The HRT Scandal: How Misinterpreted Science Deprived Millions of Women of Essential Healthcare

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The year 2002 marked a catastrophic turning point in women’s healthcare that continues to leave its mark to this day. A single study in menopausal women, misinterpreted and sensationalised, led to one of the most damaging medical scandals of our time, depriving an estimated 20 million women of hormone replacement therapy (HRT) and creating decades of fear-based medicine that continues to harm women worldwide.

Medical Update: This article was completed prior to the FDA’s November 10th  announcement removing the longstanding “black box” warning on menopausal hormone therapy, a historic decision that ends a 23-year era of fear-based messaging rooted in the misinterpretation of the Women’s Health Initiative study. While this marks a major win for women’s health, this article highlights the profound and lasting damage caused by decades of misinformation. For over two decades, misleading conclusions restricted access to essential treatments, leaving millions of women underserved and misinformed. Twenty-three years ago, the evidence was misread as HRT causing more harm than benefit. Today, with the removal of the warning, HRT is finally recognised as a transformative and safe treatment. This shift affirms the urgency of XX innovation’s work and reinforces our commitment to spotlighting evidence-based truths that shape the future of care for women everywhere.

The Pre-2002 Landscape of HRT in Menopausal Women

Through the 1960s to 1990s, hormone replacement therapy was a standard medical practice for managing menopausal symptoms and preventing chronic disease. Initially, estrogen-only therapy was prescribed, until researchers discovered it increased endometrial cancer risk in women with intact uteri1. This led to the development of combined estrogen-progesterone treatment, a form of hormone-replacement therapy, which became the gold standard for decades, effectively alleviating menopausal symptoms while mitigating the endometrial cancer risk associated with estrogen-only treatment2 .

Epidemiological studies consistently showed that women on HRT experienced significantly better health outcomes, including reduced cardiovascular disease, osteoporosis, and improved quality of life3. However, these observational studies raised questions for potential “healthy user bias”. For example, women with access to HRT may have had better healthcare access and healthier lifestyles overall.

The Women’s Health Initiative: A Flawed Design and Catastrophic Misinterpretation

To address these concerns, the US National Institutes of Health (NIH) launched the Women’s Health Initiative (WHI) in the 1990s- a billion-dollar randomised controlled trial designed to definitively assess HRT’s risks and benefits4. The study had two parallel arms: women who had undergone hysterectomies received estrogen-only therapy, while women with intact uteri received combined estrogen-progestin therapy.

In July 2002, the WHI investigators made an unprecedented decision that would impact women’s health for decades. Before publishing their results, they held a press conference covered by major outlets announcing that they were stopping the study early due to increased risks of breast cancer, blood clots, and cardiovascular disease5. The initial messaging and  press release focused on fear and sensationalism over scientific accuracy.

However,  WHI suffered from several fundamental design and execution problems such as6:

  1. Wrong Population: The average participant age was 63, with only 30% of participants aged 50-59, the typical age when women experience menopause and would benefit most from HRT.
  1. Single Formulation: The study tested only one specific combination, conjugated equine estrogen plus medroxyprogesterone acetate (Prempro). This differs significantly from the bioidentical hormones commonly used today in modern HRT like estradiol and micronised progesterone. These bioidentical hormones are chemically identical to those naturally produced by the body and may have different safety profiles and physiological effects compared to those used in the study.
  1. Wrong Primary Endpoint: Although the study was stopped early due to signs of increased rates of breast cancer, the study actually was not powered, meaning that not enough patients were included, to allow for a robust statistical analysis of breast cancer incidence. The study was instead designed to look for evidence of heart disease prevention. Any conclusions on breast cancer rates as a result of HRT lacked statistical rigor and thus, clinical validity. Specifically, a seemingly terrifying 26% relative increase in breast cancer risk was reported. However, the actual absolute risk told a different story: for every 1,000 women taking combined HRT for one year, there would be one additional case of non-fatal breast cancer, an absolute risk increase of just 0.1%7.
  1. Ignored HRT Benefits: The researchers failed to communicate the observed positive health effects of HRT shown in the study, including: significant reduction in hip fractures (34% decrease), reduction in colon cancer (37% decrease), a decreased overall mortality, and no increase in cardiovascular disease when analysed over time8, the safety of which (in the cardiovascular context) has been supported by further studies as well9.

