Dr. Nancy Reame, Mary Dickey Lindsay Professor Emerita of Disease Prevention and Health Promotion at Columbia University’s School of Nursing, has been an active women’s health advocate, clinician, and researcher focusing on menstruation and menopause for several decades and for many years was a contributor to the iconic women’s health book, Our Bodies, Ourselves.
Dr. Reame’s newly published commentary in Women’s Reproductive Health reflects on the history, achievements, challenges, and current implications of menstrual-related Toxic Shock Syndrome (mTSS) and broader health implications. Please see citation below for full publication details.
Nancy King Reame (2018) The Legacy of Tampon-Related Toxic Shock Syndrome: Feats, Failures, and Future Challenges for Women’s Health Scholars, Women’s Reproductive Health, 5:4, 250-261, DOI: 10.1080/23293691.2018.1523118
Blog post contributed by Research Fellow Adrienne Pichon.
In this new article and at the “Menstruation is having its Moment” panel, you talked about a “tipping point” in the “movement” rather than a “moment”. Could you talk about what you have witnessed first-hand with this shift in mindset and ways academic researchers and activists can embrace it to “make menstruation matter” more broadly?
Trying to do research on menstruation back in the day was nearly impossible! The first “menstrual moment”, which really started the menstrual health movement 40 years ago, was in response to the mTSS epidemic (menstrual-related toxic shock syndrome). Young girls and women were dying and we didn’t know why! Once the connection between tampons and mTSS was discovered, it became clear not only to the FDA, but also to the tampon producers there was a huge gap in our understanding about how menstrual blood interacted with the vaginal environment and, in turn, degraded during the use of what were termed “feminine hygiene” products. I was at the right place at the right time, as most of academic medicine was not keen to be involved in research on menstruation, and just having graduated with a PhD in reproductive physiology and a background in OB nursing. I received a small grant from Kimberly Clarke, a tampon producer, to analyze the composition of menstrual fluid. (At the time, the industry standard was blue-dyed saline, referred to as “blue goo” by the all-male, paper chemists in R&D). So I recruited labor and delivery nurses to collect their own menstrual blood using a menstrual cup, which seemed totally reasonable and natural for us as women and nurses, and borrowed a paint viscosity machine from a physics lab down the hall to assess viscosity as well as other properties. That same year, the FDA task force was convened, and I served as the testing lab for the consumer advocates on the committee. We used outdated heparinized blood from the hospital blood bank and compared tampon absorbency to the standard test fluid (blue-dyed saline) in a testing device used by the FDA and the tampon producers called a “syngyna”. We named ours “Sally”! All along the way, I was told by the tampon industry reps that it wouldn’t work – that the blood was too viscous and would clog up the machine – but it did! These data demonstrated marked differences in tampon absorbency across brands and absorbency categories which ultimately helped support the change in tampon absorbency labeling on all products, still in effect today.
Despite this policy breakthrough in response to the TSS “epidemic” in the 1980’s, not much has happened since then in terms of product testing and safety until now, with this groundswell of interest and willingness to tackle on the part of consumers and activists because many of the same issues persist. This is what I’m talking about with a “tipping point”; I’m optimistic. In fact, the NIH held a “Menstruation: Science and Society” meeting in September 2018, which is HUGE! The government and academic science now seem to be “backing in” to the movement started at the grassroots level. It really did have to become a “public issue” with a sense that women see this as a highly important public health need to be brought to the attention of the government, and it certainly wasn’t going to be coming from the tampon producers. But even they are getting on board, too – recognizing the value of “Femtech”, giving information via websites and blogs, promoting diversity in their advertising, and co-sponsoring menstrual health initiatives – of course with self-serving reasons.
Back in the 20th century, we had a small group of mostly women researchers from the Society for Menstrual Research (SMR) who were the only thought leaders interested in menstruation, and were isolated and marginalized. Now, women in science are finally coming into our own. With more women in science and industry, the landscape is changing as a culmination of all of these social and economic forces. The powerful grassroots and global public health advocates have brought attention to this issue. Academics and federal research enterprise have been the last groups to the table, which is interesting. Bringing different disciplines together with health activists and public health advocates for mutually beneficial collaboration is an enormous revolution in science.
To address current research gaps, you emphasize the value of multidisciplinary research teams. Why is this such a strength and what are some ways we can leverage the interdisciplinary nature of the MHGJ Working Group to continue advancing this movement?
