By Dr. David LaMond, Medical Director, Blue Sky MD
If you’re a woman navigating menopause, chances are you’ve heard conflicting messages about hormone replacement therapy (HRT)—especially estrogen. For years, women have been told to avoid it at all costs, based largely on one study from 2002 that caused widespread confusion, fear, and—unfortunately—suffering.
That may finally be changing.
On July 17, 2025, the FDA hosted a historic roundtable with over 400 experts, including clinicians, researchers, and patients, to reassess the safety and benefits of HRT. I want to share what came out of this important meeting and how it aligns with what we’ve been practicing for years at Blue Sky MD.
The 2002 WHI Study: A Misinformed Legacy
For decades, the Women’s Health Initiative (WHI) study has shaped public and medical opinion about estrogen therapy. But there’s a catch: that study was based on women who were, on average, 63 years old, many more than a decade past menopause, and it used hormone formulations that are rarely used today.
Newer research tells a different story.
When to Start Estrogen for Menopause: The “Critical Window”
Experts now agree that when estrogen is started within 10 years of menopause, it can offer powerful benefits:
1. Heart Health:
Estrogen can reduce the risk of heart disease by up to 50%, especially when delivered through the skin (transdermal).
2. Bone Strength:
It prevents bone loss and significantly lowers the risk of fractures.
3. Brain Function:
Early estrogen use may protect against cognitive decline and Alzheimer’s disease.
4. Emotional Well-being:
For many women, it restores sleep, energy, mood, and libido, often after years of suffering.
“Estrogen, when timed correctly, is one of the most powerful disease prevention tools we have.”
— Dr. Marty Makary, Johns Hopkins surgeon and FDA panelist
The Black Box Warning Problem
Today’s estrogen products still carry a black box warning, the FDA’s strongest caution label. But that label is based on outdated drugs, older women, and oral forms of estrogen—not on safer, modern therapies like transdermal estradiol or vaginal estrogen.
At the roundtable, doctors called on the FDA to:
- Update these warnings to reflect current science.
- Differentiate between delivery methods (patch, gel, vaginal tablet, etc.).
- Help women and providers make informed, personalized choices.
Real Women, Real Stories
Some of the most moving moments came from women who shared their experiences of being misdiagnosed, dismissed, or treated with antidepressants instead of hormones. Many said they felt like they were “losing their minds”—until they finally received proper care.
Their stories are heartbreaking, and far too common. But they also highlight what’s possible when women are heard, believed, and given the right treatment.
What This Roundtable Means for You
At Blue Sky MD, we’ve always believed in evidence-based, individualized menopause care. We use bioidentical hormones, prioritize non-oral delivery methods, and monitor each patient’s progress with care and compassion.
The FDA’s roundtable confirms what we’ve seen in practice for years: estrogen, when used properly, is not only safe—it can be life-changing.
If you’ve been told “you just have to deal with it,” or if you’ve tried everything except HRT, I encourage you to reach out. There’s never been a better time to explore safe, effective options for reclaiming your health during menopause and beyond.
Next Steps
The FDA has opened a public comment period, and regulatory changes may be coming soon. We’ll keep you informed every step of the way.
In the meantime, we’re here to help. Schedule a consultation and let’s talk about whether hormone therapy is right for you.
You can watch the full FDA roundtable on Estrogen here:
