11/16/2025
Hormone Therapy—Bombshell Drop
I am a Board Certified OBGYN physician practicing for 30 years. I have devoted a significant part of my career to minimally invasive gynecologic surgery and the treatment of menopausal disorders. I am a hormone replacement doctor and consider myself an expert in HRT. While I am a physician, I am not your physician in this format and I am not giving individualized medical advice. I am sharing my beliefs that are based on evidence-based literature. I recommend that you consult with a specialist in hormone replacement therapy for your individual needs and concerns.
November 10, 2025 will be remembered as a monumental date for Women’s Health! The FDA removed the black box warning on hormone replacement therapy for menopause. Phone calls, voicemails, emails, and direct messages have been non-stop since I posted my opinion. Instead of trying to answer each person individually, I have decided to post a Q&A. I will answer the questions in this format that have been presented to me. If you have questions, I will address them here as well. Remember this format is public and you will be sharing your concerns or questions in a public format.
QUESTIONS:
What is a black box warning?
A black box warning is the most severe safety-related warning issued by the United States Food and Drug Administration (FDA). It alerts healthcare providers and consumers to the risks of serious and/or life-threatening side effects to a medication.
What did the black box warning say about Estrogen/Estradiol medications used in hormone replacement (HRT)?
The FDA black box warning on hormone therapy products was placed on HRT in 2003. It simply informed patients and their providers that using HRT increased the risk of cardiovascular disease, heart attack, blood clots/stroke, breast cancer, dementia and uterine cancer. These risk were based on a study released a year earlier, 2002, called the Women’s Health Initiative (WHI). The WHI has been proven over the past 23 years to be a flawed, prematurely released, misinterpreted study. More to come on WHI!
Why is the WHI so important?
This long-term study was funded by the National Heart, Lung and Blood Institute and was started in 1991. The NIH funded this study with a budget approaching $625 million over 14 years. The study was designed to evaluate hormone replacement therapy and possible links to cancer, heart attacks, and bone fractures in postmenopausal women. Over 161,000 women were enrolled in this study. The hormone arm of the study was halted in 2002 with a reported increase risk of heart disease, breast cancer, blood clots, stroke and possible dementia for post-menopausal women who received hormone therapy. HOWEVER, there were several flaws including focusing on women much older than the average age of menopause. Specifically, the average age of women enrolled in the study was 63. The average age of women in the United States entering menopause is 51-52. This diluted the results for the younger women and also did not take into account that many of the older women who were enrolled already had medical problems leading to heart disease, strokes, blood clots and neurodegenerative disease.
The results were “leaked” or disseminated by a small group of the investigators without consultation with the full panel in July 2002. This was done through a press conference before the complete article was published and it was not subjected to a complete peer review by the entire panel of investigators. The news media ran with the results and it has become one of the most if not the most devastating setbacks to women’s healthcare.
What is so devastating about the WHI results?
In 2002 approximately 40-50% of women eligible for HRT (menopausal) were being prescribed treatment. After the release of the study results, women were scared to take them, providers quit prescribing HRT and treatment plummeted. It is estimated that only 5-7% of eligible women are currently taking HRT due to the release of the WHI. Simply stated, approximately 50 million women have been denied appropriate therapy for the past 23 years. 80% of menopausal women are candidates for HRT. FDA COMMISSIONER MAKARY said in a September 2024 podcast appearance that, though the “data never supported” the conclusion that hormone replacement therapy increases breast cancer rates, “80 to 90% of people, including doctors” still believe it does.
Why does my doctor not offer HRT?
Many healthcare providers were scarred away from HRT when the results of the WHI were released. As stated earlier, 80-90% of women and their doctors still believe that HRT causes breast cancer. However, the problem is much deeper. Residency programs for OBGYN physicians stopped training their residents in the treatment of HRT. Results from all residency programs in 2013 and again in 2023 revealed that only 20% of OBGYN residents were adequately trained in menopause. However, there were some of us that saw through the initial study flaws and continued to offer HRT for the past two decades. We have been labeled lunatics, crazy hormone docs and outsiders. I do feel some relief and vindication with the recent announcement from the FDA.
What is menopause?
The North American Menopause Societies defines menopause as the permanent cessation of menstrual cycles after loss of ovarian activity (no me**es for 12 months with median age in the US of 51). However, the time around menopause is called the perimenopause and this can last 8-10 years. Symptoms can include hot flashes, night sweats (80% of women), vaginal dryness, painful s*x, anxiety, tension, nervousness, depression, low s*x drive, joint pain, back pain, sleep disturbance, increased hair growth, weight gain, gastrointestinal problems, incontinence, bladder infections, headaches, memory loss, fatigue, chest pain, palpitations as well as weight gain. This list is not all inclusive.
I heard you (Dr. DeSantis) were a pellet doctor!
I am a hormone replacement doctor. I am a Board Certified OBGYN and have provided HRT therapy for 30 years. I trained on hormone pellet therapy under the late Charlton R. Vincent, MD. Dr. Vincent offered hormone pellet therapy to patients in Laurel, MS in the 1980s for over 30 years. He went to Augusta, Georgia and trained under Dr. Robert Greenblatt. Dr Greenblatt was originally from Canada and specialized in endocrinology, gynecology and pathology. In 1941 Dr. Greenblatt published a paper on his early experiences on the use of hormone pellets. Yes, this was 1941. His work led to the development and use of subcutaneous hormonal pellets for HRT. In the 1950s he published work on the effectiveness of estrogens in managing menopause and his group helped develop the oral contraceptive pill in 1966.
