethinyl estradiol. Women in the other study arm were treated for six cycles with combined oral contraceptives, which was then followed by seven cycles of the patch. Overall, 1,503 women with a mean age of 26.4 years were randomized. Racial/ethnic demographics were similar between the two groups with 55% white/non-Hispanic. The percentage of smokers also was similar in the two groups (27% and 29%). The mean body mass index (BMI) was 27.5. A majority (60%) were new users of hormonal contraceptives. Kaunitz noted that the Pearl Index - routinely used in clinical trials to measure effectiveness of contraceptives - was 2.85 for obese women with a BMI greater than 32 kg/m2 compared with an index score of 3.17 for women with a lower BMI. "There is a concern about attenuated efficacy that was observed in the first generation patch in obese women, so our finding here of no difference between heavier women and thin women is robust." "We did not see any failures rates based on body mass index." Kaunitz said that both investigators and patients' diaries showed that the patch adhered well, with few women experiencing patch fall-off. "It's a patch that sticks well, it stays on for seven days, and is not associated with irritation," he said.
Intrauterine Devices Better Than "The Morning After Pill" As Emergency Contraception
A systematic review of 35 years of data published online in Europe's leading reproductive medicine journal Human Reproduction shows that intrauterine devices (IUDs), commonly known as a 'coil' should be routinely used as emergency contraception, given that their failure rate is less than one per thousand and because it has proven more effective than the "morning after pill". When left in place, IUDs also continue to protect women from unwanted pregnancy for many more years. ?
The researchers analyzed data from 42 English and Chinese studies that were conducted between 1979 and 2011 in six countries. A 2006 report states that China has the highest IUD use in the world, with 43% of women using IUDs for contraception in comparison with 13% in the rest of the world. The studies involved 7,034 women and included eight different types of IUDs.
An IUD is a small device made from plastic and copper that a doctor or trained nurse inserts into the woman's womb. Depending on the brand, the device can remain in the womb for between five and ten years. In comparison with IUDs, which have been used as emergency contraception for over 35 years, scientists have also developed intrauterine systems (IUS) in recent years, which are small, plastic devices that release very low doses of the hormone progesterone.
First study author, Ms Kelly Cleland, a staff researcher at the Office of Population Research at Princeton University in the USA declared:
"Unintended pregnancies are a significant health problem worldwide. It is estimated that globally at least 36% of pregnancies are unintended. We already know from previous research that IUDs are very cost-effective forms of regular contraception. This study is the most comprehensive review to date of the efficacy of IUDs used for emergency contraception, and our results provide clear evidence that they are a highly effective method of emergency contraception, as nearly 100% of users overall did not become pregnant after unprotected sex when an IUD was inserted post-coitally.
In contrast, failure rates are at least 10-20 times as high for emergency contraceptive pills such as ulipristal acetate and levonorgestrel. IUDs also offer very effective ongoing contraception. Therefore, we conclude that IUDs should be included routinely as an emergency contraceptive option whenever feasible and appropriate."?
As an emergency contraception, IUDs should normally be inserted within about five days of unprotected intercourse, which occurred in 74% of the studies, however, the current review's timeframe ranged from between two and ten days to more. ? ?
A total of ten pregnancies occurred from 7,034 post-coital IUD insertions, six of which occurred amongst 5,629 women in China, whilst the other four pregnancies occurred in 200 women in one Egyptian study.
According to the researchers, the Egyptian study's unusual and abnormal results made it an "outsider" study, which may have been due to the way the women were selected and should therefore be ignored for the purposes of their review.
The researchers explain:
"This high failure rate can possibly be explained by the fact that women were specifically selected if they had had intercourse around the time of ovulation; in any event Egypt is a clear outlier. If the unusual results from the Egypt study were excluded, the overall failure rate would be 0.09% . . .; this is our preferred estimate."
The "morning after pill" (ulipristal acetate) is the second most effective form of contraception, with a failure rate of about 1-2%, followed by levonorgestrel, with a failure rate of around 2-3%. Unlike IUDs, both pills, ulipristal acetate and levonorgestrel, become less effective the higher a woman's body mass index (BMI) is. ? ?
Although IUDs are evidently the most effective means of emergency contraception, studies have shown that both doctors and patients do not seem to be sufficiently aware of IUDs, which are therefore rarely used in this situation. According to a US study, 85% of clinicians never recommended IUDs as an emergency contraception and 93% require at least two visits in order to insert an IUD. ?
Professor James Trussell, Professor of Economics and Public Affairs at Princeton University and Visiting Professor at The Hull York Medical School in York, UK, who was involved in the research, declared:
"This is an extremely difficult problem to deal with, especially as in many countries women can just go to their local pharmacy to obtain the 'morning after pill', but virtually no women know to ask for an IUD and many family planning clinics and surgeries do not offer same-day insertion. Offering same-day insertion would remove a huge barrier to the greater use of IUDs."? ?