The advances in science and complex questions require expertise in different domains/methods to address not only the breadth and scope of contemporary social problems but also the depth. As a clinical researcher who is most interested in precision, there is tremendous strength to including epidemiologists and bio-informaticians in my work. For example, my mechanistic research has always focused on capturing highly detailed data from small well-characterized homogeneous samples, but now working with Noemie Elhadad and others from our group, the work is synergistic and compliments the broad approach of epidemiology and big data scientists that are able to capture and harness data from millions of menstruators (acting as citizen scientists) who use mobile apps for menstrual tracking. This multidimensional approach helps to strengthen the precision of the work to advance it with new capabilities.
Thinking of our group, I’ve always been very comfortable working with anthropologists, sociologists, psychologists, and women’s health scholars. Because I’m a nurse-scientist, I was trained to think with a broad perspective, breadth, and scope in addressing research questions. Most nurse researchers are either trained in other disciplines or draw on a wide range of basic and applied sciences that they bring to bear on clinical questions. So for me and within our group, it is natural to borrow from different disciplines and include perspectives from various women’s studies scholars, legal scholars, ethicists, psychologists, even around basic science questions because it is so hard to get away from the “human voice” that drives many of the clinical questions we ask.
You mentioned before about “citizen scientists”. How do patients fit within these multidisciplinary teams?
There are now several formal mechanisms funded through the NIH, to recruit patients to be involved in big data science and research. This means patients can participate by providing their own clinical data and tests to be included in a de-identified database repository, to be used to answer broader questions. These programs, based on patient-input, developed thoughtful strategies to protect privacy and other concerns raised by patient groups. More importantly, there is also a cultural shift in the mindset of the government, that patients are partners in research and are now “research participants” and no longer “research subjects”. All of these strategies have moved the focus towards patient or person-centered ways of doing research. It’s no longer enough to send an abstract to a research participant with a list of unintelligible study findings; now community members are being included from the beginning of a project, in the design of studies and thinking through research questions. It’s a much more respectful approach, shifting the attitude towards appreciating patients as willing, important, and valued team partners. That’s an attitude change that can’t be faked, and insincerity is obvious.
You also talk about “expert patients,” yet the safety information on a number of commercial/industry websites is presented under a tab reserved “For Health Care Professionals.” What’s up with this?
I’ve seen this across several medical and pharma websites, for not only drugs but for health care products as well, that gives different levels of information for providers and patients, with more detailed specifics about clinical trial data, for example, included for clinicians but omitted from patient information. This reminds me of back in the day, going back to the first “menstrual moment” when the Boston Women’s Health Book Collective published Our Bodies, Ourselves, which started because women wanted to learn basic health information about their bodies than what they were being told by doctors. They realized they could go to the medical library at Harvard the same way physicians did and read the latest academic literature to get a fairly good understanding of the information they were seeking, and in turn, could help each other.
The idea that patients aren’t able to understand medical content or appreciate problems and risks, is an outdated and patronizing view. I’m not suggesting that that’s the intent of drug companies, but it sure smells that way sometimes. What are we hiding or keeping from patients? Nowadays, people seeking health information often go to very sophisticated websites to look up the latest treatments and interventions. The idea that consumers aren’t sophisticated enough to know where to go (on the internet), including the same websites the physicians are viewing (e.g. New England Journal of Medicine) is quite naïve. On the other hand, much more needs to be done with respect to educating the public regarding which websites to trust for seeking legitimate, non-commercialized, un-biased information. This is probably one of the biggest hazards internet users face today.
You talk about your work in the 1980s towards practical and evidence-based guidelines and regulations around absorbency, test liquid, and labeling of tampons; in the current article, you lay out a clear argument for prioritizing tampon safety, improving and clarifying regulations and guidelines, and promoting research on toxic shock syndrome. Why do you think policy and practice hasn’t implemented evidence-based findings? How can we overcome some of those barriers?
