There is much controversy over women’s natural occurrence of menopause at the average age of 51 and what they should do to abate symptoms such as hot flashes and mood swings. It probably dates back to Eve in the Garden of Eden. Although the Bible states that Adam lived for 930 years, it does not give an age of death for Eve. However, I am guessing that she experienced menopause at some point and had to find ways to deal with it naturally, making it an “age-old problem.“

It was fortunate for women in the 20^th century that by1942 Wyeth Ayerst released an estrogen pill, Premarin, which was promoted as a savior for newly emancipated women to help abate menopausal symptoms. Its big surge, however, came in 1986 when the FDA announced that it and other short-acting estrogens were effective in preventing osteoporosis. Suddenly Premarin seized the day and became a drug of choice for post menopausal women to take for the rest of their lives to prevent bone loss.

Reason for Recent Controversy Over Menopause Drugs

The reason the controversy is rearing its head again in the 21^st century is that a dozen physicians and researchers participated in a panel discussion on July 17, 2025, and pleaded with the Federal Drug Administration (FDA) to stop harming women with a black box warning for local vaginal estrogen and progesterone products because they say there is no evidence, based on recent research, linking them to harm and are safe to use vaginally.

Dr. Martin Makary, the FDA  commissioner, has been an outspoken supporter of hormonal therapy (HT) and believes that the benefits outweigh the risks. He has been dismissive of findings of a heightened risk for breast cancer in the past and stated that the black box warnings on these products actually caused a “breast cancer scare.”

Other proponents for removing the black box warning say the treatment for hot flashes may prevent cognitive decline, heart diseases, and some cancers with long-term use and reduce osteoporosis-related factors. Dr. Rachel Rubin, a board-certified urologist, called for greater updated awareness and messaging around treatments for women’s urologic health because local vaginal hormones prevent more than 50 percent of UTIs. What she does not say is what to do with the other 50 percent when hormonal treatments do not work. Other doctors say that HT should begin within 10 years of menopause’s start to be safe, but an opponent, Dr. Jacques Rossouw, former leader of  the Women’s Health Initiative (WHI), claimed this idea was “magical thinking.”

The reason for the “scare” Dr. Makary spoke about was initiated more than 20 years ago when the researchers from the WHI, that focused primarily on women 50-79, started reporting in 2002 high rates of cancer, stroke, heart attacks, and  blood clots of participants using HT. The study was cancelled as a result. Ever since then doctors have been reluctant to prescribe HT and women ditched their drugs out of fear, causing a drop in sales.

The Question is: What is Wrong in History?

One proponent of removing the black box warning on HT products, Dr. Heather Hirsch, stated that “History got it wrong,” adding that we are doing more harm than good today. Speaking about history, I remember the uproar that was caused by the WHI because I witnessed it first-hand when there was much upheaval in 2002.

I also recall in the 1990s, during the heyday of taking Hormonal Replacement Therapy (HRT), as it was called then, going to a workshop as an RN when the audience was packed with other professionals in a hospital auditorium, and the presenters touted the virtues of using it, by telling the attendees that by taking HRT they could find the fountain of youth and could improve health and vitality, as well as relieve hot flashes.

I did not buy their marketing ploy then because I had four miscarriages earlier in my life, and a GYN doctor told me that I would never have a baby to hold in my arms, unless I took DES (Diethylstilbestrol). He had no other remedy to offer me. At that time, it  had  been banned in the US after being used “safely” for years, and I knew, as a nurse, that it was found to cause cancer in the pregnant mother and her daughters later in life.

What Do Opponents of the Black Box Removal Say?

Opponents of the black box removal, such as Cindy Pearson, who played a major role in the WHI stood up at the July17 meeting and asked if there would be any public input on the FDA decision regarding the label. Dr. Makary was non-committal in his answer. After the meeting Pearson criticized the composition of the panel, saying that it was unbalanced with no opposition, and there was no scientific presentation or debate by the FDA. When asked why the panel was heavily weighted in favor of proponents, Dr. Makary reportedly quipped that others had been invited, but he did not offer any details.

The critics posited that because the panel was stacked with experts to support a predetermined conclusion, it could influence FDA policy without public comment. Other criticisms were that Dr. Makary and others on the panel referred to cherry-picked data that supported their beliefs, that the citations were old, and were filled with personal anecdotes. After being asked if oral hormonal drugs that are systemic throughout the body would be targeted for black box removal beyond the local vaginal products, he replied that all drugs should be looked at. This is in spite of the fact that Dr. Manson, lead investigator at  WHI, claimed that there are no large-scale, randomized trials, referring to transdermal and vaginal treatments.

