women’s health
Expanding Menopause Research to Advance the Health of All Women
Posted on by Janine Austin Clayton, M.D., FARVO, NIH Office of Research on Women’s Health
Since 2017, NIH’s Office of Research on Women’s Health (ORWH) has hosted the Vivian W. Pinn Symposium during National Women’s Health Week (NWHW) in May. This event honors the first full-time director of the office, Dr. Vivian W. Pinn, and serves as a critical forum for experts across sectors to communicate and collaborate for the advancement of women’s health.
This week marks the beginning of the 2023 NWHW, and on May 16, ORWH will host the 7th Annual Vivian W. Pinn Symposium. It’s titled: Menopause and Optimizing Midlife Health of Women.
Topics to be discussed include: the menopausal transition (also known as perimenopause), the accumulation of morbidity after menopause, menopause in special populations, the influence of social determinants of health on the experience of menopause, the use of menopausal hormone therapy (MHT), and interventions to promote healthy aging.
This year, JoAnn Manson, Harvard Medical School, Cambridge, MA, will deliver the keynote speech, titled “Menopausal Hormone Therapy: 30 Years of Lessons from the Women’s Health Initiative.” I encourage everyone with an interest in women’s health to register for the event.
In 1992, NIH’s National Heart, Lung, and Blood Institute launched the Women’s Health Initiative (WHI), seeking to improve the health of women through research on prevention of serious health conditions in postmenopausal women. Over three decades later, WHI remains an extraordinary example of centering research around the health needs of women, and WHI research results “definitively established that menopausal hormone therapy should not be used to prevent heart disease, stroke, and other chronic diseases.” These results were practice-changing and led to a dramatic decline in the use of MHT.
Menopause is a natural and irreversible life course stage marked by the cessation of menstrual cycling for 12 consecutive months. Common symptoms associated with menopause include hot flashes, sleep disturbances, mood changes, headaches, and heart palpitations. An article, co-authored by Dr. Manson, summarizes effective hormonal and non-hormonal treatments to manage menopausal symptoms [1].
The WHI’s longer-term follow-up of the treatment of these women, however, has demonstrated many nuanced findings [2]. For example, MHT’s risks and benefits are complex and vary based upon patient-level characteristics, including the age at which the therapy is initiated and the formulation of the MHT prescribed. Importantly, WHI was designed to assess the efficacy of MHT in preventing chronic disease, not to assess the efficacy or safety of MHT when used to treat menopausal symptoms. The average study participant was older, with over a decade since the start of their menopausal transition.
When considering any treatment, people should consult a health care professional, and MHT may be an option for some women, especially those who are experiencing menopausal symptoms and are at low risk for adverse events. The Food and Drug Administration (FDA) offers a fact sheet to answer questions and provide guidance about menopause and hormones, and has evaluated the risks and benefits of MHT for specific age groups of women [3].
In addition to WHI, there are two other valuable NIH-funded studies helping to make progress in our understanding of the health of midlife and older women:
• Study of Women’s Health Across the Nation (SWAN)
• Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH)
A major health concern for women during perimenopause, menopause, and post menopause is cardiovascular health. More research is needed to understand how different stages of menopause affect women’s cardiovascular health and how different doses and formulations of MHT may affect risk.
Among the many speakers at the Vivian W. Pinn Symposium will be Wendy Kohrt, a co-author on a recent comprehensive review of cardiovascular health and menopause [4]. She is director of the University of Colorado Specialized Centers of Research Excellence on Sex Differences (SCORE), Aurora. Also, a recent issue of ORWH’s Women’s Health in Focus at NIH discussed current NIH-funded research on menopause, resources, future menopause-related research, and more.
In response to a Congressional request to address NIH efforts related to women’s health research, ORWH hosted, along with the NIH Advisory Committee on Research on Women’s Health, “Advancing NIH Research on the Health of Women: A 2021 Conference.” The importance of menopause research as it relates to chronic debilitating conditions, which pose a significant burden on the health of women, was addressed during the conference, and the full report is available on the ORWH website.
Further, ORWH and partnering institutes released two notices of funding opportunities titled Understanding Chronic Conditions Understudied Among Women (R01 and R21), and ORWH sponsored the forthcoming Framework for the Consideration of Chronic Debilitating Conditions in Women from the National Academies of Sciences, Engineering, and Medicine.
