ACTIVISM

We are dedicated to the fusion of consciousness-raising, activism, scholarship, and feminist politics. Working both within and outside of academia, we work to lessen gender inequalities and place menstruation and women’s reproductive health in the spotlight.

Our actions include a congressional bill that addresses the potential dangers of using tampons, position statements regarding issues such as continuous oral contraceptive use, Menstrual Hygiene Day, student activism to lessen shame and secrecy surrounding menstruation, working to revise the language of “Premenstrual Dysphoric Disorder,” and better recognition of women’s reproductive health and its links to social justice in the U.S. and globally.

ACTIVIST ENGAGEMENT

New View Campaign - Oct 2016

October, 2016: Critique-Resist- Transform: Feminist Scholar Activism and the New View Campaign

Several members of the Society for Menstrual Cycle Research will attend this event to present work on the medicalization of sex and menstruation.

More information can be found at the New View website.

Selling Sickness: People before Profits in Washington, DC

Seven members of the Society for Menstrual Cycle Research presented a symposium titled The Medicalization of the Menstrual Cycle. Panelists addressed the menstrual cycle throughout the life cycle, from menarche to menopause, as well as menstrual activism and media representations of menstruation.

PDF

Robin Danielson Act

Robin Danielson Act Introduced on Menstrual Hygiene Day

Communities around the world marked the first Menstrual Hygiene Day on May 28, 2014, to break the silence and build awareness about the fundamental role that good menstrual hygiene management (MHM) plays in enabling women and girls to reach their full potential.Representative Carolyn Maloney of New York’s 12th District chose this as the ideal day to introduce an updated version of the Robin Danielson Bill, legislation to study the health effects of menstrual hygiene products. The Robin Danielson Act of 2014 would require the National Institutes of Health (NIH) to research whether menstrual hygiene products that contain dioxin, synthetic fibers, and other chemical additives like chlorine and fragrances, pose health risks. SMCR is among many organizations endorsing this bill. We urge you to contact your representative and encourage them to support the Robin Danielson Act of 2014.

Testimony to Office of Research on Women’s Health at NIH, Chicago - October 2009

Society for Menstrual Cycle Research Priorities for Women’s Health Research

Prepared Testimony to Office of Research on Women’s Health at NIH, Chicago – October 4, 2009

This document is also available as a PDF.

I. Preface: The Society for Menstrual Cycle Research

Founded in 1979, the Society for Menstrual Cycle Research (SMCR) is a nonprofit, interdisciplinary research organization whose members have made significant contributions to menstruation research. We strive to be the source of guidance, expertise, and ethical considerations for researchers, practitioners, policy makers, and funding resources interested in the menstrual cycle. Our membership spans discipline, professional responsibilities, and geography to provide woman-centered perspectives on menstrual experiences. The purposes of the Society are to identify research priorities, to recommend research strategies, and to promote interdisciplinary woman-centered research on the menstrual cycle; to provide a formal communication network to facilitate interdisciplinary dialogue about menstrual cycle research in the context of women’s health over the life span; to examine the practical, ethical, and policy issues surrounding menstrual cycle research; to generate and exchange information and to promote public discussion of issues related to the menstrual cycle; and to influence public policy for the enhancement of women’s health.

We endorse the four overarching themes identified by NIH in 2009 for addressing research on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and Diversity, and Interdisciplinary Research. In SMCR, we are particularly aware of the stigma and silence surrounding menstruation and reproductive health issues. We believe that context, wellness, and prevention must be highlighted when priorities for women’s health are discussed and established in order to develop effective and realistic health strategies.

II. SMCR Recommendations for Research Priorities

Medical research on sex hormones must be seen in terms of women’s health, rather than disease. Menopause is not a disease of estrogen deficiency but a normal phase of an adult woman’s life, nor is menstruation a disease requiring medication or other treatment.

