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Controversial Changes in Screening for Breast Cancer
The U.S. Preventive Services Task Force (USPSTF) has recommended against routine screening mammography in women aged 40–49 years. Women aged 50–74 years should receive biennial screening mammograms. The Task Force found insufficient evidence to assess the benefits and harms of mammography in women aged 75 years or older. The USPSTF also recommended against teaching women breast self-examination, saying that adequate evidence suggests that teaching BSE does not reduce breast cancer mortality. The report cites harm associated with screening, such as psychological distress, inconvenience, and unnecessary imaging tests and biopsies associated with false-positive screening results, which are higher in younger women, as rationale for the change in its recommendations. In addition, overdiagnosis and exposure to radiation were listed as concerns. The Task Force also concluded that evidence is lacking in determining the benefits and harms of digital mammography and magnetic resonance imaging as replacements for mammography.
First Cervical Cancer Screening Delayed until Age 21
The American College of Obstetricians and Gynecologists (ACOG) has issued new guidelines recommending that women should first receive a cervical cancer screening at age 21, women younger than 30 years should receive a screening using the standard Pap test or liquid-based cytology every 2 years, and women 30 years and older who have had three consecutive negative cytology tests may be rescreened every 3 years. Alan G. Waxman, M.D., at the University of New Mexico in Albuquerque, who headed the development of the document by ACOG's Committee on Practice Bulletins-Gynecology, said that scientific evidence does not support the traditional annual Pap test and that screening at less frequent intervals will prevent cervical cancer just as well at less cost while avoiding unnecessary interventions. The Committee said raising the baseline screening to age 21 would avoid unnecessary treatment of adolescents, which can have economic, emotional, and future childbearing implications. Although human papillomavirus (HPV) infection rates are high among sexually active adolescents, most of their immune systems can clear the infection within 1–2 years, and invasive cervical cancer is rare in women younger than age 21. Because of an immature cervix, however, adolescents have a high incidence of HPV-related dysplasia, and women treated with an excisional procedure for the dysplasia have an increased risk of premature birth. Women with HIV infection who are immunosuppressed, were exposed to diethylstilbestrol in utero, and have been treated for cervical intraepithelial neoplasia (CIN) 2, CIN 3, or cervical cancer should be screened more frequently. Women who have undergone a total hysterectomy, including the cervix, for a noncancerous condition and who have no history of high-grade CIN can discontinue routine cervical cytology testing. At age 65 or 70, women who have three or more negative cytology results in a row and no abnormal test results in the past 10 years can forego screenings.
Specialized Cooperative Centers Program in Reproduction and Infertility Research
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has reissued a request for applications for Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54). Applications must be received by May 5, 2010. The NICHD intends to commit approximately $5.5 million in total costs in fiscal year 2011 to fund up to three new or renewal applications. Total project periods may not exceed 5 years, and direct costs in the first year are limited to $1.4 million. This funding opportunity is designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality and to form a cooperative network with NICHD. Topics of research that will be considered include reproductive developmental biology, reproductive track biology and physiology, reproductive endocrinology and neuroendocrinology, reproductive genetics and epigenetics, and reproductive medicine.
CDC Releases Estimated Pregnancy Rates
The National Center for Health Statistics, part of the Centers for Disease Control and Prevention, reported that in 2005 an estimated 6.4 million pregnancies resulted in 4.14 million live births. There were approximately 1.21 million induced abortions and 1.06 million fetal losses. The pregnancy rate for women aged 15–44 years was 103.2 pregnancies per 1000 women, 11% below the 1990 peak of 115.8 but close to the rate in 1976, which was 102.7. Pregnancy rates for married women fell 8% from 1990 to 2005, and the rate for unmarried women dropped 11%. Teenage pregnancies have declined 40% from 1990 to 2005, to 70.6 pregnancies per 1000 women aged 15–19 years, the lowest rate since the government began keeping pregnancy statistics in 1976. Teenage abortions were down 53%, and live births were down 32%. From 1990 to 2005, the pregnancy rate declined 48% for teens aged 15–17 years and 30% for young women aged 18–19 years. Pregnancy rates declined by 47% for black teenagers, 49% for white non-Hispanic teenagers, and 23% for Hispanic teenagers.