The Devastating Consequences

The widespread misinterpretation of the WHI study led to devastating real-world consequences. HRT usage dropped by 40–80% almost overnight, triggering billions in losses for the pharmaceutical industry and contributing to a divestment away from women’s health research10. Decades later, fewer than 4% of eligible women receive HRT, an alarming decline from rates seen 20 years ago, resulting in potentially immeasurable missed health benefits for millions of women worldwide10. Compounding the issue, a significant “brain drain” has occurred: many physicians once skilled in prescribing HRT have been replaced by a generation of doctors who lack that expertise1.

The HRT scandal represents a profound failure of medical science communication and regulatory oversight in the analysis and interpretation of the data. It demonstrates how institutional bias, fear-based medicine, and inadequate statistical analysis can deprive millions of patients of beneficial treatments.

Current research has shown that HRT, when initiated within 10 years of menopause onset, offers substantial cardiovascular protection, reducing coronary disease and all-cause mortality by up to 15-fold12. The cardiovascular risks reported in the WHI were largely due to starting therapy in older women, rather than during the menopausal transition. HRT also remains the gold standard for osteoporosis prevention, with strong evidence demonstrating significant increases in bone mineral density,  and effective prevention of vertebral fractures12. Emerging research suggests that HRT may offer neurological protection against dementia and Alzheimer’s disease when initiated during the menopausal transition, although further studies are needed to determine optimal timing13. Additionally, vaginal estrogen therapy, virtually free of systemic risks, can reduce urinary tract infections by over 50%, enhance sexual function, and greatly improve quality of life14. Despite these benefits, it remains severely underutilised, largely due to outdated FDA warning labels rooted in misinterpretations of the WHI findings14.

The path forward

The Women’s Health Initiative scandal stands as a cautionary tale of how scientific misinterpretation, media sensationalism, and institutional resistance to correction can cause immeasurable harm. An estimated 20 million women have been deprived of beneficial hormone therapy over the last 23 years, leading to increased fractures, cardiovascular disease, and reduced quality of life15. 

To move forward, it is important that healthcare professionals recognise the shortcomings of the WHI and the benefits of HRT, assessing women on an individual basis to determine the best course of treatment. Staying updated  with  evolving evidence on bioidentical hormones, testosterone therapy, and vaginal estrogen will be key to appropriate clinical decision-making. Additionally, it is pivotal to acknowledge that menopause is whole-body medicine, not simply a niche gynaecological condition. Patients should be educated  that the WHI 2002 findings do not reflect the safety or efficacy of modern bioidentical hormone therapy. Vaginal estrogen therapy, in particular, is both safe and highly effective for treating genitourinary symptoms, despite its limited use16. Women should advocate for personalised care and seek second opinions when navigating hormone-related health decisions. Importantly, avoiding all hormones is not without risk- it can increase the likelihood of osteoporosis, cardiovascular disease, and a diminished quality of life.

Nonetheless, the evidence is clear: appropriately prescribed hormone replacement therapy, using modern bioidentical formulations, individualised dosing, and proper timing, is not only safe but profoundly beneficial for most menopausal women. It’s time to move beyond the fear-based medicine of 2002 and embrace evidence-based care that puts women’s health and quality of life first.