Furthermore, upfront costs of IUDs are comparatively high, with a cost from between $718 for the ParaGard IUD in the USA to about £10 for IUDs in the UK. However, over a certain time period IUDs prove more cost effective as compared with other forms of contraception, regardless of emergency or preventive contraception.
According to Prof Trussell:
"These initially higher costs are vastly offset by pregnancies prevented both in the contraceptive emergency itself and by pregnancies prevented by continued use of the IUD. 'Morning after pills' taken today protect against pregnancy from sex last night but not from sex a week from now."? ?
Ms Cleland concluded the study, saying:
"We hope that this study will encourage providers to consider IUDs for their patients requesting emergency contraception, and possibly to consider how to structure their clinic flow so that they are able to provide same-day insertions."?
Urinary Incontinence - Pelvic Floor Exercises Help Women
A report from the U.S. Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ), reveals that adult women who suffer from urinary incontinence can benefit by performing pelvic floor muscle training exercises that have no adverse effects. The report also found that although medication treatments can be effective, their benefits are low and adverse effects are common. The report, published in Annals of Internal Medicine, is a comparative effectiveness review prepared for AHRQ's Effective Health Care Program by the Minnesota Evidence-based Practice Center. Carolyn M. Clancy, M.D., AHRQ Director, explained:
"Urinary incontinence can affect women in a variety of ways, including physically, psychologically and socially - and some of these impacts can be severe. This new report will help women and their clinicians work together to find the best treatment option based on each patient's individual circumstances."
Approximately 25% of young women, up to 57% of middle-aged and postmenopausal women, and around 75% of older women in nursing homes suffer from urinary incontinence. Urinary incontinence can inflict considerable and potentially debilitating lifestyle restrictions. In 2004, the United States spent around $19.5 billion on incontinence care. In addition, one estimate reveals that the annualized cost of women's nursing home admissions due to urinary incontinence was $3 billion and 6% of nursing home admissions of older women were due to urinary incontinence. In this study, the team focused on stress incontinence and urgency incontinence. Stress incontinence is the inability to retain urine during sneezing or coughing and urgency incontinence is a sudden compelling urge to urinate that results in involuntary loss of urine. According to the researchers, both stress and urgency incontinence usually occur when the urinary sphincter fails, often due to weak pelvic floor muscles. Pelvic floor muscles support the bladder, uterus and other pelvic organs. The researchers found that exercises designed to increase the strength of the pelvic floor muscles (similar to Kegel exercises) were effective in a women's ability to hold their urine. These exercises, in addition to bladder training, improved both stress and urgency incontinence. Although the report found that estrogen treatment was effective in treating stress incontinence, it also had some adverse effects. Furthermore, another medication called duloxetine (antidepressant) was found to be ineffective and had a high risk of adverse effects. According to the report, the drugs reviewed were comparable in effectiveness, although more women discontinued treatment with some drugs as a result of adverse effects. The report will help patients and clinicians select the best treatment options with the most benefits and least harms, via its comprehensive information regarding each medications adverse effects. Even though there is significant evidence on clinical measures for treatment of the condition, such as grams of urine lost, there are less measures of quality of life associated to urinary incontinence and its treatments.
FDA Warns of Clot Risk with Yaz, Other OCs
Labels for oral contraceptives that contain drospirenone will now note that studies have shown as much as a threefold increase in risk of blood clots compared with other birth control pills, the FDA said. Following a safety review that began last May, the agency "has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills." The label changes apply to nine brand-name contraceptives -- Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah -- and two generic formulations, all of which include 3 mg of drospirenone and either 0.02 or 0.03 mg of ethinyl estradiol. Two (Beyaz and Safyral) also contain 0.451 mg of levomefolate calcium. However, the FDA stopped short of declaring that drospirenone definitely increases risk of venous clotting on the basis of current clinical data. "The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not," the agency said in a Drug Safety Communication. "The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills," according to the statement. Also, the FDA noted, the risk of clotting while using these products still appears to be lower than thrombosis risk during pregnancy and in the immediate postpartum period. The agency provided the following estimates of the clotting risk for different groups of women, per 10,000 person-years:
Nonpregnant women not using combination hormonal contraceptives: 1 to 5
Combination contraceptive users: 3 to 9
Pregnant women: 5 to 20
Postpartum period (through 12 weeks): 40 to 65
Most of the data on which the FDA based its new position had been available last year, but the agency could not then decide whether the increased risk was real. The agency had asked for help from its drug safety and reproductive health drugs advisory committees at a joint meeting in December. A slim majority of panel members -- 15 out of 26 -- said the benefits of drospirenone-containing contraceptives outweighed their risks. But the committees voted overwhelmingly for more information on the products' labels.