I am a hormone replacement doctor that also offers hormone pellet therapy. Approximately 30-40% of my menopausal women utilize pellets. I have women in my clinic that are receiving their hormone pellets for their 49th year in 2025. I offer all forms of HRT including pills, patches, creams/gels, injectables and pellets. Most insurance companies will cover some form of HRT, however, very few insurance companies cover injections and pellets. In 2015, BCBS decided to make pellet therapy “experimental” and this led to most insurance companies following suit and discontinuing coverage for pellets. Pellets had been in use for 75 years when it was decided they were “experimental.” So I guess you can call me a pellet doctor, but I prefer to be called hormone doctor. I sit down with the patient and decide what option is best for them and individualize a treatment plan.
Do I need to take progesterone? My friend is on progesterone.
First of all let’s talk about progesterone. In the WHI, the only arm of the study that showed a slight increase risk in breast cancer was the group of women who still had their uterus (womb) and were taking estrogen (Premarin) and medroxyprogesteone acetate (a progestin). Current studies have shown no increase risk of breast cancer in women taking progesterone (a natural hormone). Progesterone is the natural hormone produced by the body, while progestins are synthetic, man-made versions designed to mimic progesterone's effects. Because they have different chemical structures, this can lead to different side effects. Natural progesterone may have some different therapeutic effects, such as impacting sleep and the brain, that progestins do not. If you still have your womb, you will need to take progesterone to off-set the risk of estrogen stimulation on your lining. Taking estrogen without progesterone can lead to the development of endometrial (womb) cancer. However, taking progesterone removes this risk. Some providers will recommend progesterone even in women who have undergone a hysterectomy (removal of the womb). Others will reserve use for women who continue to have significant sleep disturbance despite replacement with estrogen and/or testosterone.
How can I trust the recent FDA announcement?
For many years women have feared estrogen more than alcohol, obesity, heart disease and statins. The FDA finally admitted they made an error scaring an entire generation of women with untrue statements and bogus claims. The FDA based their decision on years of research including follow-up on the women in the WHI. Evidence shows a 50% reduction in heart attack risk, 64% reduction in cognitive decline and 35% lower risk of Alzheimer’s disease. There is a significant reduction in all-cause mortality (death) in women taking HRT. Over 30 trials involving almost 27,000 women revealed that HRT is not associated with an increased risk of death from cancer. In 2020, Chlebowski and colleagues reported a long-term follow-up from the WHI in JAMA on the association of HRT and breast cancer. They showed that women in the WHI who had undergone a hysterectomy had a significant lower risk of breast cancer as well as death from breast cancer than women not taking HRT. This study was based on 20 years of follow-up on women in the original WHI study. Not to mention that all the studies have shown lower risk of fracture and colon cancer.
What is the 10 year rule that I am reading about?
While starting HRT at anytime is a decision that should be made between the patient and her healthcare provider, studies show that women who benefit the most are those that begin HRT within 10 years of menopause.
What about supplements to treat menopause?
Black cohosh, Red Clover, Ginseng, St. John’s Wort, D**g quai, Evening Primrose Oil, Omega-3 fatty acid, Vitamin C, Vitamin D, Magnesium, Calcium, Zinc, Ashwagandha, DHEA, Collagen, Vitamin B12, Probiotics, Flaxseed, Milk Thistle as well as others have all been linked to menopause treatment. Black cohosh is one of the most studied supplements. It has mainly been used to treat hot flashes. Several studies have shown relief while others found no benefit. Ginseng has been associated with improved sleep and mood. St. John’s Wort has been used for mild depression. DHEA has been recommended to treat hot flashed and low libido. Calcium, magnesium and Vitamin D when combined with weight bearing exercises can help prevent bone loss and the development of osteoporosis. However, supplement therapy is treating some of the symptoms of menopause and not actually preventing disease with the exception of bone health.
Keep in mind, I am not against supplements and I personally use Bravenly products. Rush Extreme and Ignite are a part of my daily routine.
My doctor told me that I am losing bone. Will hormones help?
Let’s talk about bone health. The loss of bone mass is called osteopenia. When you lose a certain amount of bone, you can develop osteoporosis. This condition makes your bones weak, brittle and at risk to fracture. There are medications available to treat the disease such as bisphosphonates and denosumab. The only therapy shown to prevent disease is calcium, Vitamin D, weight-bearing exercises and Estrogen. In fact, Estrogen is the only medication that is FDA approved for the prevention of osteoporosis. Did you hear that? Estrogen is approved for the prevention of disease not the treatment of the disease.
Based on the mismanagement of menopausal women for the past two decades, one in two women are at risk of breaking a bone due to osteoporosis. White women have lifetime risk of a hip fracture of 1 in 6. Loss of estradiol is the main cause for bone loss. 80% of Americans with osteoporosis are women (8 million women). If a woman breaks her hip due to osteoporosis, there is a 30% chance she dies within one year. 50% of those women will never return to their pre-fracture function. Estradiol is approved for the prevention of osteoporosis, however, only 4-7% of menopause women are currently taking it. If a woman decides to stop taking her estradiol, bone mass will rapidly decrease within 6 years.
My doctor told me that I could not take HRT because my mother and my grandmother both had breast cancer.
All I can say to this statement is that your doctor told your wrong. A family history of breast cancer is not a contraindication to HRT. First of all, if you have had a hysterectomy there is no risk associated with the use of estradiol and the development of breast cancer. Studies actually show that you may have a lower risk of breast cancer than women not using HRT. If you have not undergone a hysterectomy, the only association with breast cancer is with the use of a synthetic progestin like medroxyprogesterone. The risk is still minimal and most hormone providers do not use synthetic options. You should have a discussion with you healthcare provider or one that is experienced in HRT.
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