The panel convened by Makary had financial incentives to support the wider adoption of HT, with several proponents who made money for prescribing the vaginal treatment including four physicians who are members of “Let’s Talk Menopause,” an advocacy group supported by Pfizer, Bayer, and other pharmaceutical companies, according to Roni Caryn Rabin, a reporter from The New York Times. She also pointed out that several panelists don’t accept payment through health insurance and charge a whopping $1450 for an in-person appointment, which leaves out many women who cannot afford it.

Proponents believe that HT protects against cognitive changes in the brain and reduces risk of dementia. Opponents say that women have a higher risk of developing Alzheimer’s (AD)  because of sex differences. The results of a study reported on March 5, 2025, at Mass General Brigham links HT to Alzheimer’s for women over 70 who took it more than a decade earlier. In a 2023 study by Nelsan Pourhadi et al data showed that menopausal HT, such as Premarin, was positively associated with development of all cause dementia and AD even in women who received treatment at the age of 55 years or younger.

Key Lessons Doctors and Women Can Learn from Studies on HT

In a 2021 study in Endocrine Reviews on HT concepts, controversies, and approaches to treatment by Valerie Flores et al aimed at reducing confusion, the authors provided women and doctors with an improved understanding of the importance of the timing of HT initiation, type and route of administration, and of patient-specific considerations that should be weighted when prescribing and taking HT. These guidelines include a risk-benefit analysis based on clinical characteristics of the participants, especially age, the time since menopause, and  comorbidity (other disorders that can compromise safety).

What are the alternatives to HT?

It is important to note that hot flashes and mood swings frequently get better on their own. Something to consider is that some experts say that even though the risks for women under 60 are generally low, it does not mean that it’s zero. So, what are natural alternatives to HT?

• Live a healthy lifestyle that includes not smoking, getting regular exercise, and having a nutritious diet.
• Take calcium and Vitamin D to prevent bone loss.
• For heart disease or osteoporosis there are prescription drugs to help ward off these conditions. Take natural supplements for sleep and to reduce anxiety.
• For those with more severe vasomotor symptoms of hot flashes, they can try Yoga, wearing layers of loose-fitting clothing, relaxation exercises, and meditation.
• Try foods that contain plant estrogen, such as soy products and whole grain cereals.
• Experiment with herbs such as black cohosh, and vitamin E and B complexes.
• Use OTC products to prevent bladder infections, drink plenty of water, take probiotics, and use plant-based vaginal creams and lubricants for dryness.

Don’t Sweat the Small Stuff and Make Your Voice Count

Keep in mind that all of the current HT controversy comes on the heels of a wave of women in 2025 filing lawsuits against Pfizer, for developing meningiomas (brain tumors) after taking birth control injections of Depo-Provera, when information was withheld for decades from users of its dangers. Note that it is still available on the US market.

Drug companies and physicians who are sponsored by them think that women can be duped again by presenting drugs that potentially can harm us down the road because they think we lack intelligence and don’t know that we should strive to have healthier lifestyles.

I for one, will not be silenced because of my previous negative experiences with DES being offered to me during years of miscarriages after which I birthed four healthy babies using the power of my mind. I am  glad that I ripped up the DES prescription because I have a friend who calls herself a “DES baby,” whose mother took it during pregnancy. She had cervical cancer in her 20s and colon cancer in her 30s.

My Motivation for Writing this Blog

The main reason for writing this blog is twofold. One is to honor my mother who died of Parkinson’s (dementia) after taking Premarin for over 20 years post menopause. The second reason is to honor my sister who died last year from Lewy body dementia with Parkinsonian symptoms. She took an early form of synthetic birth control pills in her early 20s and used HT for many years post menopause because she trusted what she was told. The only consoling factor for me and my sister was that she was a singer, and until the end, she remembered the words of songs. So, during the celebration of the Fourth of July in 2024 at the memory care facility, she stood up and sang her last song, “God Bless America! “

To all of you independent women in menopause who are readers of this blog, I wish you freedom, joy, and prosperity in the next chapter of your lives, while unhindered by what men, like Dr. Makary, think. Afterall, why do we call it “Men-o-pause? “

Learn More

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