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid) (Xanodyne Pharmaceuticals, Newport, KY) to treat menorrhagia. Lysteda, an antifibrinolytic agent, was first approved as an injectable agent, called Cyklokapron, to reduce or prevent bleeding during and after tooth extraction in patients with hemophilia. It is the first nonhormonal drug approved as a menorrhagia treatment. About 3 million reproductive-aged U.S. women suffer from heavy menstrual bleeding each year. Some of the bleeding is related to uterine fibroids, but most cases have no underlying cause. “Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA's Associate Commissioner of Women's Health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.” During clinical trials, women taking Lysteda reported headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda compared with those taking a placebo. Lysteda taken with hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack. The FDA cautioned that the drug should be taken by these women only if there is a strong need and the benefits will outweigh the increased clotting risk.
FDA Approves New Vaccine for Prevention of Cervical Cancer
The U.S. Food and Drug Administration approved a second vaccine, Cervarix (GlaxoSmithKline, Brentford, Middlesex, U.K.), to prevent cervical cancer and precancerous lesions caused by the human papillomavirus (HPV) types 16 and 18. It approved its use in girls and women aged 10–25 years. During the primary clinical study investigating Cervarix, the vaccine was about 93% effective in preventing precancerous cervical lesions caused by these HPV types in women who were not infected at the start of the study. Among all participants, including those testing positive for HPV 16 or 18, Cervarix was about 53% effective in preventing the lesions from developing. Current data indicate that Cervarix provides protection for about 6.4 years. Cervarix contains the adjuvant ASO4, a combination of aluminum hydroxide and monophosphoryl lipid A (MPL). It is the first vaccine the FDA has licensed that includes MPL as an adjuvant. Commonly reported adverse reactions during the trials included pain, redness, and swelling at the injection site, fatigue, headache, muscle and joint aches, and gastrointestinal distress. Cervarix is administered in three separate injections, with the initial dose being followed by two additional shots 1 and 6 months later.
Publication Features Women in Science Careers at the NIH
The National Institutes of Health Office of Research on Women's Health (ORWH) with assistance from the members of the NIH Coordinating Committee on Research on Women's Health has released a new publication showcasing the achievements of some of the accomplished women working at the NIH. Women in Science at the National Institutes of Health 2007–2008 aims to promote diversity. The book features 289 doctoral-level women in a variety of roles at the NIH. Readers will learn about the different paths the women have taken, such as starting their education at a community college, attending graduate school in midlife, and raising children alone. “I have personally been inspired by these women scientists, who have earned the great respect with which they are regarded, both by those in the NIH community as well as by those in the greater scientific community,” said Vivian W. Pinn, M.D., NIH Associate Director for Research on Women's Health and Director of ORWH. “Rather than a directory of the totality of women scientists at the NIH, this effort is meant to highlight examples of the variety of roles, positions, and contributions of doctoral-level women across the NIH.”
Deborah E. Powell Named AAMC Chair
Surgical pathologist Deborah E. Powell, M.D., Associate Vice President for new medical education programs and Dean Emeritus of the University of Minnesota Medical School, began serving as chair of the Association of American Medical Colleges in November 2009. Dr. Powell brings more than 30 years experience in medical education to the post, which she will hold for 1 year. Dr. Powell cofounded the Institute for Engineering in Medicine at the University of Minnesota Medical School. She received her medical degree from Tufts University School of Medicine in Boston, completed her residency at Georgetown University Medical Center in Washington, DC, and the Clinical Center of the National Institutes of Health in Bethesda, MD, and had worked at the University of Kentucky in Lexington and the University of Kansas prior to joining the University of Minnesota Medical School in 2002.
WHO Releases Women's Health Report
The World Health Organization released the report, Women and Health: Today's Evidence Tomorrow's Agenda, and called for urgent action within the healthcare community and beyond to improve girls' and women's lives throughout their life span. The organization found widespread and persistent inequities and disparities of care between men and women and between high-income and low-income countries and variances within countries affected by social and economic factors. WHO called sexuality and reproduction central to women's health, yet cited many health challenges during a woman's reproductive years, including unwanted pregnancies, unsafe abortions, complications of pregnancy and childbirth, sexually transmitted diseases, and a significant risk of violence. Traffic injuries, burns, and suicide pose risk of death in many countries. Women aged 60 years or older face possible cardiovascular disease and chronic illnesses. WHO considers that a fair start for girls is critical to women's health, with many conditions having their roots in childhood. The organization said that societies and their health systems are failing women and depriving them of needed care while at the same time depending on women as providers.
Economics of Fertility Treatment
The motivations and expectations of women applying to serve as egg donors have not dramatically changed from before the economic meltdown, reported American Society for Reproductive Medicine President-Elect William Gibbons, M.D., at the Society's annual conference in the fall of 2009. A team from Reproductive Medicine Associates of New York and Mount Sinai School of Medicine compared 54 egg donor applicant interviews from 2002–2004 with 46 from 2008. The same person conducted the interviews at both times, using the same questionnaire. Age, education level, marital status, and religion remained constant. The greatest difference was in how the women planned to spend the compensation, with 57% of the women in 2008 saying they would use it for schooling, compared with 28% in 2002–2004. The number of women planning to pay down debt decreased from 32% in 2002–2004 to 21% in 2008, and those planning to save the funds dropped from 20% to 11%. “Although more women may be entertaining the idea of donating eggs and seeking information on the procedure, the ones who follow through to the next step are similar to the women who have been donors in the past,” Dr. Gibbons said. The New York team also reviewed records of patients with stored frozen embryos and found that the number of people discontinuing storage was similar from October 2006 through September 2008. Starting in October 2008, however, more patients disposed of their embryos, something the researchers concluded was associated with the economy.
Sex and Gender Study to Determine Factors Affecting Women's Health
The National Institute of Diabetes and Digestive and Kidney Diseases is conducting a clinical project designed to increase clinicians' understanding of urinary tract infections (UTI) in women, which occur in about 7–11 million women each year. Approximately 20%-30% of women suffer from frequent recurrent infections. The researchers will prospectively follow a large group of women with recurrent UTI to determine the relationships in time between vaginal colonization with a UTI-causing bacteriuria, asymptomatic bacteriuria, and symptomatic UTI and the presence of persistent bacteria in the bladder following the symptomatic UTI at entry into the study. They will also investigate if such bacteria are related to later UTIs that are caused by the same bacteria that caused the UTI at entry into the study. This will enable them to determine the relative importance of vaginal colonization vs. persistent infection of the bladder as the origin of the bacteria causing recurrent UTI. UTI-causing bacteria cultured from women with symptomatic UTI and asymptomatic bacteriuria will undergo studies at Washington University in Seattle to identify unique genes that may help understanding of why some bacteria cause symptoms and others do not. The effect of bacteria causing UTI in these women on host response will be determined by different studies conducted at Washington University. The researchers plan to enroll 200 women, aged 18–49 years, with a history of at least one previous UTI during the prior 12 months. Women must not be pregnant or planning to become pregnant.
Pelvic Pain in Women with Endometriosis
The Eunice Kennedy Shriver National Institute of Child Health and Human Development is sponsoring a study that will examine pelvic pain associated with endometriosis and explore better approaches to treatment. Researchers will investigate the role of sex hormones, immune chemicals, stress hormones, and genes in pelvic pain and determine how the nerve, muscle, and skeletal systems are involved in this pain. The team plans to enroll women between ages 18 and 50 years with endometriosis and chronic pelvic pain, chronic pelvic pain but no endometriosis, and a healthy volunteer cohort willing to have a laparoscopy to perform a tubal ligation. Participants with chronic pain will receive a laparoscopy to look for and remove endometrial tissue. Follow-up visits are then scheduled at 1, 3, and 6 months after surgery to complete questionnaires and determine if the treatment is working.