Transcript

The FDA will lift warnings on hormone therapy for menopause

From NPR · Episode page · Watch on YouTube

· 8 min · 1,360 words · 17 timestamped sections

This is the full, timestamped transcript of "The FDA will lift warnings on hormone therapy for menopause", an episode of NPR published November 10, 2025 (8 min, about 1,360 words). It mentions 18 people, works and ideas, including breast cancer, estrogen, hormone replacement therapy, Dr. Marty McCary, progesterone.

What is discussed, and when

  1. – 3:00: breast cancer, estrogen, hormone replacement therapy, Dr. Marty McCary
  2. – 6:00: estrogen, hormone replacement therapy, breast cancer, Circulation
  3. – 7:50: breast cancer, blackbox warnings, Cardiovascular Disease, Dr. Marty McCary

Notable quotes from "The FDA will lift warnings on hormone therapy for menopause"

  • And that's because early studies showed an increased risk of endometrial cancer, cardiovascular disorders, and breast cancer. Well, those warnings are going away. And FDA…
    about breast cancer · at
  • It reduces the risk of bone fractures later in life by 50 to 60%. That's a New England Journal study. It reduces cognitive decline by up to 64%. In one study reduced the risk of Alzheimer's by 35%. And there are cardiovascular.
    about New England Journal · at
  • Noted to be 35 30 to 50%. That is a 30 to 50% reduction in heart disease. And in a study in circulation two years ago, a 48% decline in heart attack deaths.
    about Circulation · at
  • Therapy. If a woman has a uterus, it's important for them to also take progesterone to reduce the risk of endometrial hyperplasia and possibly uterine cancer. But women who…
    about progesterone · at
  • Passionately made the case for stopping the sphere machine by removing the blackbox warnings around cardiovascular disease, dementia, and breast cancer. I mean over the last…
    about blackbox warnings · at
  • Cardiovascular benefits. ear early on in the 1920s, Mayo Clinic researchers noted that young girls who had their ovaries removed went on to have heart disease in their 30s and 40s, suggesting a profound cardiovascular protective.
    about Mayo Clinic · at

Who and what is mentioned in this episode?

People

  • Dr. Marty McCary — Person · 2 mentions · first at
    Cardiovascular disorders, and breast cancer. Well, those warnings are going away. And FDA Commissioner Marty McCary led the way on that decision, and he's here with me in studio now. Thanks for coming by.

Books & papers

Companies & orgs

  • Food and Drug Administration (FDA) — Company · 1 mention · first at
    For more than two decades, the Food and Drug Administration has warned women about the potential risks of using estrogen to treat menopause symptoms.
  • Mayo Clinic — Company · 1 mention · first at

Products & tech

  • estrogen — Product · 5 mentions · first at
    Drug Administration has warned women about the potential risks of using estrogen to treat menopause symptoms.
  • progesterone — Product · 2 mentions · first at
  • MPA — Product · 1 mention

Concepts & topics

  • breast cancer — Concept · 6 mentions · first at
  • hormone replacement therapy — Concept · 5 mentions · first at
    After a 2002 study that really hit the airwaves in the media with a big splash, scaring women out of hormone replacement therapy in the post-menopausal setting.
  • blackbox warnings — Concept · 2 mentions · first at
  • endometrial cancer — Concept · 1 mention · first at
    And that's because early studies showed an increased risk of endometrial cancer, cardiovascular disorders, and breast cancer. Well, those warnings are going away. And FDA Commissioner Marty McCary led the way on that decision, and he's.
  • endometrial hyperplasia — Concept · 1 mention · first at
    Important for them to also take progesterone to reduce the risk of endometrial hyperplasia and possibly uterine cancer. But women who have been taking this for a long time have…
  • petition — Concept · 1 mention · first at
    From the food supply. That's all artificial dyes. In this case, we are responding to a petition that was filed in 2016. It was basically blown off. It was refiled in 2025. We…
  • expert panel — Concept · 1 mention · first at
    Responding to a petition that was filed in 2016. It was basically blown off. It was refiled in 2025. We held an expert panel. We didn't go through the long bureaucratic…
  • Cardiovascular Disease — Concept · 1 mention · first at
    Stopping the sphere machine by removing the blackbox warnings around cardiovascular disease, dementia, and breast cancer. I mean over the last several years in our society and…

Places & events

Full transcript with timestamps

For more than two decades, the Food and Drug Administration has warned women about the potential risks of using estrogen to treat menopause symptoms. And that's because early studies showed an increased risk of endometrial cancer, cardiovascular disorders, and breast cancer. Well, those warnings are going away. And FDA Commissioner Marty McCary led the way on that decision, and he's here with me in studio now. Thanks for coming by.

Great to be with you, Wana. So, I mean, this blackbox warning that we're talking about, it's been in place on all estrogen treatments for more than two decades since back in 2003. the timing. Why remove it now?

Well, the fear machine did start in 2003 after a 2002 study that really hit the airwaves in the media with a big splash, scaring women out of hormone replacement therapy in the post-menopausal setting. Up to one in four Americans were taking it. Women lived longer and felt better. But then it got deemed a carcinogen based on this study. Turns out when the study results were finally released after the media announcement, 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 and the cardiovascular benefits are uh profound when estm replacement therapy is started within 10 years of the onset of menopause. So there is some nuance here, but unfortunately the fear machine has dominated the field and women have been talked out of it.

They've been denied or never offered hormone replacement therapy despite the profound short-term and long-term benefits.

Let's talk about that for a second because there is a lot of nuance here. Just spell out plainly for us some of the benefits of hormone therapy as you see them.

