195. Menopause Hormone Therapy: What the WHI Got Wrong and What the FDA Finally Fixed | Lauren Spivack, MD

Dr. Lauren Spivack is a board-certified OB-GYN, Menopause Society Certified Practitioner, and fellowship-trained minimally invasive gynecologic surgeon. She treats patients in South Jersey and through the evidence-based telehealth platform Alloy (https://www.myalloy.com/). In this episode, we break down the Women's Health Initiative, the FDA's 2025 removal of the black box warning from estrogen products, the newly named musculoskeletal syndrome of menopause, testosterone in women, and why the formulation you choose matters more than most providers realize. What We Discuss: 00:00 HRT Timing Window 00:25 Meet the Hosts 01:19 Dr Spivack Background 02:47 Pelvic Pain to Menopause 03:34 Menopause Care Gaps 09:19 Defining Menopause Stages 11:01 WHI Study Breakdown 19:37 Why Age Matters 21:59 Recognizing Symptoms 25:32 Musculoskeletal Links 27:57 Team Based Referrals 31:33 FDA Label Update 34:23 Bioidentical vs Compounded 36:51 Vaginal Estrogen GSM 39:43 Systemic Options and Risks 45:54 Dosing and Expectations 46:57 HRT Starting Doses 48:08 Progesterone Dosing Basics 48:53 Perimenopause and HRT 51:16 Breast Cancer Risk Talk 55:12 When HRT Is Not Right 58:39 Lifestyle and Sleep Focus 01:01:46 Progesterone Only Option 01:03:04 Testosterone for Women 01:07:13 Labs and Monitoring 01:11:56 HRT Hype and Telehealth 01:20:51 Overtreatment and Pellets 01:23:33 Fixing Menopause Care 01:26:25 Putting Health Back 01:28:43 Wrap Up and Disclaimer Studies & Literature Mentioned: WHI Original Trial: Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women (https://pubmed.ncbi.nlm.nih.gov/12117397/) (Rossouw et al., JAMA 2002) WHI 30-Year Review: The Women's Health Initiative Randomized Trials and Clinical Practice (https://pubmed.ncbi.nlm.nih.gov/38691368/) (Manson et al., JAMA 2024) Musculoskeletal Syndrome of Menopause: The Musculoskeletal Syndrome of Menopause (https://pubmed.ncbi.nlm.nih.gov/39077777/) (Wright et al., Climacteric 2024) FDA Announcement: HHS Removes Misleading FDA Warnings on Hormone Replacement Therapy (https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy) (November 10, 2025) HHS Fact Sheet: FDA Initiates Removal of Black Box Warnings from MHT Products (https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html) Veozah (Fezolinetant): FDA Safety Communication on Liver Injury Risk (https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due) Concepts & People: Dr. Vonda Wright (https://www.womensportsforummd.com/) — Orthopedic surgeon, lead author on the musculoskeletal syndrome of menopause paper Dr. Mary Claire Haver (https://thepauselife.com/) — OB-GYN, author of The New Menopause (NYT Bestseller) Dr. Lisa Mosconi (https://www.lisamosconi.com/) — Neuroscientist, Director of the Women's Brain Initiative at Weill Cornell, researching estrogen and Alzheimer's risk The Menopause Society (https://menopause.org/) — Professional organization and certified menopause provider directory Mark Cuban Cost Plus Drugs (https://www.costplusdrugs.com/) — Affordable medication option for uninsured patients Connect with Dr. Spivack: Alloy Profile: Dr. Lauren Spivack (https://www.myalloy.com/expert/lauren-spivack) Virtua/Rowan Medicine: Provider Profile (https://doctors.virtua.org/provider/lauren-spivack/2136705) LinkedIn: Lauren Spivack, MD (https://www.linkedin.com/in/lauren-spivack-937b8210/) Connect with Medicine Redefined: Website: medicineredefined.com Instagram: @medredefined (https://www.instagram.com/medredefined/) Twitter/X: @medredefined (https://x.com/medredefined) Newsletter: The Progress Note Work with Dr. Raja: Refining Health & Performance: refininghealthrx.com Dr. Raja's musculoskeletal and longevity practice (Telemedicine available in NJ, NY, PA, FL).