A. Menopause and Estrogen Therapy (1)

The Women’s Health Initiative (WHI) research provided strong evidence that hormone therapies are not safe and effective for prevention of chronic illness, and that menopause is not an estrogen deficiency disease. Prior to WHI, many in the medical community had advocated use of hormones for disease prevention notwithstanding a lack of experimental data pertaining to this, based on weaker kinds of evidence and their professional judgment. WHI provided strong clinical trial evidence, using the hormones that were most commonly prescribed in the US at the time of the study, that neither estrogen alone nor in combination with a progestin prevents heart disease, and, in addition, when several outcomes were considered together, overall harm outweighed overall benefit. The conviction that hormones prevent disease relied on the idea that menopause is a disease state, in which estrogen deficiency creates vulnerability to a wide range of illnesses, including heart, bone, and brain disease. The WHI results therefore also supported SMCR’s position that menopause is a normal phase of a woman’s life and not an estrogen deficiency disease that requires so-called hormone replacement to prevent serious chronic illnesses.

A criticism of WHI that has been given great credence is the “timing hypothesis”, which asserts that significant disease prevention was not observed in this study because the participants were too old. In this view, hormone therapy must be begun soon after menopause (or even in perimenopause) in order to be effective for disease prevention; if women begin hormone therapy many years after menopause, it is believed to be already too late to be helpful and, because of incipient development of disease, can be actually harmful. This idea is being generalized to a variety of chronic illnesses of old age, including heart and brain disease.

SMCR regards the credence given this emerging estrogen “timing hypothesis” with alarm. Some professional groups have already incorporated this possibility into their recommendations (for example, the North American Menopause Society) and many professional articles reference it. Yet the research supporting the hypothesis is not strong data, and often is not even acceptable as reliable data, when considered by the normal standards used by researchers. For example, conclusions are drawn from data that are not statistically significant or from research that is underpowered. Conclusions are drawn from markers of disease rather than from disease outcomes. Research data inconsistent with the hypothesis are not considered, for example, studies suggesting that younger women also have negative health effects from hormones. Data are inaccurately over-interpreted; for example, assuming that an observation in younger women will continue to be found as they age. Conclusions are drawn based on possible positive coronary artery outcomes while not simultaneously taking into account negative cardiovascular effects such as stroke and serious blood clots. Data on possible other negative outcomes like breast cancer are not given great credence. Further, the WHI study participants in fact reflected the demographic of hormone users when the study was started.

Ironically, WHI showed that a set of hypotheses based on weak data, no matter how firmly believed, can turn out to be inaccurate when clinical trial data are collected. We believe that this lesson of WHI should be remembered. The continued belief in the underlying idea that menopause is an estrogen-deficiency disease, rather than strong evidence, that has led to the hypothesis that hormone therapy immediately after menopause will prevent a broad variety of diseases.

This shows that more work on the natural history of menstruation, ovulation, and changes throughout the menopause transition is needed; such research must be conducted in a population-based contexts. Understanding the natural history of menopausal symptoms requires long-term data on numerous women from diverse backgrounds. In addition, research on medications that could be prescribed to large numbers of otherwise healthy women must use randomized, placebo-controlled trials.

SMCR advocates that avoiding harm should be a primary consideration in preventive health care and in research on preventive health. Even if it were true that hormone therapy could prevent heart and other chronic diseases, a prevention tool that requires medicating large numbers of women for long periods of time relative to the number of women who will benefit, is not effective prevention. This is especially true if the medication in question carries risks of serious outcomes like strokes and blood clots. While risks are not large enough to preclude treating symptomatic women, these medications are inappropriate in a prevention tool. Further, research on EPT and ET for menopausal women has repeatedly caused harm to study participants, in WHI and in previous studies.

A 2005 NIH State-of-the-Science conference recommended that menopause be de-medicalized. The conference statement read,

Menopause is “medicalized” in contemporary U.S. society. There is great need to develop and disseminate information that emphasizes menopause as a normal, healthy phase of women’s lives and promotes its demedicalization. Medical care and future clinical trials are best focused on women with the most severe and prolonged symptoms. (2)

The statement also asserted that much more research is needed to clearly define the natural history of menopause, associated symptoms, and effectiveness and safety of treatments for bothersome symptoms. Natural histories are important for both science and policy. Knowing how many women transit menopause with few or no symptoms, and how many manage menopause largely on their own, can lead to public health information that empowers women and increases their self-reliance.