As the lab representative for the consumer advocates on the FDA task force in the 80s, we showed that using blue dyed saline was totally inadequate for testing absorbency of tampons in the laboratory, underestimating absorbency when compared to human de-clotted venous blood… the “blue goo” wasn’t anywhere near the correct consistency! At the same time, to standardize a test that meets FDA requirements and involves millions of tampon products and labs from around the world on a regular basis, using real menstrual blood just isn’t practical! So as a result, this outdated, inadequate testing process has remained the status quo for meeting government regulations. But hopefully things are about to change: renewed support for federal legislation mandating more research, better safety testing procedures, and disclosures of all ingredients may soon see the light of day in Congress. In addition, startup companies are realizing the potential for using menstrual effluent to gain insight into body functions and as a way of collecting cells for genetic testing and diagnosing disease. And devices for collecting and sending menstrual fluid for analysis are being developed and tested, some working in partnership with academic researchers (i.e. NextGen Jane and Dr. Elhadad’s Citizen Endo project).
The problem is, we don’t know what “normal” is yet! We need basic research on the composition and biology of menstrual fluid across a wide range of conditions. Tampon companies have done some of this research as part of their in-house product testing, all of which is proprietary and confidential. They’ve even patented an artificial menses based on uterine blood and mucus obtained from various slaughterhouses, suggesting they appreciate that “blue goo” is insufficient. Given our public comments from years ago with test data clearly indicating that tampons are more absorbent of menstrual effluent compared to saline, it’s not surprising that tampon manufacturers have developed a more realistic appreciation of tampon performance with a more physiologic fluid.
The goal must be to develop a standardized formula for testing menstrual tampons, but roadblocks in funding and political support hinder progress. Public pressure and grassroots efforts built this momentum, but unfortunately, change sometimes only comes after some horrible tragedy and scandal, like the litigation around talc in baby powder and the association with ovarian cancer. Environmental exposures and contaminants, especially when they impact children, pregnant women, or worsen health disparities carry clout and are ammunition for folks to pay attention. But without that pressure, things take a while. Hopefully it won’t take another toxic shock epidemic due to the use of new, hyperabsorbent tampon materials to make this happen.
The time is right to “move” on this. It will be interesting to see, hopefully New York State Congresswoman Carolyn Maloney’s House Bill addressing the tampon tax and funding for menstrual research, testing, and safety will allow us to move forward with earmarked funds! This is the most exciting of all, the tipping point! And now with all of the women in the new Congress, how cool is this and perfect timing!
You mention menstruation as a “vital sign”, which means using menstruation as an indicator for health. How can this be applied to mTSS? Given your menopause expertise, why is it important to consider women’s health and experiences across the lifespan? What do we miss by excluding these women?
Menstruation as a vital sign was only mentioned once at the two-day NIH “Menstruation: Science and Society” meeting, which brought together speakers from different fields and disciplines, so the idea is not being broadly applied or even acknowledged.
Let’s just start by systematically including the menstrual cycle as part of a normal history and physical in primary care, pediatrics, and Emergency Rooms! Menstruation can be an indicator to detect issues with sexual and reproductive health, especially “rare events” like mTSS which has vague symptoms (similar to the flu) and high mortality if not caught early. To find these rare events can have a huge impact. Evaluating menstruation and menstrual cycle features needs to become rote for clinicians – a standard part of any office visit. This single obvious example illustrates how using menstruation as a vital sign could be life-saving. Across the lifespan, common reproductive health issues could be captured much earlier: infertility, endometrial cancer, polycystic ovarian disease, endometriosis, and abnormal bleeding during the peri/post-menopausal years. Even beyond sexual and reproductive health, menstruation can be an important “red flag” (pun intended) for monitoring your health, for example problems with weight and excessive exercise or dieting issues that will turn off the menstrual cycle.
Menopause, or the end of the reproductive lifespan, can be considered an extension of menstruation as a vital sign and has largely been invisible in thinking about its impact on health implications. The North American Menopause Society has devoted a good 25 years of research addressing the end of the reproductive lifespan and its health impact on such conditions as cardiovascular risk and disease, diabetes, metabolic syndrome, and osteoporosis.
The American College of Obstetricians and Gynecologists (ACOG) and American College of Pediatricians (ACPeds), have both advocated for making the menstrual cycle the fifth vital sign, but mainly focus on issues around the onset of menses (menarche) and the timing of puberty. Even though this tells us a lot, guidelines don’t go beyond that, even though there are implications across the reproductive lifespan, well past teen years and pregnancy. Current guidelines were created a decade ago and have not been expanded, and I don’t know how well they are being followed. We should think about… Who is using these guidelines? How effective are they? Are there better ways to include the menstrual cycle as part of routine medical history and physical? What are educational programs and public health awareness campaigns that could endorse and include the menstrual cycle?
*Blog post has been edited for clarity and length.