Why I’m Furious the FDA Removed the Black Box Warning on Hormone Therapy

Why I’m Furious the FDA Removed the Black Box Warning on Hormone Therapy -  And why the WHI still matters more than ever.

I’ve tried to stay quiet. I’ve tried to “wait for all the facts” and give the system the benefit of the doubt. But this most recent move by the FDA — quietly removing the black box warning on oral estrogen and progesterone therapy — has me livid.

Why?

Because this isn’t about advancing women's health.
This is about pressure, profit, and misinformation.

And it puts women — again — in harm’s way.

🧪 Let’s Rewind: What Did the WHI Actually Ask?

The Women’s Health Initiative (WHI) was a massive, multi-year, NIH-sponsored randomized controlled trial. Its primary goal was not mysterious or convoluted. It was simple:

Does hormone therapy (oral estrogen and progesterone) reduce the risk of chronic disease in postmenopausal women?

That’s it.

Not “does it help symptoms?”
Not “does it help bone health?”
Not “how can we market different routes of administration?”
Just: Does it prevent disease in older postmenopausal women?

💥 And the Answer Was: No. In fact, worse than no.

• For combined estrogen + progestin (PremPro):
• ↑ Breast cancer
• ↑ Heart disease
• ↑ Stroke and blood clots
• Slight ↓ in colon cancer and fracture risk
• For estrogen alone (Premarin in women without a uterus):
• No increase in breast cancer — but still ↑ stroke and clot risk

And those risks weren’t hypothetical — they were statistically and clinically significant.

🧬 I Was There. Literally.

I trained under Dr. Margery Gass, one of the principal investigators of the WHI.
I helped collect the data as a resident.
I watched the landscape of women’s health change in real-time when the results came out.
And for the past 26 years, I’ve cared for women navigating menopause in the real world — with evidence, not emotion.

🧠 But What About All Those “New Studies”?

Since the WHI results were released, there’s been an explosion of commentary, smaller studies, and — let’s be honest — wishful reinterpretation of the data. Some claim:

• “The WHI used the wrong kind of hormones.”
• “The women were too old.”
• “That was then — we know better now.”

Let’s be clear:
None of those critiques invalidate the WHI.
They add context — not contradiction.

No subsequent trial has replicated the WHI’s size, rigor, or power.
None has proven hormone therapy is safe or preventative in older postmenopausal women.
And none justifies removing black box warnings that were placed there to protect patients.

🚨 So Why Did the FDA Remove It?

Because manufacturers want to market “bioidentical” formulations as safer or more “natural.”
Because influencers (including some MDs) are cashing in on hormone protocols.
Because menopause is trending — and with trend comes money.

But clinical guidelines from respected bodies like:

• The North American Menopause Society (NAMS)
• The US Preventive Services Task Force
• The American College of OB/GYNs (ACOG)
  ...still do not recommend hormone therapy to prevent chronic disease.

And none recommend using hormone therapy long-term without strong individual clinical justification.

💬 So Here’s My Stand:

I'm not anti-hormones.
I prescribe them — with care.
I walk women through their options — with context.
I respect women’s intelligence, experience, and autonomy.

But what I won’t do is pretend the WHI didn’t happen.
I won’t lie to women to sell comfort.
And I will not stop speaking truth just because it’s inconvenient to the industry.

🩺 The Takeaway:

• Hormone therapy is an important tool — especially for symptom relief in early menopause.
• But it is not a cure-all, and it is not risk-free — especially in oral form and in women over 60.
• The WHI remains the gold standard for evaluating long-term health risks.
• The FDA's removal of the black box warning does not mean the risks are gone — it just means they’re no longer required to be front and center.

Perfect — here’s a clear and empowering “Take Action” box to include at the end of your article. It gives your readers tangible next steps without overwhelm — and gently brings them back into your ecosystem.

✅ TAKE ACTION: How You Can Be Part of the Change

You don’t need a white coat to move the needle on women’s health. You just need your voice, your curiosity, and a refusal to settle for half-truths.

Here’s how to start:

💬 Ask better questions.

• When you hear health advice, ask: What’s the evidence? Who funded it? Is this backed by clinical trials or just confidence?

📣 Speak up.

• Contact your elected officials and demand more NIH funding for women’s health — especially menopause, metabolism, and midlife research.
  ➤ Find your representative here

🧪 Support real science.

• Follow researchers and organizations doing the hard work:
• The North American Menopause Society (NAMS)
• Society for Women’s Health Research (SWHR)
• WHI alumni + menopause-trained clinicians (like me!)

📥 Stay informed. Stay connected.

• Subscribe to this newsletter and forward it to a friend who deserves truth, not trendy BS.
• Visit embracethechangemd.com to learn about upcoming educational sessions, virtual consults, and evidence-based support for insulin resistance, menopause, and metabolic health.

💖 Remember this:

You are not too complicated. You have not been forgotten. You are simply operating in a system that hasn’t caught up with you — yet.

Let’s change that. Together.