I wish everyone a happy and healthy NWHW and look forward to gathering virtually for the 7th Annual Vivian W. Pinn Symposium. For more information and resources on menopause, visit the FDA’s Office of Women’s Health and NIH’s National Institute on Aging (NIA) websites. Also, My Menoplan, developed by NIA-funded researchers, offers information and personalized tools to help plan for perimenopause and menopause. Please stay connected to ORWH by visiting our website for updates; signing up for our monthly newsletter, The Pulse; liking us on Facebook; and following ORWH on Twitter.
References:
[1] Management of menopausal symptoms: A review. Crandall CJ, et al. JAMA. 2023 February 7: 329(5):405-420.
[2] Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. Manson JE, et al. JAMA. 2013 October 2: 310(13)1353-1368.
[3] Randomized trial evaluation of the benefits and risks of menopausal hormone therapy among women 50-59 years of age. Prentice RL, et al. Am J Epidemiol. 2021 February 1: 190(3):365-375.
[4] Body composition and cardiometabolic health across the menopause transition. Marlatt KL, et al. Obesity. 2022 January; 30(1)14-27.
Links:
Office of Research on Women’s Health (NIH)
7th Annual Vivian W. Pinn Symposium (ORWH)
Specialized Centers of Research Excellence on Sex Differences (SCORE) (ORWH)
National Women’s Health Week (Office on Women’s Health, U.S. Department of Health and Human Services, Rockville, MD)
Women’s Health Initiative (WHI)
Study of Women’s Health Across the Nation (SWAN)
Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) (Fred Hutchinson Cancer Center, Seattle)
Office of Women’s Health (U.S. Food and Drug Administration, Silver Spring, MD)
Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes, Centers, and Offices to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 30th in the series of NIH guest posts that will run until a new permanent NIH director is in place.
Studies Confirm COVID-19 mRNA Vaccines Safe, Effective for Pregnant Women
Posted on by Dr. Francis Collins
Clinical trials have shown that COVID-19 vaccines are remarkably effective in protecting those age 12 and up against infection by the coronavirus SARS-CoV-2. The expectation was that they would work just as well to protect pregnant women. But because pregnant women were excluded from the initial clinical trials, hard data on their safety and efficacy in this important group has been limited.
So, I’m pleased to report results from two new studies showing that the two COVID-19 mRNA vaccines now available in the United States appear to be completely safe for pregnant women. The women had good responses to the vaccines, producing needed levels of neutralizing antibodies and immune cells known as memory T cells, which may offer more lasting protection. The research also indicates that the vaccines might offer protection to infants born to vaccinated mothers.
In one study, published in JAMA [1], an NIH-supported team led by Dan Barouch, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, wanted to learn whether vaccines would protect mother and baby. To find out, they enrolled 103 women, aged 18 to 45, who chose to get either the Pfizer/BioNTech or Moderna mRNA vaccines from December 2020 through March 2021.
The sample included 30 pregnant women,16 women who were breastfeeding, and 57 women who were neither pregnant nor breastfeeding. Pregnant women in the study got their first dose of vaccine during any trimester, although most got their shots in the second or third trimester. Overall, the vaccine was well tolerated, although some women in each group developed a transient fever after the second vaccine dose, a common side effect in all groups that have been studied.
After vaccination, women in all groups produced antibodies against SARS-CoV-2. Importantly, those antibodies neutralized SARS-CoV-2 variants of concern. The researchers also found those antibodies in infant cord blood and breast milk, suggesting that they were passed on to afford some protection to infants early in life.
The other NIH-supported study, published in the journal Obstetrics & Gynecology, was conducted by a team led by Jeffery Goldstein, Northwestern’s Feinberg School of Medicine, Chicago [2]. To explore any possible safety concerns for pregnant women, the team took a first look for any negative effects of vaccination on the placenta, the vital organ that sustains the fetus during gestation.
The researchers detected no signs that the vaccines led to any unexpected damage to the placenta in this study, which included 84 women who received COVID-19 mRNA vaccines during pregnancy, most in the third trimester. As in the other study, the team found that vaccinated pregnant women showed a robust response to the vaccine, producing needed levels of neutralizing antibodies.
Overall, both studies show that COVID-19 mRNA vaccines are safe and effective in pregnancy, with the potential to benefit both mother and baby. Pregnant women also are more likely than women who aren’t pregnant to become severely ill should they become infected with this devastating coronavirus [3]. While pregnant women are urged to consult with their obstetrician about vaccination, growing evidence suggests that the best way for women during pregnancy or while breastfeeding to protect themselves and their families against COVID-19 is to roll up their sleeves and get either one of the mRNA vaccines now authorized for emergency use.
References:
[1] Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women. Collier AY, McMahan K, Yu J, Tostanoski LH, Aguayo R, Ansel J, Chandrashekar A, Patel S, Apraku Bondzie E, Sellers D, Barrett J, Sanborn O, Wan H, Chang A, Anioke T, Nkolola J, Bradshaw C, Jacob-Dolan C, Feldman J, Gebre M, Borducchi EN, Liu J, Schmidt AG, Suscovich T, Linde C, Alter G, Hacker MR, Barouch DH. JAMA. 2021 May 13.
[2] Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in pregnancy: Measures of immunity and placental histopathology. Shanes ED, Otero S, Mithal LB, Mupanomunda CA, Miller ES, Goldstein JA. Obstet Gynecol. 2021 May 11.
[3] COVID-19 vaccines while pregnant or breastfeeding. Centers for Disease Control and Prevention.
Links:
COVID-19 Research (NIH)
Barouch Laboratory (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston)
Jeffery Goldstein (Northwestern University Feinberg School of Medicine, Chicago)
NIH Support: National Institute of Allergy and Infectious Diseases; National Cancer Institute, National Institute of Child Health and Human Development; National Center for Advancing Translational Sciences; National Institute of Biomedical Imaging and Bioengineering
Insurance Status Helps Explain Racial Disparities in Cancer Diagnosis
Posted on by Dr. Francis Collins
Women have the best odds of surviving breast cancer if their disease is caught at an early stage, when treatments are most likely to succeed. Major strides have been made in the early detection of breast cancer in recent years. But not all populations have benefited equally, with racial and ethnic minorities still more likely to be diagnosed with later-stage breast cancer than non-Hispanic whites. Given that recent observance of Martin Luther King Day, I thought that it would be particularly appropriate to address a leading example of health disparities.
A new NIH-funded study of more than 175,000 U.S. women diagnosed with breast cancer from 2010-2016 has found that nearly half of the troubling disparity in breast cancer detection can be traced to lack of adequate health insurance. The findings suggest that improving insurance coverage may help to increase early detection and thereby reduce the disproportionate number of breast cancer deaths among minority women.
Naomi Ko, Boston University School of Medicine, has had a long interest in understanding the cancer disparities she witnesses first-hand in her work as a medical oncologist. For the study published in JAMA Oncology, she teamed up with epidemiologist Gregory Calip, University of Illinois Cancer Center, Chicago [1]. Their goal was to get beyond documenting disparities in breast cancer and take advantage of available data to begin to get at why such disparities exist and what to do about them.
Disparities in breast cancer outcomes surely stem from a complicated mix of factors, including socioeconomic factors, culture, diet, stress, environment, and biology. Ko and Calip focused their attention on insurance, thinking of it as a factor that society can collectively modify.
Many earlier studies had shown a link between insurance and cancer outcomes [2]. It also stood to reason that broad differences among racial and ethnic minorities in their access to adequate insurance might drive some of the observed cancer disparities. But, Ko and Calip asked, just how big a factor was it?
To find out, they looked to the NIH’s Surveillance Epidemiology, and End Results (SEER) Program, run by the National Cancer Institute. The SEER Program is an authoritative source of information on cancer incidence and survival in the United States.
The researchers focused their attention on 177,075 women of various races and ethnicities, ages 40 to 64. All had been diagnosed with invasive stage I to III breast cancer between 2010 and 2016.
The researchers found that a higher proportion of women receiving Medicaid or who were uninsured received a diagnosis of advanced stage III breast cancer compared with women with health insurance. Black, American Indian, Alaskan Native, and Hispanic women also had higher odds of receiving a late-stage diagnosis.