Generic Boniva Gets FDA OK
The FDA has approved the first generic versions of ibandronate (Boniva) tablets for the once-a-month treatment or prevention of osteoporosis after menopause. Approval was granted to Apotex, Orchid Healthcare, and Mylan Pharmaceuticals to market 150 mg generic ibandronate tablets, the agency said in a statement. Ibandronate is a bisphosphonate that helps increase bone mass, thus reducing the risk of fracture. Patients receiving the generics will get a medication guide listing the adverse events related to use of the drug, including esophageal problems, low blood-calcium levels, unusual thigh bone fractures, and other bone, joint, and muscle pain. Common adverse events include back pain, dyspepsia, extremity pain, diarrhea, headache, and myalgia.
Do Cervical Ca Tests Less Often, Task Force Says
Women ages 21 to 29 should undergo cervical cancer screening with Pap tests every three years and then every five years with Pap and HPV tests until age 65, according to updated clinical guidelines. Women younger than 21 and most women older than 65 should not be screened, as data have shown that screening does not reduce cervical cancer incidence or mortality in those groups, the guidelines say. Almost identical guidelines on the topic were issued simultaneously by the U.S. Preventive Services Task Force (USPSTF) and by a collaboration comprising the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. Both guidelines emphasize the need to balance benefits and potential risks associated with screening, according to representatives of the groups. "This is good news for women because evidence shows that an annual Pap smear is not necessary to prevent deaths from cervical cancer," Virginia Moyer, MD, of Baylor College of Medicine in Houston and chair of the USPSTF, said in a statement. "Screening every three years starting at age 21 saves the same number of lives as annual screening, but with half the number of colposcopies and fewer false-positive tests." The support for less frequent screening has nothing to do with saving money, according to the chair of the collaborative guideline group. "We were not allowed to consider the financial implications of screening," said Debbie Saslow, PhD, of the American Cancer Society. "We focused only on the evidence related to the benefits and the potential harms of screening." The USPSTF guideline was published online in Annals of Internal Medicine, and the collaborative guideline was published in CA: A Journal for Clinicians, the Journal of Lower Genital Tract Disease, and the American Journal of Clinical Pathology. The guidelines share most of the core recommendations, including:
No screening before age 21
Screening every three years with a Pap test only for women 21 to 29
No screening with HPV (human papillomavirus) tests before age 30
Screening every five years with a Pap test and HPV test for women 30 to 65 (every three years if only a Pap test is used)
No screening after 65, if a woman has tested negative on three consecutive Pap smears or on at least two HPV tests within the previous 10 years
No screening of women who have undergone hysterectomy for reasons unrelated to cervical cancer
No annual screening, by any method, for women of any age
Women who have been vaccinated against HPV infection should be screened in accordance with age-specific recommendations for unvaccinated women. Neither guideline applies to women who have a history of cervical cancer, in utero exposure to diethylstilbestrol, or who are immunosuppressed (including HIV-positive patients). Women who have an abnormal Pap test but negative HPV test can have a Pap test alone in three years or co-testing in five years. If a Pap test is negative but HPV is positive, the patient can be screened again with both tests in a year or screened specifically for HPV 16 and 18, the strains most closely associated with cervical cancer.
Birth Control Pills Recalled
Pfizer has recalled a total of 28 lots of Lo/Ovral and its generic equivalent because of a packaging error that may result in inadequate contraception. The affected lots of norgestrel and ethinyl estradiol tablets (Lo/Ovral 28 and Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg) may include some blister packs with inexact counts of inert and active-ingredient tablets, and tablets that are out of sequence, a statement from Pfizer said. The packs contain 28 tablets, including 21 with active ingredient and 7 inert tablets, which provide contraception when dispensed in a correct dosing schedule. The packaging error may place the daily dosing regimen out of order and, as a result, may put patients at risk for unintended pregnancy, the statement said. Such an error does not pose an immediate health risk, Pfizer added, but patients using the product should switch to a nonhormonal form of birth control. A full list of affected lot numbers is available in the
, and includes 14 lots of brand-name product and 14 lots of generic product. Patients with an affected product should consult a healthcare professional and return the product to a pharmacy. The contraceptives were manufactured and packaged by Pfizer and marketed and labeled by Akrimax Rx Products.
