Recently, the FDA convened an expert panel on menopause and hormone replacement therapy (HRT) for women, bringing together clinicians and researchers to discuss this critical, often misunderstood, area of women’s health. While the intention was to shed light on current evidence, the discussion underscored how ingrained certain myths and misinformation, often perpetuated by outdated interpretations, affect women’s care. We’re here to help correct the record and guide you toward applicable, accurate information.
Beyond the Myths: What We Know, What’s Needed, and Your Options
The panel illustrated that while we don’t know a lot as definitively as we’d like—especially concerning nuances like perimenopause or applying broad data to segmented populations (e.g., by race/ethnicity, as more granular data is needed for applicability)—the will to move faster and apply personalized medicine approaches is growing. More research is needed to fill these gaps, but options are available in the meantime.
As you engage with your healthcare provider about these complex topics, empower yourself by asking:
- What are my risk factors? (Family history and genetic factors)
- Cardiovascular, cancer, lifestyle (smoking, alcohol consumption), age,
- Medication usage (concomitancy issues and drug interactions)
- Does this option have FDA-clearance or approval?
- Is the product manufactured under Current Good Manufacturing Practices (CGMP)?
- Are the ingredients pharmaceutical-grade ingredients?
At FemmePharma, we know that informed choices empower women. With our over two decades of experience running clinical trials and a background steeped in women’s healthcare research, we understand the subtleties of this science. Our understanding enables us to develop our Mia Vita® product line that meets the highest standards of safety and efficacy, aligning with the call for evidence-based solutions that reflect the current science.
We want to give a heartfelt shout-out to the FDA for convening this crucial panel and demonstrating a commitment to transparency and collaboration. As FDA Commissioner Dr. Marty Makary noted, for too long, women’s health issues have been “sidelined, downplayed, underfunded, and underappreciated.” The overwhelming message from the experts is clear: it’s past time to stop overstating risks and promoting fear, based on outdated information. Women deserve policy that reflects current evidence and not outdated myths. With additional research and data in subpopulations, we can design options that may be available to manage symptoms and prevent long-term health consequences, offering life-enhancing and life-saving benefits for countless women.
We spoke with our CEO, Gerie, about The (M) Factor: Shredding the Silence on Menopause (she’s in it!), why this documentary is so important, and what she wishes people knew more about when it comes to menopause. Our interview has been edited for clarity.
FP: The M Factor is reaching a lot of people. Why do you think it is the right time for this kind of a film?
Gerie: Women are concerned that hegemonic masculinity is rearing its ugly head. The combination of ageism and misogyny is particularly apparent when it relates to women who can no longer bear children. However, women are a force and the sheer number of women in this phase of life creates a powerful sisterhood. Menopause is a time of rebirth! It’s a time of liberation from issues of menstruation and childbearing when our sexual self-confidence can flourish.
FP: In the film, you speak about over-the-counter supplements, which are distinct from prescribed medication for women in menopause. How would you discuss the relationship between Hormone Replacement Therapy (HRT) and taking supplements?
Gerie: HRT is one option women may consider in consultation with their healthcare practitioners. Diet, exercise, and supplements should be part of the tool kit for menopause. Intimate skin moisturizers and personal lubricants help keep the genitalia hydrated and supple. All of these may work synergistically with HRT, or alone.
FP: What is one fact about menopause you think has been under-discussed when it comes to the social conversation on menopause?
Gerie: Mental wellness should be front and center. Women disproportionately suffer from major depressive disorder and this can be exacerbated during the hormonal roller coaster of perimenopause and menopause.
FP: What is a woman?
Gerie: A woman is a force of nature—physically and emotionally strong. We deal with adversity, and we are resourceful. Women persevere.
FP: Do you think the medical field has recovered from the 2002 World Health Institute (WHI) study claiming that hormone therapy is unequivocally linked to breast cancer?
Gerie: We need to refrain from condemning the WHI. We learned a lot from the WHI that has opened up opportunities to identify where we should refocus our research efforts. The real need is to invest in research to study diverse populations including Black and brown women, and various ethnicities, and the pharmacokinetics and pharmacodynamics of HRT in various subpopulations. Medical practitioners need to have hard data to make informed decisions about what to recommend, to whom, and the appropriate therapeutic dose/dosing regimen.
FP: If there is one thing you want people to take away about understanding menopause, what would it be?
Geri: Menopause is not a disability! Education about the transitions between puberty, parenthood, perimenopause, menopause, and post-menopause should take place in sex education at middle and high school levels. These natural life cycles women go through, and may go through if they become parents, should be a significant part of professional and medical school curricula.