July 18, 2025
We need to look at all of it.
Dr. Marty Makary, FDA Commissioner, after a panel convened by the FDA on “Menopause and Hormone Replacement Therapy For Women” challenged existing “medical dogma” and current black box warnings on certain hormone treatment.
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Why It Matters: This event elevated a current medical debate that has both current and future potential to impact America’s 170 million women.
Many experts on this panel challenged existing rules and regulations on the types of hormone therapy easily accessible to American women. A number of current regulations date back to a key body of research called the Women’s Health Initiative, which was released in the early 2000s and funded by the federal government. The research focused on “preventing heart disease, breast and colorectal cancer, and osteoporosis in postmenopausal women.” One of the research’s key concerns purported to show that a specific prescription hormone therapy increased the risk of breast cancer in some women; this conclusion led to widespread doubt and fear that hormone therapy in women would lead to cancer. Critics now challenge the way the research was applied in practice, and argue the lack of hormone therapy available to women, despite the intent to protect them from serious illness, has actually done the opposite — hurting their health and raising their mortality rates.
Something To Consider:
“New hormone formulations have come on the market since the W.H.I. trials were halted. Some physicians believe these products are safer, but they have not been tested in large randomized controlled clinical trials.” (New York Times)
One of the leading fundraisers for the Women’s Health Initiative was present in the panel’s audience, and said the panel did not offer enough diversity of opinion: “This panel was set up by Dr. Makary to give him public reason to take the next step forward, using a mix of cherry-picked data, old citations and personal anecdotes to defend his conclusion that hormone therapy would be good for almost every woman who goes through menopause.”
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
by Jenna Lee, Founder of SmartHER News