Canadian Panel Nixes Mammograms for Women in Their 40s
Women ages 40 to 49 do not need routine breast cancer screening with mammography, according to a Canadian preventive care task force. Breast cancer screening for women of average risk in that age group results in a "relatively small" mortality benefit, which may be countered by an increased risk of overdiagnosis and unnecessary treatment. In the final analysis, however, the decision to undergo screening mammography should remain with the individual patient and treating physician, who should thoroughly discuss the tradeoff between benefits and harms, as well as patient preferences, the guideline authors wrote.
"We have recommended a screening interval of every two to three years for women 50 to 74 years of age using available evidence from randomized, controlled trials," Marcello Tonelli, MD, of the University of Alberta in Edmonton, and co-authors from the Canadian Task Force on Preventive Care wrote in conclusion. "The concept of individualizing the interval for screening with mammography based on breast density or other risk factors is appealing but requires further study." "Finally, given the importance of patient preferences for appropriate decision-making, further studies are needed to determine the best way to communicate information about the potential benefits and harms of mammography." In an accompanying editorial, a Danish physician urged elimination of breast cancer screening altogether.
Citing evidence of overdiagnosis and unnecessary testing and treatment resulting from mammographic screening, Peter C. Gotzsche, MD, of the Nordic Cochrane Center in Copenhagen, wrote, "If screening had been a drug, it would have been withdrawn from the market." The Canadian guidelines add another log to the opinion fires that have flared off and on since the U.S. Preventive Services Task Force (USPSTF) made similar recommendations in 2009. Debate over the need for screening mammography in women ages 40 to 49 continued through 2010, with multiple individuals and organizations taking sides. The debate has shown no signs of losing steam. Last summer, the American College of Obstetricians and Gynecologists came out in support of mammographic screening beginning at age 40. The Canadian task force found no evidence to support screening before age 50 for women at average risk. Members of the task force made the decision after updating and evaluating the systematic review the USPSTF performed before recommending age 50 for the start of routine mammographic screening. The analysis showed that 2,108 women ages 40 to 49 would have to be screened every two to three years to prevent one breast cancer death. Screening that younger age group would lead to 690 false-positive mammography results and 75 unnecessary breast biopsies, the task force members wrote. In contrast, the number needed to screen (NNS) dropped to 721 for women ages 50 to 69. Those women would incur 204 false-positives and 26 unnecessary biopsies.
Among women ages 70 to 74, mammography had an NNS of 451, false-positive results in 96 cases, and 11 unnecessary biopsies. The task force made no recommendation regarding mammographic screening in women 75 and older, citing a lack of data to guide decision making. Consistent with its U.S. counterpart, the Canadian task force recommended against routine use of MRI for breast cancer screening and against routine clinical breast examinations, and recommended that clinicians not advise women to perform breast self-examination on a routine basis. Authors of the guidelines emphasized that the recommendations apply only to women with an average risk of breast cancer. In the editorial, Gotzsche lauded the guidelines as "an important step in the right direction, away from the prevailing attitude that a women who does not undergo screening is irresponsible." He cited the following recent studies suggesting "that it may be most wise to avoid screening altogether, at any age":
A Danish study showed that women ages 55 to 74 who had regular mammography had a 1% annual decrease in breast cancer mortality, as compared with a 2% decrease each year in an unscreened population (BMJ 2010; 340: c1241)
A study covering much of Europe that showed a 37% decline in breast cancer mortality from 1989 to 2005 that began before many of the countries had organized screening programs (BMJ 2010; 340: c4480, c3620)
An analysis of six European countries that introduced breast cancer screening 10 to 15 years apart and showed no relationship between the start of screening and breast cancer mortality. In fact, all of the countries had similar breast cancer mortality (BMJ 2011; 343: d4411)
More Blood Clots Seen With Newer Birth Control Pills
Newer forms of progesterone in combination hormonal contraceptives carry higher venous thromboembolic (VTE) risk than older forms, a population-based study affirmed. Women on the pill with the older, levonorgestrel version were at three times the risk of VTE as those not on any hormonal contraception, said Ojvind Lidegaard, MD, of Rigshospitalet at the University of Copenhagen, Denmark, and colleagues. But oral contraceptives containing desogestrel, gestodene, drospirenone, or cyproterone boosted the risk six to seven times over that of non-users.
The number needed to treat with levonorgestrel instead of the other progesterone forms to prevent one VTE in one year was about 2,000. These findings from national registry data in Denmark from 2001 through 2009 -- after the launch of the newest synthetic progesterone, drospirenone, in that country -- largely matched results of their earlier analysis from 1995 through 2005. Other studies over the decades also have found almost universally elevated VTE risk with hormonal contraception, with the estrogen and progestogen (synthetic progesterone) components both appearing to play a role. But the absolute risks remain small, at about 10 in 10,000, for current users of even the newer pills, noted Philip C. Hannaford, MD, of the University of Aberdeen, Scotland, in an accompanying editorial. The risks appear real and may lead many clinicians to prescribe a combined oral contraceptive with levonorgestrel whenever possible, he wrote. "It is crucial, however, not to exaggerate the risk -- oral contraceptives are remarkably safe and may confer important long term benefits in relation to cancer and mortality," Hannaford cautioned. The updated analysis included more than 1.2 million non-pregnant 15- to 49-year-old women in Denmark without a history of thrombotic disease. Data came from national vital status, inpatient, cause of death, and pharmacy registries. From 2001 to 2009, 4,307 first-ever VTEs occurred in this cohort. Most were deep vein thrombosis only (63.6%) or pulmonary embolism with or without deep vein thrombosis (26.2%). Compared with women not taking hormonal contraception, confirmed venous thromboembolism was elevated for users of oral contraceptives containing 30 to 40 μg ethinylestradiol plus the following:
Levonorgestrel, with a relative risk of 2.9 (95% confidence interval 2.2 to 3.8)
Desogestrel, with a relative risk of 6.6 (95% CI 5.6 to 7.8)
Gestodene, with a relative risk of 6.2 (95% CI 5.6 to 7.0)
Drospirenone, with a relative risk of 6.4 (95% CI 5.4 to 7.5)
With levonorgestrel-containing pills as the comparator, rate ratios of confirmed venous thromboembolism adjusted for length of use were:
2.2 with desogestrel (95% CI 1.7 to 3.0)
2.1 with gestodene (95% CI 1.6 to 2.8)
2.1 with drospirenone (95% CI 1.6 to 2.8)
Progestogen-only pills (low-dose norethisterone or desogestrel alone) or hormone-releasing intrauterine devices didn't have any impact on VTE risk compared with non-users. Lower estrogen doses were associated with modestly lower VTE risk for oral contraceptives with norethisterone, levonorgestrel, desogestrel, or gestodene but not with drospirenone, the investigators reported. Phasic combined oral contraceptives with levonorgestrel slightly, but not significantly, increased VTE risk compared with levonorgestrel plus 30-μg of ethinylestradiol (relative risk 2.28 versus 2.19), which the researchers suggested "could be due to the slightly higher total dose of estrogen in the former group." The results appeared stable through the study period. The researchers noted that their results wouldn't have been affected by recall bias or "left censoring," but lack of data on body mass index and family disposition may have contributed to some residual confounding.
Pap Tests Needed Only Every 3 Years, Task Force Says
Healthy women younger than 65 need a Pap test only every three years, the U.S. Preventive Services Task Force said. The recommendation is meant to address the concern that many women were being tested too frequently, which could lead to overtreatment of low-grade lesions that might not prove to be cancerous. The task force "found no direct evidence that annual screening achieves better outcomes than screening every three years," wrote the authors of the recommendation. "Modeling studies suggest little added benefit of more frequent screening for most women." In addition, too frequent screening can result in increases in cost and in women having needless anxiety because of false positive results. The task force also recommended that screening begin for all women at age 21 regardless of their sexual activity levels, which reflected a change from the task force's 2003 recommendation stating that screening should begin at age 21 or within three years of the initiation of sexual activity. "Although there is little value in screening women who have never been sexually active, many U.S. organizations recommend routine screening by age 18 or 21 for all women, based on the generally high prevalence of sexual activity by that age in the U.S. and concerns that clinicians may not always obtain accurate sexual histories," the task force noted. It has become clear that invasive cervical cancer is rare among women younger than 20, as the authors explained in a recent article in the Annals of Internal Medicine. As for which screening methodology to use, the recommendations stated that newer FDA-approved technologies, such as liquid-based cytology, "may have improved sensitivity over conventional Pap smear screening, but at a considerably higher cost and possibly with lower specificity." In the absence of studies that address cervical cancer outcomes, the available data on the accuracy of new technologies "were insufficient to determine whether they are more effective than conventional cervical cytology for preventing invasive cervical cancer," the task force noted. The task force also reported that little evidence exists supporting continuation of screening for women older than 65 if their recent Pap smears have been normal and they are not at risk for cervical cancer. Similarly, screening is unnecessary in women who have had a hysterectomy for benign disease. They cautioned that "clinicians should confirm that a total hysterectomy was performed (through surgical records or inspecting for absence of a cervix); screening may be appropriate when the indications for hysterectomy are uncertain." The recommendations also emphasize that more efforts should be made to identify and reach out to women who have not undergone screening.