We endorse these recommendations and believe they are crucial in studying the relationship of hormones and health. We also believe that menopause and aging need to be divorced in order to develop effective strategies for disease prevention and treatment, with continued research on lifestyle and other interventions.

B. Cycle-stopping Contraceptives (3)

It is the position of the Society that menstruation is not a disease, and that further research on the potential health risks and long-term safety of cycle-stopping contraception is needed. While some research exists on endometrial safety and on patterns of unexpected and expected bleeding, long-term studies that address potential risks beyond the uterus, such as breast, bone, and cardiovascular health are still needed. Furthermore, there is an urgent need for studies that address impacts on adolescent development and bone density over time, since young women and girls are a target market for cycle-stopping contraceptives.

It is important to note that cycle-stopping contraceptives do not only reduce or eliminate menstrual bleeding, but also suppress the complex hormonal interplay of the menstrual cycle. The impacts of this cycle on women’s health are not completely understood.

It is also critical to address the social, psychological, and cultural implications of menstrual suppression, as well as the biomedical effects. We remain concerned that campaigns used to market cycle-stopping contraception depict the menstrual cycle as abnormal, undesirable, unnecessary and even unhealthy. Messages that women’s natural functions are defective or need to be medically controlled can lead to negative body image, especially in young women.

Arguments for cycle-stopping contraception often describe debilitating menstrual cramps and heavy flow as indications, but promote routine use by all women who would prefer not to menstruate for matters of convenience. Cycle-stopping contraception may be useful for some medical conditions (such as severe endometriosis), but we caution against its use as “a lifestyle choice” until safety is firmly established. Although women in the US have been using oral contraceptives for nearly 50 years with no large-scale disasters, there is no precedent for continuous use of such large doses of hormones from the teen years to menopause. Women currently use oral contraceptives from their teens until their late twenties or early thirties, when they typically complete their families, and then they choose a more permanent method of contraception (either tubal ligation or vasectomy for their male partners).

Hormonal contraception is a valid and appropriate choice for many women. But historically, nasty surprises with hormonal therapies for women (e.g., heart disease and hormone therapy for menopausal women, the link between oral contraceptives and blood clots, DES and multiple health problems) have taken many years to surface. We note that Lybrel, Seasonale, and other contraceptives marketed for their cycle-stopping properties underwent clinical testing for only one year. Additionally, when any medication is evaluated for healthy women, the potential risks should be weighed more heavily than in situations when medication is considered to treat a disease. Menstruation is not a disease.

Some have claimed that women should be “free” to choose cycle stopping contraception. However, informed choices are only possible when reliable, accurate, and comprehensive information is widely available.

III. Conclusions

We appreciate the opportunity to present our positions on women’s health research to the ORWH at NIH. As indicated above, we endorse the four overarching themes identified by NIH in 2009 for addressing research on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and Diversity, and Interdisciplinary Research. Medical research on sex hormones must be seen in terms of women’s health, rather than disease. Future NIH research on women’s health must include increased attention to prevention and wellness, and be appropriately situated in the diverse social and cultural contexts of women’s lives and women’s bodies. We in SMCR are keenly aware of the stigma and silence surrounding menstruation and related health issues, and concerned about the implications of such taboo for women’s access to accurate medical knowledge and health care.

Ultimately the evaluation of and recommendations for women’s health must be made on rigorous scientific standards, incorporate prevention and wellness along with diagnosis and treatment, and reject underlying or explicit assumptions that menstruation and menopause are diseases or deficiencies.

(1) Adapted from October, 2007: Women’s Health Initiative & Estrogen Therapy, online at http://menstruationresearch.org/position-statements/position-statement/womens-health-initative-ht-updated-2007/, accessed September 18, 2009.

(2) NIH State-of-the-Science Conference Statement on Management of Menopause-Related Symptoms, 2005, online at http://consensus.nih.gov/2005/2005MenopausalSymptomsSOS025html.htm, accessed September 26, 2009.

(3) Adapted from June, 2007 (SMCR Meeting, Vancouver): Menstrual Suppression, online at http://menstruationresearch.org/position-statements/position-statement/menstrual-supression-2007/, accessed September 18, 2009.

