The FDA has finally vindicated Wulf Utian’s decades-long critique of the distortions and misrepresentation of the WHI HT study findings by removing the ‘black box’ warnings in menopausal hormone therapy labeling.1-3 Regrettably, in the interim millions of women have suffered unnecessary menopause symptoms and tens of thousands may have died from premature heart disease or experienced life changing osteoporotic fractures.
It is still not too late for an independent commission of enquiry to delve into the facts to prevent such a misdirection in science from happening again.
- Martin A. Makary, Christine P. Nguyen, Tracy Beth Hoeg, et al. Updated
Labeling for Menopausal Hormone Therapy. JAMA, Published Online:
November 10, 2025 doi: 10.1001/jama.2025.22259
- Utian WH. Personal Perspective. NIH and WHI – time for a mea culpa
and steps beyond. Menopause 2007;14:1056-1059.
- Utian WH. A decade post WHI, menopausal hormone therapy comes full circle – need for an independent commission. Climacteric 2012;15:320-325. http://informahealthcare.com/doi/abs/10.3109/13697137.2012.678916
2 Responses
I wish there was more transparency regarding why so many of the original WHI investigators have failed to be more forthcoming in what has seemed to be a cover-up of how the WHI results were presented and disseminated.
That is the crux of the problem. But NIH and the FDA are not likely to investigate themselves!