References

  1. Cagnacci, A., & Venier, M. (2019). The Controversial History of Hormone Replacement Therapy. Medicina, 55(9). https://doi.org/10.3390/medicina55090602 
  2. U.S. Preventive Services Task Force. (2002). Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions: Recommendations and Rationale. Annals of Internal Medicine, 137(10), 834. https://doi.org/10.7326/0003-4819-137-10-200211190-00013 
  3. Tavris, C., & Avrum Bluming. (2018). Estrogen Matters: Why taking hormones in menopause can improve women’s well-being and lengthen their lives without raising the risk of breast cancer . Little, Brown Spark.
  4. Writing Group for the Women’s Health Initiative Investigators. (2002). Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial. JAMA: The Journal of the American Medical Association, 288(3), 321–333. https://doi.org/10.1001/jama.288.3.321 
  5. Vogel, L. (2017). Trial overstated HRT risk for younger women. Canadian Medical Association Journal, 189(17), E648–E649. https://doi.org/10.1503/cmaj.1095421 
  6. Clark. (2007). A critique of Women’s Health Initiative Studies (2002-2006). Nuclear Receptor Signaling, 4(e023). https://doi.org/10.1621/nrs.04023 
  7. Bluming, A. Z., Hodis, H. N., & Langer, R. D. (2025). The WHI’s Continued Misrepresentation of its Breast Cancer Claims: a Critique and Evidence. Current Obstetrics and Gynecology Reports, 14(1). https://doi.org/10.1007/s13669-025-00420-6 
  8. Simon, M. S., Chlebowski, R. T., Wactawski-Wende, J., Johnson, K. C., Muskovitz, A., Kato, I., Young, A., Hubbell, F. A., & Prentice, R. L. (2012). Estrogen Plus Progestin and Colorectal Cancer Incidence and Mortality. Journal of Clinical Oncology, 30(32), 3983–3990. https://doi.org/10.1200/jco.2012.42.7732
  9. Hodis, H. N., Mack, W. J., Azen, S. P., Lobo, R. A., Shoupe, D., Mahrer, P. R., Faxon, D. P., Cashin-Hemphill, L., Sanmarco, M. E., French, W. J., Shook, T. L., Gaarder, T. D., Mehra, A. O., Rabbani, R., Sevanian, A., Shil, A. B., Torres, M., Vogelbach, K. H., & Selzer, R. H. (2003). Hormone Therapy and the Progression of Coronary-Artery Atherosclerosis in Postmenopausal Women. New England Journal of Medicine, 349(6), 535–545. https://doi.org/10.1056/nejmoa030830 
  10. Habib, J. L. (2012, June 11). Misreporting and Poorly Presented Results Shrouded Benefits of HRT. Contemporary OB/GYN. https://www.contemporaryobgyn.net/view/misreporting-and-poorly-presented-results-shrouded-benefits-hrt 
  11.  Attia, P. (2025, May 12). #348 ‒ Women’s sexual health, menopause, and hormone replacement therapy (HRT) | Rachel Rubin, M.D. Peter Attia. https://peterattiamd.com/rachelrubin/ 
  12. Cauley, J. A. (2003). Effects of Estrogen Plus Progestin on Risk of Fracture and Bone Mineral DensityThe Women’s Health Initiative Randomized Trial. JAMA, 290(13), 1729. https://doi.org/10.1001/jama.290.13.1729
  13. Maki, P., & Hogervorst, E. (2003). The menopause and HRT. HRT and cognitive decline. Best Practice & Research Clinical Endocrinology & Metabolism, 17(1), 105–122. https://doi.org/10.1016/s1521-690x(02)00082-9 
  14. Raz, R., & Stamm, W. E. (1993). A Controlled Trial of Intravaginal Estriol in Postmenopausal Women with Recurrent Urinary Tract Infections. New England Journal of Medicine, 329(11), 753–756. https://doi.org/10.1056/nejm199309093291102 
  15. Endocrine Society. (2006). Bioidentical Hormones. In endocrine.org. https://www.endocrine.org/~/media/endosociety/files/advocacy-and-outreach/position-statements/all/bh_position_statement_final_10_25_06_w_header.pdf 
  16. Flores, V. A., Pal, L., & Manson, J. E. (2021). Hormone Therapy in Menopause: Concepts, Controversies, and Approach to Treatment. Endocrine Reviews, 42(6), 720–752. https://doi.org/10.1210/endrev/bnab011 

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