Oral Contraceptives Pulled Over Packaging Error
Generic drugmaker Qualitest Pharmaceuticals pulled several lots of a number of oral contraceptives due to a packaging error that obscured the products' lot number and expiration date. Affected products contained a blister that had been rotated 180 degrees on the card it was packed on, thereby reversing the weekly tablet orientation and hiding the expiration date, a company statement issued Thursday said. Qualitest's statement added that the error may cause the contraceptive regimen to be incorrect and may result in unintended pregnancy. The recalled products include:
Gildess FE 1.5/30
Gildess FE 1/20
A full list of affected product lots is available online
. Patients with affected product should use non-hormonal contraception and consult a healthcare professional about the issue. The statement noted patients with affected product are not at immediate health risk beyond potential lack of hormonal contraception.
FDA Approves Roche's HPV Test For Identifying Women At Highest Risk For Cervical Cancer
The FDA has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test will help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease.The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing. It individually identifies genotypes 16 and 18, the two highest-risk HPV genotypes responsible for more than 70 percent of cervical cancer cases, while simultaneously detecting 12 other high risk HPV genotypes. The approval was based on data from the ATHENA study involving more than 47,000 women in the U.S. Results demonstrated that 1 in 10 women, age 30 and older, who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical pre-cancer even though they showed normal results with the Pap test."The FDA approval of the cobas HPV Test demonstrates the value of simultaneous HPV 16 and 18 genotyping in cervical cancer screening," said Daniel O'Day, Chief Operating Officer of Roche Diagnostics. "We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening."More than 55 million Pap cytology ("Pap smear") tests are performed in the U.S. annually. Current guidelines for screening allow for either cytology or cytology plus HPV testing to determine the risk of cervical cancer. However, HPV testing, and 16 and 18 genotyping in particular, identifies more women at risk earlier than Pap cytology testing alone."Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, can provide predictive information about a woman's risk for having cervical pre-cancer or cancer," said Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology, at the University of Virginia Health System. "The cobas HPV Test provides physicians with a validated tool that helps them make early and more informed decisions regarding patient care."About the cobas HPV Test and cobas 4800 SystemThe cobas HPV Test is a qualitative in-vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). It is now available in the U.S. and all countries accepting a CE mark.The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests for HPV infections meeting the needs of the majority of clinical labs.
Women Living, Working in Smoke-Free Environments Have Lower Breast Cancer Rates
Women in smoke-free homes and workplaces are less likely to develop or die from breast cancer, according to a study in the journal
. Researchers compared rates of non-smoking homes and workplaces with state-specific rates of breast cancer incidence and death and found that states with higher numbers of smoke-free homes and workplaces had significantly fewer breast cancer deaths, particularly among younger premenopausal women. The study authors estimated that about 20% of the change in breast-cancer death rates is due to changes in smoke-free home and workplace policies.
FDA Approves Generic Birth Control Pill
The FDA has approved a new generic oral contraceptive called Emoquette, a daily tablet that combines the hormonal compounds desogestrel and ethinyl estradiol to prevent pregnancy in women. Made by Qualitest Pharmaceuticals, Emoquette is a generic of Ortho-McNeil Pharmaceutical's oral contraceptive Ortho-Cept and Organon USA's Desogen. Because Emoquette is a generic drug, it wasn't subject to the same type of approval process as is a brand-name oral contraceptive. It was approved through the FDA's abbreviated new drug application process, which requires only that the drugmaker prove it is comparable to an innovator drug in dosage, route of administration, quality, performance, and intended use. Emoquette is the therapeutic equivalent of four other birth control pills currently on the market.
FDA Approves Second Oral Contraceptive With Folate
The FDA has approved a second oral contraceptive fortified with folate - Safyral - containing drospirenone, ethinyl estradiol, and levomefolate calcium. The agency's backing of Safyral follows approval of the similarly-formulated Beyaz in September. Both drugs are manufactured by Bayer HealthCare Pharmaceuticals.
Number of Females Suffering Knee Injuries Reaching "Astronomical Levels"
The number of overuse injuries among females has reached astronomical levels. In fact, more than 20,000 high school girls suffer a serious sports-related knee injury each year in the"US, with girls being seven times more likely to injure their anterior cruciate ligament (ACL) than boys in similar sports. Although the reason for the increased susceptibility is not clear, many orthopedic surgeons seem to agree the underlying reasons are at least five-fold: 'year-round participation without time for rest' and repair; the lessening of the gap between young men and women participating in athletic sports; girls tending to have less neuromuscular control of knee motion than boys while performing certain athletic tasks; the dramatic increase in the speed, power and intensity with which female athletes are playing, and the numerous anatomical and hormonal differences between men and women.