Prepared by Elizabeth A. Kissling, Ph.D., President, for the Society for Menstrual Cycle Research

POSITION STATEMENTS

June 2015: SMCR Objects to FDA Approval of Flibanserin

The Society for Menstrual Cycle Research regrets the recommendation by the Bone, Reproductive, and Urologic Advisory Committee and the Drug Safety and Risk Management Advisory Committee on June 4, 2015 that flibanserin be approved with risk management options.

View formal document here (PDF)

October 2009: Testimony to Office of Research on Women’s Health at NIH, Chicago

Medical research on sex hormones must be seen in terms of women’s health, rather than disease. Menopause is not a disease of estrogen deficiency but a normal phase of an adult woman’s life, nor is menstruation a disease requiring medication or other treatment.

View formal document here (PDF)

June 2007: SMCR Meeting, Vancouver (Menstrual Suppression)

At the 2007 meetings of the Society for Menstrual Cycle Research, members discussed current consumer and medical interest in extended hormonal contraceptives to reduce or eliminate menstruation (cycle-stopping contraception). A number of research papers on this topic were presented. It is the position of the Society that menstruation is not a disease, and that further research on the potential health risks and long-term safety of cycle-stopping contraception is still needed.

View formal document (PDF)

October 2002 (Revised June 2003): Women’s Health Initiative Estrogen Plus Progestin Arm

SMCR issued an official position statement affirming that the WHI Estrogen plus Progestin trial has produced Level 1 evidence that was previously unavailable. These data strongly support SMCR’s position that menopause is a normal phase of all women’s lives and not an estrogen deficiency state that requires hormone “replacement” to prevent serious chronic diseases. Furthermore, integration of previous epidemiological data on menopausal women’s risks for cardiovascular disease with the new WHI data suggests that 59-79% of women’s risks for heart attack and stroke can be eliminated by positive lifestyles and socioeconomic biases in the observational studies. The Society also stated that more research is needed prospectively documenting women’s health and experiences through the menopause transition (perimenopause) in multicultural populations and more research is also needed into the etiology and management of hot flashes/night sweats and other changes that are distressing for some women during the menopause transition and following menopause.

June 2001: Premenstrual Dysphoric Disorder (PMDD) and Sarafem

SMCR called upon the FDA to to reconsider its approval of Sarafem for the treatment of “Premenstrual Dysphoric Disorder”.

April 2012: Naming Women’s Midlife Reproductive Transition

In the interest of reducing confusion and improving midlife women’s quality of life, as well as access, if desired or needed, to appropriate health care, and promoting the use of clearer terminology, we recommend specific and precise use of the terms of perimenopause and menopause.

View formal document (PDF)

October 2007: Women’s Health Initiative & Estrogen Therapy

In Spring, 2007, the Board of Directors of the Society for Menstrual Cycle Research decided to update the Society’s 2003 position statement, “Women’s Health Initiative & HRT.” The basic conclusions of the Society’s 2003 position statement remain: WHI provided strong evidence that hormone therapies are not safe and effective for prevention of chronic illness, and that menopause is not an estrogen deficiency disease. However, this updated statement adds a critique of an increasingly heard criticism, the “timing hypothesis,” which asserts that the WHI research results are limited to older postmenopausal women and that younger women would derive positive benefits from hormone use. This hypothesis has little experimental confirmation and should not be the basis for professional decision-making.

June 2003: SMCR Meeting, Pittsburgh (Menstrual Suppression)

Based on research presented at the 2003 meeting, the Society issued a statement recognizing that menstrual suppression may be a useful option for women with severe menstrual cycle problems such as endometriosis, but recommending that continuous oral contraceptive use should NOT be prescribed to all menstruating women out of a rejection of a normal, healthy menstrual cycle. The statement recommended more research is needed before women can make informed decisions.

June 2001: Women’s Health Initiative & Hormone Replacement Therapy

The Society adopted a resolution urging that menopausal treatment with estrogen and progestin or progesterone be called “Ovarian Hormone Therapy” (OHT) instead of “Hormone Replacement Therapy” (HRT).

Approved by vote of the membership at the business meeting held on June 8, 2001 during the 14th Conference of the Society for Menstrual Cycle Research in Avon, Connecticut

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