https://mcdn.podbean.com/mf/web/dyr5c4/santorofinal_-_2_13_23_410_PMbwjze.mp3
EPISODE SUMMARY:
Dr. Nanette Santoro, a board-certified obstetrician and gynecologist, is one of the physicians on the review board for Fezolinetant, a non-hormonal drug designed to block the receptors in the brain that produce hot flashes. Fezolinetant is being produced by Astellas and is currently in phase three trials with the FDA. Today, we sat down with Dr. Nanette Santoro to discuss the 2002 Hormone Replacement Therapy study, what happens in your brain when you have a hot flash, Fezolinetant, and how to get a Fezolinetant prescription once it is available.
First, we asked Dr. Santoro for her thoughts on the 2002 Hormone Replacement Therapy Study, an article that created a false, dangerous narrative surrounding HRTs. She told us that at the time the study was released, no one could have predicted how bad it would be. Doctors and physicians were sent into a panic, with some even hesitating to prescribe HRTs to their clients, and she was shocked by the misinformation being spread. Even now, with better access to data and information, we still see a lack of proper education on HRTs in the medical field. Dr. Santoro said that she credits this to insufficient training in medical schools. Studying physicians and doctors are not given access to menopause education during training, which leads to them being unable to give their clients proper information on HRTs. The North American Menopause Society has certified practitioners who have sought out menopause training and is a great resource for those looking for qualified menopause doctors.
While scientists don’t know everything about hot flashes, Dr. Santoro did tell us that hot flashes are connected to the thermoregulatory center in the brain. The thermoregulatory center is located in the hypothalamus and has neurons called candy neurons. The candy neurons send signals to receptors in the brain that trigger hot flashes, and studies have shown that by blocking these receptors, hot flashes decrease. Fezolinetant, a non-hormonal drug produced by Astellas designed to block the hot flash receptors, is currently in phase three trials with the FDA to be approved to help treat hot flashes. In phase one, after animal trials, Fezolinetant was tested for toxicity and only given to a few people. During the trials, Fezolinetant was tested on women who suffer from over 20 hot flashes a day. Since the trials were done during COVID, there were some COVID related side effects distributed equally among those taking Fezolinetant and those on the placebo. However, no significant side effects were found. Some women taking the drug even reported that they were sleeping better and losing weight as a result of Fezolinetant. Dr. Santoro also mentioned that once the drug is available, women on HRTs would be able to make the switch and try Fezolinetant. Unfortunately, once the drug is approved, it’ll take time for it to be available for prescription. When asked about the timeline of Fezolinetant being put on the market, Dr. Santoro explained that once a drug is approved, it has to have its cost and copay approved. Many menopause treatments are not picked up by pharmacies and are expensive, so it’s unknown how much Fezolinetant will end up costing. FDA approved drugs also have to be put on hospital formularies, which can take months to complete.
When asked who is at risk when taking HRTs, Dr. Santoro said that the highest risk candidates are those with blood clots and breast cancer. A family history of breast cancer and an individual’s level of risk are also factors. Finally, we asked Dr. Santoro for her thoughts on how menopause is discussed in society. She told us that she has concerns about the medicalization of menopause and how many of the conversations surrounding it are anti-women. Dr. Santoro mentioned the recent New York Times article about menopause and how one of the issues brought up was how we as a society have become too comfortable with women suffering. Women don’t always feel like they can speak up and advocate for themselves, and Dr. Santoro believes that by increasing advocacy for women in menopause, we can help change the narrative and encourage more women to speak up about their menopausal experiences.
Dr. Nanette Santoro
Dr. Nanette Santoro completed her medical training in the 6-year BS-MD program at Rensselaer Polytechnic Institute and Albany Medical College, followed by residency at Beth Israel Medical Center in New York City and a fellowship in Reproductive Endocrinology at Massachusetts General Hospital, where she remained on faculty for 3 years prior to joining the faculty at New Jersey Medical School in 1988.
Dr. Santoro has had continuous NIH funding since 1989, with serial R01, R21, U10, U54 and R25 grant awards focused on reproductive endocrinology, menopause and the effects of obesity on reproduction in women. She has authored over 300 peer-reviewed scientific publications and edited 4 books. She has personally mentored over 100 students, residents, postdoctoral fellows and junior faculty, many of whom have gone on to illustrious academic careers. She has been a Board member or elected officer for the American Board of Obstetrics and Gynecology, Inc. (1996-2009), the American Gynecologic and Obstetrical Society, the American Association for Gynecologists and Obstetricians Foundation, the Society for Reproductive Investigation, the North American Menopause Society, and the American Society for Reproductive Medicine. She is Past President of the Society for Reproductive Investigation, Women in Endocrinology, and the Society for Reproductive Endocrinology and Infertility. She is President-Elect of the American Gynecologic Club. She is past Vice-President for Clinical Research for the Endocrine Society. She has been recognized by the Endocrine Society (Mentor Laureate Award 2016), the North American Menopause Society (Award for Research in Perimenopause 2004, prize paper and Tom Clarkson Research Award 2021), the International Menopause Society (Henry Burger Research Award in Perimenopause 2020), and the ASRM (Distinguished Researcher Award 2020). In 2018, Dr. Santoro was elected to the National Academy of Medicine.
Dr. Santoro has been named a Castle Connelly Best Doctor and “Best Doctor in America” for many years and has been a ‘Best Doctor’ in Westchester Magazine, New York Magazine, and 5280 Magazine. As Chair of the Department of OB-GYN at the University of Colorado School of Medicine since 2010, she helped recruit talent to make the Department #8 in the country for NIH funding in 2017, has tripled the faculty within the department, and quintupled the department’s annual revenue.
In this episode, we discuss…
- [0:01] ThePerfect3
- [2:10] Guest Introduction
- [7:13] Start of Interview
- [8:23] The 2002 Hormone Replacement Therapy Study
- [12:54] Spreading Information About HRTs
- [15:22] What Happens When You Have a Hot Flash?
- [19:24] Getting Medications into Phase One Trials
- [20:56] Who Should Not Be Taking HRTs?
- [23:45] Fezolinetant Trials
- [26:55] Getting a Fezolinetant Prescription
- [29:33] The Treatment of Menopause
- [32:14] Closing Thoughts
- [34:54] Outro
Useful Resources:
Shady Grove Fertility I [https://www.shadygrovefertility.com/]
Dr. Santoro’s LinkedIn I [https://www.linkedin.com/in/nanette-santoro-3a898598/]
Fezolinetant I [https://www.astellas.com/en/news/26126]
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