DAVID LIM and LAUREN GARDNER, Politico; July 15, 2025
MENOPAUSAL THERAPY IN FOCUS
The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet issue for Commissioner Marty Makary that’s separately garnered attention in the states and on social media.
The agency’s X post announcing the event billed it as a forum to “discuss treatments, education, and comprehensive care beyond symptom management.” In a video posted Monday afternoon, Makary said the meeting would “address the evidence and medical dogma in this field.”
Background: An NIH-backed clinical trial of hormone therapy’s benefits and risks to prevent chronic diseases like heart disease was halted in 2002 after investigators said the risks of breast cancer, blood clots and stroke outweighed its symptom-relief properties.
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Makary focused a chapter of his 2024 book “Blind Spots” on the controversy, blasting the study’s administrators for misinterpreting the data. He touted recent studies suggesting hormone therapy could cut risks for heart attacks and cognitive decline “better than billion-dollar drugs.”
The asks: The slate of panel speakers that HHS shared with POLITICO features some doctors whom Makary namechecked in his book — and at least two researchers whose analyses of WHI data have supported its safety in younger women closer to perimenopause onset who don’t have underlying risks for heart disease or breast cancer.
It also includes doctors who promote hormone therapy for menopause. At least three speakers serve as medical advisers to a group petitioning the FDA to remove the boxed warning from the label for vaginal estrogen products, arguing that it improperly deters providers and patients from using them. Dr. Janet Woodcock, the agency’s former top drug regulator, rejected a similar petition in 2018, finding that any label changes should be supported by “well-controlled studies.”
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The caution: Diana Zuckerman, president of the National Center for Health Research, disagrees with criticism of the label, arguing it’s “very balanced” because it encourages providers to prescribe the lowest possible dose that works for as short a time as possible.
“That’s good advice for pretty much any pharmaceutical” besides antibiotics, she added.
The process: Zuckerman also expressed concern about the “expert panel” approach Makary has taken since becoming commissioner, especially given Makary’s promotion of hormones’ benefits in his book. The event lacks an open public comment opportunity, and the agency had yet to publicly post the speaker list Monday evening despite sharing it with POLITICO.
“It’s a very one-sided presentation, and interestingly, he criticizes NIH for their study — for being one-sided on how they presented — and he’s really equally one-sided on the opposite side,” Zuckerman said.
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