Consider This from NPR

Episode: FDA Reverses Decades of Guidance on Hormone Therapy for Menopause

Air Date: November 10, 2025
Host: Juana Summers
Guests: Dr. Marty Makary (FDA Commissioner), Dr. Joanne Pinkerton (Menopause Specialist)

Episode Overview

This episode examines the FDA’s landmark decision to remove the black box warning — the strongest caution for prescription drugs — from hormone replacement therapy (HRT) for menopause. Host Juana Summers, along with expert guests Dr. Marty Makary and Dr. Joanne Pinkerton, discuss why the change was made, the evolving science around HRT, and what this means for the millions of women experiencing menopause symptoms. The conversation covers historical context, clinical evidence, risks and benefits, and implications for patients and providers.

Key Discussion Points & Insights

1. The History and Impact of the Black Box Warning

• [00:00 – 01:08]
  • In 2002, a major Women’s Health Initiative (WHI) study found risks — cardiovascular disease, breast and uterine cancer, stroke, and dementia — linked to HRT, prompting the FDA to add a black box warning in 2003.
  • As a result, HRT prescriptions plummeted (Dr. Makary: “Prescriptions for hormone replacement therapy plummeted. In the United States, women flushed their pills down the toilet. 50 million plus women have not been offered the incredible potential of health benefits of hormone replacement therapy because of medical dogma.” [00:13])
  • Dr. Joanne Pinkerton, a menopause specialist, notes many women still suffer debilitating symptoms due to fear and stigma attached to hormone therapy.

2. Evolving Medical Understanding

• [01:08 – 02:55]
  • More recent analyses show HRT can be safe — and beneficial — for women under 60 or within 10 years of menopause.
    • Dr. Pinkerton: “When we looked at all the data, not just the WHI, we realized that for women who were under 60 or within 10 years of menopause, it was not only effective, it was safe and actually had benefits on preventing heart disease, potentially preventing fractures, treating hot flushes and night sweatshirts.” [01:08]
  • HRT dramatically improves quality of life for many, reducing symptoms like night sweats, brain fog, and recurrent urinary tract infections.
    • Dr. Pinkerton shares a compelling case: “One of the most gratifying parts of my job is to take somebody who is absolutely miserable... And within, you know, four to eight weeks, they are dramatically improved.” [01:37]
    • She describes a patient who returned to horseback riding after resolving UTIs with vaginal estrogen: “She walks in smiling and she goes, I'm horseback riding again. And she hasn't had any urinary tract infections since she became regular and faithful with her vaginal estrogen.” [02:32]

3. The FDA’s Decision and Rationale

• [03:03 – 04:50]
  • The FDA, led by Dr. Makary, is removing the black box warning based on nuanced, updated data.
    • “Well, the fear machine did start in 2003... But then it got deemed a carcinogen. Based on this study. Turns out... there was no statistically significant increased risk of breast cancer. There was a lower rate of breast cancer in the estrogen only group. And so it ends up being very nuanced.” [04:58]
  • Makary underscores profound cardiovascular and cognitive benefits when HRT is started soon after menopause: “The cardiovascular benefits are profound when hormone replacement therapy started within 10 years of the onset of menopause.” [05:40]
  • The FDA’s new approach aims for clarity and better patient information. Nuances and individual risk are now included in package inserts, not a blanket warning.

4. Risks, Contraindications, and Individualization

• [07:32 – 08:48]
  • Risks of HRT remain, especially if started late (>10 years post-menopause), due to hardened blood vessels and increased clot risk.
    • “When started more than 10 years after the onset of menopause, then you actually see some of these risks...” [07:37]
  • Major contraindications: history of blood clots, active or past breast cancer; women with a uterus should also take progesterone to mitigate cancer risk.
  • For the majority: “The vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy.” [08:51]

5. FDA’s Fast-Tracked Process

• [09:34 – 10:34]
  • The agency shortcut its usual, lengthy review, convening diverse outside experts directly and responding to petitions ignored for nearly a decade.
    • “We didn't go through the long, bureaucratic, expensive process of bringing in conflicted experts... We brought in a range of diverse medical experts who passionately made the case for stopping this fear machine by removing the black box warnings...” [09:43]

6. Balancing Benefit and Risk — Avoiding Overcorrection

• [10:34 – 11:57]
  • Still, Dr. Makary cautions: “We can argue whether or not the old type of progesterone used... may have slightly increased the risk of breast cancer... But no clinical trial has ever found that it increases the risk of breast cancer mortality.” [10:55]
  • He stresses the conversation should be individualized and evidence-based — not dominated by past fears or new hype.

Notable Quotes & Memorable Moments

• On the power of the black box warning:
  • Dr. Joanne Pinkerton: “I have patients who pick up the medication, read the black box label warning, and they get scared and decide not to use it.” [02:04]
• On data and empowerment:
  • Dr. Marty Makary: “Women lived longer and felt better. But then it got deemed a carcinogen... There was a lower rate of breast cancer in the estrogen only group.” [04:58]
• On risk and medical nuance:
  • Dr. Makary: “The long term benefits are remarkable and massively misunderstood. It reduces the risk of bone fractures later in life by 50 to 60%... It reduces cognitive decline by up to 64% in one study, reduced the risk of ulcer by 35%...” [06:38]
• On accelerating FDA decisions:
  • Dr. Makary: “We are getting things done in this administration at the FDA, we're getting things done. They were talking about removing or banning a food dye for 35 years... Within weeks, we took action...” [09:43]
• On shifting the narrative:
  • Dr. Makary: “50 million women have been denied or talked out of hormone replacement therapy, in part because of the fear machine...” [10:55]

Timestamps for Key Segments

• History of the warning & collapse in HRT prescribing: 00:00 – 01:08
• Clinical experience and benefits of hormone therapy: 01:27 – 02:55
• FDA’s rationale for removing the black box: 04:58 – 07:06
• Details on risks and individualized recommendations: 07:32 – 09:34
• FDA’s process for the reversal decision: 09:34 – 10:34
• Cautions about overcorrection and summary: 10:34 – 11:57

Tone & Language

The conversation is assertive, clear, and nuanced — balancing decades of medical caution with contemporary evidence. Both experts emphasize moving away from fear-based medicine and toward individualized care, while maintaining a respect for complexity and risk.

Summary prepared for listeners seeking an in-depth understanding of this pivotal FDA decision and its implications for menopause treatment.