Overall, their sophisticated statistical analyses traced up to 47 percent of the racial/ethnic differences in the risk of locally advanced disease to differences in health insurance. Such late-stage diagnoses and the more extensive treatment regimens that go with them are clearly devastating for women with breast cancer and their families. But, the researchers note, they’re also costly for society, due to lost productivity and escalating treatment costs by stage of breast cancer.
These researchers surely aren’t alone in recognizing the benefit of early detection. Last week, an independent panel convened by NIH called for enhanced research to assess and explore how to reduce health disparities that lead to unequal access to health care and clinical services that help prevent disease.
References:
[1] Association of Insurance Status and Racial Disparities With the Detection of Early-Stage Breast Cancer. Ko NY, Hong S, Winn RA, Calip GS. JAMA Oncol. 2020 Jan 9.
[2] The relation between health insurance coverage and clinical outcomes among women with breast cancer. Ayanian JZ, Kohler BA, Abe T, Epstein AM. N Engl J Med. 1993 Jul 29;329(5):326-31.
[3] Cancer Stat Facts: Female Breast Cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program.
Links:
Cancer Disparities (National Cancer Institute/NIH)
Breast Cancer (National Cancer Institute/NIH)
Naomi Ko (Boston University)
Gregory Calip (University of Illinois Cancer Center, Chicago)
NIH Support: National Center for Advancing Translational Sciences; National Cancer Institute; National Institute on Minority Health and Health Disparities
Black Maternal Health Caucus Roundtable
Posted on by Dr. Francis Collins
Talking With Barbra Streisand
Posted on by Dr. Francis Collins
Barbra Streisand came to NIH on May 15, 2018 to deliver the annual J. Edward Rall Cultural Lecture. I got to sit down with her as the lecture moderator and discuss women’s heart health as well as the tremendous importance of including women in research studies.
Preeclampsia: Study Highlights Need for More Effective Treatment, Prevention
Posted on by Dr. Francis Collins
Thinkstock
It’s well known that preeclampsia, a condition characterized by a progressive rise in a pregnant woman’s blood pressure and appearance of protein in the urine, can have negative, even life-threatening impacts on the health of both mother and baby. Now, NIH-funded researchers have documented that preeclampsia is also taking a very high toll on our nation’s economic well-being. In fact, their calculations show that, in 2012 alone, preeclampsia-related care cost the U.S. health care system more than $2 billion.
These findings are especially noteworthy because preeclampsia rates in the United States have been steadily rising over the past 30 years, fueled in part by increases in average maternal age and weight. This highlights the urgent need for more research to develop new and more effective strategies to protect the health of all mothers and their babies.
Snapshots of Life: Fighting Urinary Tract Infections
Posted on by Dr. Francis Collins
Source: Valerie O’Brien, Matthew Joens, Scott J. Hultgren, James A.J. Fitzpatrick, Washington University, St. Louis
For patients who’ve succeeded in knocking out a bad urinary tract infection (UTI) with antibiotic treatment, it’s frustrating to have that uncomfortable burning sensation flare back up. Researchers are hopeful that this striking work of science and art can help them better understand why severe UTIs leave people at greater risk of subsequent infection, as well as find ways to stop the vicious cycle.
Here you see the bladder (blue) of a laboratory mouse that was re-infected 24 hours earlier with the bacterium Escherichia coli (pink), a common cause of UTIs. White blood cells (yellow) reach out with what appear to be stringy extracellular traps to immobilize and kill the bacteria.
Morning Sickness Associated with Lower Miscarriage Risk
Posted on by Dr. Francis Collins
Thinkstock
During the first trimester of pregnancy, many women experience what’s commonly known as “morning sickness.” As distressing as this nausea and vomiting can be, a team of NIH researchers has gathered some of the most convincing evidence to date that such symptoms may actually be a sign of something very positive: a lower risk of miscarriage.
In fact, when the researchers studied a group of women who had suffered one or two previous miscarriages, they found that the women who felt nauseous during their subsequent pregnancies were 50 to 75 percent less likely to miscarry than those without nausea. While it’s not yet exactly clear what’s going on, the findings lend support to the notion that morning sickness may arise from key biological factors that reflect an increased likelihood of a successful pregnancy.