Yeah. So starting hormone replacement therapy around the time of menopause not only can alleviate the short-term symptoms of menopause that is the hot flashes, night sweats, mood swings, weight gain, difficulty sleeping, pain with sexual activity. There are 50 plus different symptoms and every woman experiences them differently.

You know, we were taught at medical school that some women have symptoms but they're usually mild and they're last just a couple years. Not true. 80 plus percent of women have symptoms. The average duration is eight years and for many women it is severe. They are debilitating. The long-term benefits are remarkable and massively misunderstood. It reduces the risk of bone fractures later in life by 50 to 60%. That's a New England Journal study. It reduces cognitive decline by up to 64%. In one study reduced the risk of Alzheimer's by 35%. And there are cardiovascular benefits when it's started within uh 10 years of the onset of menopause.

Does it matter if a woman is taking a pill which is systemic or using a cream which is a local treatment?

So there are pills, there are patches, there are creams and gels and so all of these products had a blackbox warning from the FDA as a part of this pylon as a part of this part of this bandwagon thinking in 2002 2003. We are removing those and putting the nuances of the risks in the package insert and the idea is to get better information in front of women.

Spell out some of these risks for us because there are still risks associated with hormone replacement therapy. Is that right?

Yeah. When started more than 10 years after the onset of menopause, then you um actually see some of these risks that are have been attributed to all hormone replacement therapy products. And that's probably because the body naturally is making estrogen and the that increases nitric oxide. It keeps the blood vessels soft and the walls soft and healthy and dilated. And so when it started such that there's not a gap where your body is without it then uh there are there are cardiovascular benefits where the reduction in heart disease um has been noted to be 35 30 to 50%. That is a 30 to 50% reduction in heart disease. And in a study in circulation two years ago, a 48% decline in heart attack deaths.

And so that is because of the effect of estrogen. So if it started too late, the blood vessels are narrowing and the theory is that they're hardening and that uh aging and atherosclerosis can then result in a situation that is prone for a blood clot with hormone therapy. Commissioner, are there women who should not be using hormone therapy?

Yes, many doctors do identify some contraindications. A woman with an underlying risk for blood clots, a woman with active breast cancer or past breast cancer, depending on the practice style of the physician, but the vast majority of women who go through menopause, which is about 2 million women a year, are great candidates for hormone replacement therapy. If a woman has a uterus, it's important for them to also take progesterone to reduce the risk of endometrial hyperplasia and possibly uterine cancer. But uh women who um uh have been taking this for a long time have reported tremendous benefits and they're talking about it on social media now. So there is a bit of an awakening.

I do want to ask you about the process here because in preparing to remove the blackbox warning, there's usually a formal, very detailed process. Things seem to play out differently this time. Tell us why. Yeah, we're 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 before I got to the FDA. Within weeks, we took action to remove nine petroleumbased food dyes from the food supply. That's all artificial dyes. In this case, we are uh responding to a petition that was filed in 2016. It was basically blown off. It was refiled in 2025. We held an expert panel. We didn't go through the long bureaucratic expensive process of bringing in conflicted experts to talk about a product. We brought in uh a range of diverse medical experts who who passionately made the case for uh stopping the sphere machine by removing

the blackbox warnings around cardiovascular disease, dementia, and breast cancer. I mean over the last several years in our society and I don't have to tell you this but there has been this increasing recognition of the health challenges the very real challenges that women face during menopause and you and I were talking about the nuance in this conversation earlier. Do you worry at all that by removing this blackbox warning that it might result in the pendulum tipping the other way and there there's now going to be an overuse of hormone therapy? Well, tragically over the last 23 years, 50 million women have been denied or talked out of hormone replacement therapy in part because of the fear machine that it hormone replacement therapy is a carcinogen. It causes breast cancer. Uh we can argue whether or not the old type of progesterone used called MPA in that original study may have slightly

increased the risk of breast cancer in women who took that uh MPA. But um no clinical trial has ever found that it increases the risk of breast cancer mortality. And if it did, that harm would be far eclipsed by the profound cardiovascular uh benefits. Uh, you know, ear early on in the 1920s, Mayo Clinic researchers noted that young girls who had their ovaries removed went on to have heart disease in their 30s and 40s, suggesting a profound cardiovascular protective effect. And so, that's the nuance conversation that people need to have.

We've been speaking with FDA Commissioner Dr. Marty McCary coming in to talk to us about the FDA's decision to remove blackbox warnings for estrogen treatments for menopause. Thank you so much for coming by our studios today. Great to be with you, Anna.

Questions about this episode

What is discussed in "The FDA will lift warnings on hormone therapy for menopause"?

In order: 0:00 breast cancer, estrogen, hormone replacement therapy, Dr. Marty McCary; 3:00 estrogen, hormone replacement therapy, breast cancer, Circulation; 6:00 breast cancer, blackbox warnings, Cardiovascular Disease, Dr. Marty McCary.

What is mentioned in this NPR episode?

18 people, works and ideas are mentioned, including breast cancer, estrogen, hormone replacement therapy, Dr. Marty McCary, progesterone, blackbox warnings. Each one on this page links to its own page with every episode that mentions it.

How long is "The FDA will lift warnings on hormone therapy for menopause"?

The episode runs 8 min; the transcript is about 1,360 words in 17 timestamped sections.

More from NPR

About this transcript: the episode's spoken words as captioned on YouTube, split into timestamped sections. Reclip.Me locates every person, work and idea in the text, keeps the time it is first named, and quotes the words around it verbatim. Last updated November 17, 2025.