FDA Approves New Oral Contraceptive
Warner Chilcott announced that the FDA has approved LO LOESTRIN™ FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) for the prevention of pregnancy. LO LOESTRIN FE is a novel oral contraceptive that offers women the lowest dosage of estrogen (10 mcg) of any oral contraceptive currently available in the U.S. market. The company anticipates the commercial launch of LO LOESTRIN FE in early 2011. About LO LOESTRIN FELO LOESTRIN FE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Company Halts 'Female Viagra' Development
Pharmaceutical company Boehringer Ingelheim announced it is halting development of flibanserin (Girosa), a pill to treat female hypoactive sexual-desire disorder (HSDD). The decision to stop development of the drug dubbed "female Viagra" or "pink Viagra" follows an June meeting of an FDA advisory committee during which the panel voted 9 to 2 that flibanserin doesn't seem to work any better at increasing female sexual desire than placebo. The committee also voted 11 to 0 that the company failed to demonstrate that the benefits of flibanserin outweigh the risks, which include fainting, accidental injury, insomnia, and fatigue. Boehringer Ingelheim said in a statement that it will complete its two most advanced studies in order to "add knowledge for the scientific community and women suffering with HSDD" but it will discontinue the rest of its flibanserin development program. "The need for a better understanding of HSDD and its possible treatment continues, and we hope the scientific and medical communities will build on the knowledge that Boehringer Ingelheim's research has provided to find solutions for women who suffer with this disorder," said Michael Sand, director of clinical research at Boehringer Ingelheim. While the FDA's advisory committee felt flibanserin isn't ready for prime time, it agreed that HSDD -- the existence of which has itself been called into question -- is a legitimate medical disorder that deserves an FDA-approved treatment. Boehringer Ingelheim originally submitted to the FDA two prospective, randomized, double-blind North American trials that compared two doses of flibanserin with placebo in premenopausal women with HSDD for 28 weeks. In both trials, the groups that used flibanserin showed a significantly greater number of satisfactory sexual events than the placebo groups. About 30% to 40% of women in the flibanserin group reported a greater number of satisfactory sexual events, compared with 15% to 30% in the placebo arm. But those differences, although statistically significant, are not big enough to be "compelling," wrote FDA staff reviewers in briefing documents released in advance of the advisory committee meeting. Both studies failed to demonstrate a statistically significant improvement on the coprimary endpoint of sexual desire, as measured by e-diaries. In addition, flibanserin appeared linked with side effects, including dizziness and nausea. About 15% of women on the drug stopped taking it because of a side effect, compared with 7% of women in the placebo group. Although it has been referred to as the "female Viagra," the drug works through an entirely different mechanism than the selective vasodilators now used for male erectile dysfunction. Flibanserin is a serotonin 2A receptor antagonist and an agonist of the serotonin 1A and dopamine D4 receptors. The drug was originally developed as an antidepressant. Although animal experiments had suggested it might have a more rapid effect than serotonin reuptake inhibitors, it failed to substantially reduce depression symptoms in men and women in a clinical trial. However, the potential to increase female sexual desire became apparent during the study. Reportedly, trial participants were reluctant to return unused pills when the study was over. The company said it remains convinced of the "positive benefit-risk ratio of flibanserin for women suffering with HSDD," but that it would begin to reallocate its money elsewhere, including stroke, diabetes, and cancer research.
Folate-Fortified Birth Control Pill Approved
The FDA has approved an oral contraceptive containing folate to help prevent birth defects after women go off the pill. Called Beyaz, the product contains the same estrogen-progestin combination as the contraceptive pill Yaz -- plus 0.451 mg of levomefolate calcium. Levomefolate calcium is a metabolite of folic acid. Supplementation with this B-vitamin is recommended for all women of childbearing age because low folate levels are associated with neural tube defects such as spina bifida, the FDA said in a release announcing approval of Beyaz. The Yaz product is approved for preventing pregnancy and treating symptoms of premenstrual dysphoric disorder or moderate acne in women wanting to use an oral contraceptive. Those approvals also apply to Beyaz, along with the new indication of raising folate levels in oral contraceptive users for preventing neural tube defects in offspring conceived while using the product or shortly after discontinuing it, according to the FDA press release. The product's manufacturer, Bayer HealthCare Pharmaceuticals, pointed out that both products are 99% effective in preventing pregnancy when used as directed. As with other oral contraceptives based on hormone combinations, Beyaz should be avoided by women older than 35 who smoke because of increased risk of cardiovascular events. The FDA said clinical trials with Beyaz indicated the same overall safety profile seen with Yaz.
New Morning After Pill Approved By FDA
A new morning after pill, also known as an emergency contraception pill, called Ella (ulipristal acetate) has been approved in tablet form by the US Food and Drug Administration (FDA). It has been approved as a prescription-only-product, and prevents pregnancy if taken within five days after unprotected sexual intercourse or contraceptive failure. As a progesterone agonist/antagonist, Ella's main likely effect is to inhibit or delay ovulation. It is known as EllaOne in Europe, where it has been on the market since May 2009, the FDA informs. Possible side effects, reported from the clinical trials, include nausea, abdominal pain, headache, dysmenorrhea (menstrual cramps, period pains), and dizziness - similar to those found in other FDA-approved levonorgestrel emergency contraceptives.The product label says that women with known or suspected pregnancy, as well as breastfeeding mothers should not use Ella.
Female Study Participants Prefer Testing For Sexually Transmitted Infections At Home
By a large margin, women preferred to test for sexually transmitted infections at home, rather than at a clinic, Washington University researchers found after interviewing 462 women enrolled in the Contraceptive Choice Project. And those who chose a home test were twice as likely to complete the test as those who said they'd prefer to go to a free clinic or their healthcare provider. Even so, more than 40% of the women in the study did not follow through on annual screening for Chlamydia trachomatis and Neisseria gonorrhoeae, a trend that illustrates the difficulty of getting young women to adhere to certain recommendations.
Women May Be More Likely Than Men to Have Exclusively Noncalcified Coronary Plaques
Women are more likely than men to have exclusively noncalcified coronary plaques and are less likely than men to have calcified or mixed-composition plaques, which may in part explain why women are at lower risk of cardiac events, according to a study published in the American Journal of Cardiology. The research demonstrates that women have a lower calcified and mixed plaque burden, but no differences in noncalcified plaque compared with men across all age groups. Additionally, despite the similar overall noncalcified plaque burden, women had a greater proportion of noncalcified plaques to total plaques.
Breast Imaging Experts Recommend ammograms at Age 40
According to new joint guidelines from the American College of Radiology and the Society of Breast Imaging, experts are now saying that women who run an "average" risk of breast cancer should begin screening for the disease at age 40, while those who are deemed to be at "high risk" for breast cancer should begin screening at age 30. The guidelines run contrary to controversial guidedance in November from the U.S. Preventive Services Task Force, which recommended against routine mammograms for women in their 40s. "The significant decrease in breast cancer mortality, which amounts to nearly 30 percent since 1990, is a major medical success and is due largely to earlier detection of breast cancer through mammography screening," says Carol H. Lee, MD, of Memorial Sloan-Kettering Cancer Center's radiology department."For women with the highest risk of developing breast cancer, screening technologies in addition to mammography have been adopted," said Lee, who co-authored the guidelines.
FDA Okays Low-Dose Local Estrogen
The FDA has approved a low-dose local estrogen therapy, a 10 mcg formulation of the estradiol vaginal tablet Vagifem, for atrophic vaginitis. The therapy was first approved in a 25 mcg dose in 1999. In studies, the most common side effects among patients using the estradiol tablets were vulvovaginal mycotic infection, back pain, and vulvovaginal pruritus. Side effects associated with estrogen treatment in general include increased risk of uteral cancer, including vaginal bleeding associated with cancer, stroke, blood clot, headache, breast pain, irregular vaginal bleeding or spotting, stomach and abdominal cramps, bloating, nausea, hair loss, fluid retention, and yeast infection. Patients taking estrogens with progestins may face an increased risk of myocardial infarction and breast cancer. Patients 65 and older may be at increased risk of developing dementia while on estrogens with or without progestins.
Senate Affirms Screening Mammography for Women in Their 40s
On Thursday, Senators voted on an amendment that would require insurers to cover mammograms for women ages 40-49, essentially deciding to disregard the U.S. Preventive Services Task Force’s recent recommendation that women under 50 shouldn't undergo routine mammograms. This deals a significant blow to the power and credibility of the USPSTF. The amendment would increase coverage and eliminate copays for more women's preventive services. The USPSTF recommendations on any given procedure are important because the healthcare reform bill that was passed by the House and the bill being considered by the Senate would require insurance companies to cover all medical services that receive a grade of "A" or "B" from the USPSTF. In its recent recommendations, the task force downgraded mammography in women under 50 to a "C" grade, which means there is limited evidence to support its use. That would mean that insurance plans wouldn't be required to cover screening mammography for those women, unless the secretary of Health and Human Services (HHS) used her discretionary power to require plans to cover services with lower grades.
New Guidelines for Pap Smears
The American College of Obstetricians and Gynecologists says that women in their 20s can have a Pap smear every two years instead of annually. The recommendations are based on scientific evidence that suggests more frequent testing leads to overtreatment, which can harm a young woman's chances of carrying a child full term. Dr. Thomas Herzog of Columbia University in New York, who is chairman of an ACOG subcommittee on gynecologic cancers stated that "Overtreatment of minor abnormal pap tests in young women and adolescents can lead to consequences such as preterm labor in some cases." 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've 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.
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