doctor in a white coat holding a green medicine bottle, sitting across from a patient

It’s been 18 years since the landmark Women’s Health Initiative (WHI) initial hormone therapy (HT) results. They gained worldwide attention by throwing HT “under the bus,” alleging the risks outweighed the benefits. I didn’t, and still don’t, endorse that conclusion, because estrogen therapy reduces the risks for heart disease, Alzheimer’s disease, and osteoporotic fractures among other benefits. Regardless of one’s point of view, almost 80% of women abruptly went off their HT.1 Here, I want to talk about the latest “potential” benefit of estrogen therapy… prevention of COVID-19 infection, and reduction in disease severity. Yes, you heard me, I can’t make this “stuff” up!2,3

The basics are these:

  • The severity of coronavirus infection appears to be greater in men than in women.
  • Estrogen reduces both influenza virus growth (replication) and the inflammation it causes.
  • These benefits of estrogen (replication and inflammation) are eliminated in animals when they lose ovarian function, like menopause, and are restored if those animals receive estrogen.
  • Pregnant women have high levels of reproductive hormones, including estrogen. 92% of pregnant Chinese women from Wuhan with COVID-19 had mild symptoms, and the other 8% all recovered from their disease. There were no deaths in pregnant women.

Taken together, estrogen seems to be protective against COVID-19, both the prevention of infection, and reduction in disease severity. So much so that clinicians and scientists from Stony Brook University Hospital in New York have launched a clinical trial using menopausal estrogen patches for the reduction of COVID-19 severity in both women and MEN!4,5 Yes, we are now giving menopausal estrogens to MEN. So, before you throw away your menopausal hormone therapy, think twice, it may be helpful in this COVID-19 pandemic.


  1. Sprague BL, Trentham-Dietz A, Cronin KA. A sustained decline in postmenopausal hormone use: results from the National Health and Nutrition Examination Survey, 1999-2010. Obstet Gynecol. 2012;120(3):595‐603. doi:10.1097/AOG.0b013e318265df42
  2. Suba Z. Prevention and therapy of COVID-19 via exogenous estrogen treatment for both male and female patients. J Pharm Pharm Sci. 2020;23(1):75‐85. doi:10.18433/jpps31069

fda approved addyi todayDear Patient, Supporters and Friends,

Today the FDA made #HERstory for women with the approval of a first-ever medical treatment option for women’s most common sexual dysfunction, known as Hypoactive Sexual Desire Disorder, or HSDD. You can think of this disorder (HSDD) as: distressing low desire that can affect a woman, her partner or both and that lasts and lasts and lasts for more than 6 months regardless of circumstances, mood, vacation, health, etc. After enjoying normal sexual function, and then totally losing one’s interest in or desire for sex for longer than 6 months gives you some idea of the scope and impact of HSDD.

I know all of you have been closely monitoring the national conversation over the “little pink pill” or the “female Viagra” during the last year as the drumbeat has built among organizations such as ours – and among hundreds of thousands of people across the country – for treatment options for a condition that the FDA itself has recognized as a key unmet medical need. We at James A. Simon, MD, PC have been actively involved in the development of Flibanserin, or its new trade name ADDYI, for many years and have conducted several of the clinical trials used for FDA approval right here in the Washington, DC, office. For those of you who participated in those clinical studies, we want to personally thank you. Whether you received the active treatment in those trials or the matching placebo, soon you will be able to take “the real thing.”

James A. Simon, MD, PC is proud to be a part of such a thrilling moment in women’s sexual health and for the 16 million American women currently living without a single FDA-approved medical treatment option for HSDD.

With the FDA’s action today, The Agency not only approved a first-ever medical treatment option for HSDD, it also demonstrated that there IS a viable regulatory pathway forward toward approval of additional therapies for this and other female sexual health indications. Further, Flibanserin’s (ADDYI’s) approval today, opens the pipeline for other future options yet to come for women’s sexual health. In that vein, we are currently conducting additional studies on other medications for female sexual dysfunction right here at James A. Simon, MD, PC, and we are always looking for qualified study subjects/volunteers.

Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options, and today we write a new chapter in the fight for equity in sexual health.

The entire James A. Simon, MD, PC family


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Vulvovaginal Atrophy

th_100candidiasis_vaginal_vulvovaginalThe symptoms of vaginal atrophy in postmenopausal women most commonly include dryness (the sensation of dryness unrelated to sexual activity), and dyspareunia (difficult or painful sexual intercourse). The relative proportion of these two symptoms appears to vary. Reported differences in the relative prevalence of dryness vs. dyspareunia may have more to do with the frequency and type of sexual activity in the women surveyed than the prevalence of the symptom per se.

Other symptoms include vaginal itching, discharge, pain unrelated to sexual activity, bleeding, and increased susceptibility to both vaginal and urinary tract infections. Severe narrowing, shortening and ultimately the complete obliteration of the vaginal vault can occur. When such anatomic changes result sexual intercourse becomes impossible.  Even in milder cases, dyspareunia and reduced vaginal lubrication during sexual arousal commonly result in deterioration of a patient’s sexual quality of life, with aggravation and intensification of preexisting disorders of female sexual response.

Collectively, these physiologic changes and associated symptoms can impact all stages of the sexual response cycle, including desire, arousal, and/or orgasm. Overall sexual satisfaction is diminished. It is well documented that such effects not only impact the postmenopausal woman, but also interfere with her intimate partner relationships.  And unlike other menopausal symptoms which are usually temporary an eventually cease even without treatment, the problems associated with VVA usually increase with age in the absence of treatment.

Despite the prevalence of vulvovaginal atrophy and its associated symptoms, few women suffering from them report their problem/symptoms to their physicians or other healthcare professionals. Only 20 – 25% of affected women seek treatment. Despite the adverse impact of the vulvar, vaginal, and urinary tract symptoms on their quality of life, postmenopausal woman appear to silently and stoically accept their symptoms and the associated health problems as a natural and unavoidable part of the aging process. Unfortunately, many healthcare professionals are often complicit in this, as they do not sufficiently query patients about their symptoms or inform them about the nature of the disease state.

The good news is that there exist many therapeutic options for the treatment of these symptoms, and not all of them hormonal. If your current healthcare professional seems disinterested in improving the quality of your life in this area, seek out one who does. There simply is no need to suffer in silence.

Vulvovaginal Atrophy – Are You Suffering in Silence?


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Non-Hormonal Prescription Option for Hot Flashes

Hot-Flashes1Hot flashes and its nocturnal cousin, night sweats, the highly descriptive street names for the vasomotor symptoms (VMS) experienced by as many as 80% of menopausal women, are the most common of all menopausal symptoms.

No consensus exists on the pathophysiology of menopausal VMS, although many hypotheses have been proposed. Hot flashes (HFs) are hypothesized to result from a dysregulation of the hypothalamic temperature-regulating mechanisms, triggered by a decline in estrogen levels.

Alterations in neurotransmitters such as serotonin and norepinephrine (NE) are thus likely to play a crucial role in menopausal VMS. Core body temperature (CBT) is regulated between an upper threshold for sweating and a lower threshold for shivering. Between these thresholds is a “thermoneutral” zone, within which major thermoregulatory responses (sweating and shivering) do not occur. Fine thermoregulatory adjustments within the thermoneutral zone are affected by variations in peripheral blood flow. According to this theory, heat dissipation responses of HFs (sweating and peripheral vasodilation) would be triggered if CBT were elevated such that the upper threshold was crossed.

Hormone therapy (HT) has been known to be efficacious for most women with VMS due to menopause. Current clinical guidelines for HT recommend using the lowest dose for the shortest duration to relieve symptoms and reach treatment goals. Dose, route of administration, and duration of use should be tailored to the needs of each woman, and periodic reassessment of symptoms is required to evaluate whether a change of treatment is necessary. However, VMS recur in approximately half of women after discontinuation of HT. Certain health risks may preclude the use of HT in some patients, and some menopausal women with VMS who would otherwise be suitable candidates for HT prefer not to initiate or continue such treatments for a variety of reasons, including concerns about potential side effects.

