FDA director Martin A. Makary Affirms the Protective Value of Hormone Replacement Therapy for Women's Health in 2025
--Changing FDA Stance and Refuting Scare produced by 2002 Study.
Black Box Warnings removed for HRT
In a nationwide panel-backed news announcement, Dr. Makary supported the reversal of the FDA position and encouraged recommendations for HRT regimens to benefit women’s health. Contrary to the decades-long negative stance, or widespread ‘take away’ from the Women’s Health Initiative Study, Makary announced the time was overdue to support women using HRT to enhance healthy aging.
The 2002 study called “The Women’s Health Initiative” (WHI) caused many physicians to hastily stop prescribing ALL HRT regimens to women. In her 2009 book, Hormones and Your Health, Dr. Winnifred Cutler extensively reviewed and showed the flaws of this WHI study which used 2 non-bioidentical hormones:
- The estrogen (Premarin) was derived from horse urine
- The progestin (medoxyprogesterone acetate) was an unnatural synthetic instead of progesterone.
- That combination “appeared” to lead to increase cases of breast cancer.
Human bioidentical hormones which have shown to be free of these problems were not used or investigated in the WHI study participants. Nor was the regimen based on the knowledge of how bones thrive when half the month omits progesterone to mimic the natural cycle of healthy fertile women.
Athena Institute offers extensive information for women to learn about HRT and what it can do for their health and wellness
Dr. Cutler has been studying the benefits of Hormones since the early 1980s. In 1984 she co-authored a Medical Textbook with her mentor and developer of the oral contraceptive Celso Ramon-Garcia, M.D. entitiled The Medical Management of Menopause and Premenopause: Their Endocrinologic Basis which was published by Lippincott, Co. This book is a medical textbook for the internist, the gynecologist/obstetrician, the general surgeon, the psychiatrist, or, in fact, anyone who comes in contact with and treats the problems of the maturing female.
Her book for women: Hormones and Your Health: The Smart Woman's Guide to Hormonal and Alternative Therapies for Menopause was Published in 2009 by John Wiley & Sons, Inc. It provides an in-depth rebuttal to the idea that HRT causes breast cancer. And it explains which products and regimens work best and are available in inexpensively generic form since human bioidential hormones cannot be patented. Reviewed and recommended by medical professionals, and with over 890 citations and references, Hormones and Your Health offers extensive information for women to learn about the essential science about HRT and their health and wellness.
In 2009 Dr. Cutler wrote:
“Sadly, women were caught in the crossfire (of the WHI results). Many thriving hormone users gave up their HRT and suffered as their bodies began to pay the toll with a cascade of expected physiological changes that reflected their abrupt state of estrogen deficiency.” (Hormones and Your Health, p.17)
Athena Institute is grateful to have the advice from this book validated by FDA director Dr. Martin A. Makary. We share the panel he mediated in July 2025 here to help women come to their own conclusions with their personal physicians about whether or not HRT is right for them.
Press the PLAY button to watch the Short Summary
Press the PLAY button to watch the Whole Panel
Watch Dr. Cutler's 2009 interview about her book