When hormone therapy is not suitable or if there is an unwillingness to take HT, or if a woman simply prefers a non-hormonal therapy, the prescription medication, BRISDELLE, offers women and practitioners an FDA-approved, non-hormonal pharmacologic treatment option for moderate to severe VMS due to menopause. BRISDELLE® (paroxetine) 7.5 mg is a low-dose selective serotonin reuptake inhibitor (SSRI) shown to be efficacious in treating moderate to severe VMS associated with menopause. This dose is lower than those used in treating psychiatric disorders. BRISDELLE is not indicated for depression or any other psychiatric condition. BRISDELLE’s efficacy, safety and tolerability were demonstrated in rigorous clinical trials specifically designed to treat moderate to severe hot flashes due to menopause

The median age of natural menopause is 51.3 years. Women of this age are no longer old and could expect to live an additional active 20 – 30 – 40 years with good health habits and proper medical care. There is no need to debilitate yourself by neglecting any condition for which there are suitable therapies available.

Talk to your doctor or health care professional about your options!


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Opposition to the “Pink Pill” –  New View Campaign Has an Old View (Part 1 of a 4-Part Series)

During the public hearing portion of the advisory committee meeting, most of the testimony came from women seeking approval of the drug. However, there were some naysayers. Their arguments against approval boiled down to 4 perspectives. In my opinion, the arguments against the drug miss the mark.

The view is presented that development of flibanserin represents “medicalization” of a disorder that can be treated effectively with psychotherapy and education. This perspective is best embodied by an organization called the New View Campaign.

Refuting this perspective, however, is research in animal models that clearly demonstrates that HSDD (or its equivalent in animals) is the result of an imbalance between dopamine and norepinephrine on the positive end and serotonin on the negative end. These findings are supported by functional magnetic resonance imaging (MRI) and positron emission tomography (PET) scans of the brains of women with HSDD who are shown erotic stimuli. The scans demonstrate that their brains respond differently from those of normal women. So if it’s all about education and counseling, why are the brains of women with HSDD functioning differently?

I would argue that, if depression and HSDD are both abnormalities of the serotonergic system (flibanserin is essentially an SSRI), then how can depression be a biologically based disorder but HSDD can’t? In my opinion, the New View Campaign isn’t new at all.

Continue readingOpposition to the “Pink Pill””

female joggers

It’s not too late to help the next generation of women by reviewing the Women’s Health Initiative

Ten years ago, the Women’s Health Initiative dropped a bombshell when it reported that hormone replacement therapy (HRT) increased a woman’s risk for heart disease,female joggers stroke, pulmonary embolism and breast cancer. What followed this announcement was nothing short of hysteria — millions of frightened women threw away their hormones and the medical community became extremely reluctant to prescribe hormone therapy to women suffering with menopause symptoms.

Why did this happen?

I could go into great detail about what I see as flaws in the Women’s Health Initiative’s reporting methods. But when it comes down to it, I firmly believe the Women’s Health Iniative jumped the gun and didn’t take the time to thoroughly evaluate and vet its initial findings before reporting on the estrogen-progestogen portion of the study. Further analysis by age or time since menopause tells a different story altogether, a story of little risk whatsoever for them women most likely to need symptomatic relieve, women ages 50-59. And for this, countless women will continue to pay the price, twofold. First, women will continue to suffer from the always unpleasant/sometimes debilitating symptoms of menopause. Second, the very women the study was supposed to help, those who had hysterectomies and the most severe symptoms are now at an increased risk for developing heart disease and osteoporosis. That’s right! Reanalysis of WHI data clearly show that women within 10 years from menopause who took estrogen therapy actually reduced their risk for developing heart disease, breast cancer, and fractures.

How can we make things right with the Women’s Health Initiative?

It’s time to stop living in the past. Now is the time for an independent evaluation of the Women’s Health Initiative publications to determine whether or not the data supports its original conclusions. What’s more, there needs to be an FDA advisory committee created to reexamine the black box labels on postmenopausal hormones. In particular, there needs to be a separation of advisories when it comes to estrogen only products typically used in women with a hysterectomy, and estrogen-progestogen products for women with their uterus.


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