USPTF Rebuttal: Why Women Still Need Pelvic Exams

Recently, the U.S. Preventive Services Task Force (USPSTF) concluded that there is limited evidence to support doing routine pelvic exams for women who are healthy and not pregnant. They say: “There is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice.”

An Absence of Evidence
Does this lack of evidence mean there is no benefit to routine pelvic exams? Absolutely not. The absence of evidence does not indicate the evidence of absence. In other words, if there is absence of or limited evidence for the benefits of routine pelvic exams that does NOT mean there is adequate evidence to recommend against them. In fact, these most recent draft guidelines don’t make much sense to me at all. Here are just a few reasons why:

  • Possibility of bias- The authors are all women from the West Coast of the US, and there isn’t a single gynecologist among them, so there is a significant absence of diversity (by gender, by geography, and by specialty) which could be a source of bias. In fact, most of the authors are not physicians, nor have they ever performed a routine pelvic exam.
  • “Insufficient” evidence- The authors note that “the current evidence is ‘insufficient’ to determine the balance of benefits and harms of the pelvic exam,” however, this didn’t deter them in drafting recommendations in favor of stopping routine pelvic exams.
  • The authors judged the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease-specific morbidity and mortality, and improving quality of life. These are all very “blunt instruments” (aka insensitive assessments) which are particularly obtuse in younger women where death and cancer related morbidity are rarely relevant, and almost never proximate in time.
  • The authors found only eight studies looking at the diagnostic accuracy of pelvic exams, and for only four medical conditions: ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes. So in the studies evaluated, the only endpoint that would lead to mortality, cancer- and disease-specific morbidity and mortality, is ovarian cancer, and everyone knows that the pelvic exam is notoriously bad for detecting ovarian cancer. Furthermore, no one dies from bacterial vaginosis, genital herpes and vaginal trichomoniasis, all of which are treatable (and don’t cause death).
  • Finally, the authors did not recommend changes to current cervical cancer screening guidelines (aka pap smears with or without human papilloma virus (HPV) testing). Since these guidelines DO recommend routine cervical cancer screening, which does require–at a minimum–a vaginal speculum exam (not exactly the same as a pelvic exam), how is one to do this without a routine screening pelvic examination?

So, at the risk of being redundant, I strongly disagree with the conclusion of the USPSTF draft evidence review, but particularly as it applies to postmenopausal women. There is a lot more that goes into the routine gynecological visit, including the pelvic exam. The pelvic exam is needed to screen for conditions such as the genitourinary syndrome of menopause (vaginal atrophy, that affects more than 50% of postmenopausal women), fibroid tumors, abnormal or heavy menstrual bleeding, pelvic floor conditions, and cancers and precancers of the vulva, vagina, cervix and uterus, etc. Not to mention: gonorrhea, chlamydia, syphilis, hepatitis, HIV; spousal, alcohol and drug abuse; menopausal hot flashes and night sweats, sexual dysfunction, among many other conditions.

Missed Opportunities
Broadly, the conclusion to discontinue the routine pelvic exam runs counter to the goals of improving women’s health through preventive care. If pelvic exams are performed only when women complain of problems or have symptoms, we will miss opportunities to diagnose potentially fatal pelvic cancers and other conditions. Being asymptomatic is not the same as being healthy or not having a problem.

Dr. James A. Simon, MD, CCD, NCMP, IF, FACOG


Released July 1, 2016

Under the editorship of NAMS Executive Director JoAnn V. Pinkerton MD, NCMP, First to Know presents commentary on the latest, breaking scientific articles as suggested by members of The North American Menopause Society (NAMS), the leading nonprofit scientific organization dedicated to improving women’s health and quality of life through an understanding of menopause and healthy aging. Opinions expressed in the commentary are not necessarily endorsed by NAMS or by Dr. Pinkerton.

USPSTF looks for public comment on routine pelvic exams draft evidence review

“There is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice.”

Guirguis-Blake JM, Henderson JT, Perdue LA,
Whitlock EP. Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the US Preventive Services Task Force. Evidence Synthesis
No. 147. AHRQ Publication No. 15-05220-EF-1. June 2016.

Summary. The US Preventive Services Task Force (USPSTF) has opened for public comment a draft evidence review on the necessity of annual well-woman pelvic examinations. The final evidence review will be used to inform the first-ever USPSTF recom- mendation statement on pelvic exams.

The USPSTF has pointed out that although some 60 million pelvic exams are done each year, the practice has not been very well studied and said that the current evidence is “insufficient” to determine the balance of benefits and harms of the pelvic exam.

The systematic review was written to support the USPSTF in creating its recommendation on the periodic screening pelvic examination. The authors sought to discover direct evidence for the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease-specific morbidity and mortality, and improving quality of life.

The authors performed a search of the medical literature published over the past 60 years. They located just eight studies looking at the diagnostic accuracy of pelvic exams for only four medical conditions: ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes.

In the four ovarian cancer screening studies, with more than 26,000 women screened, more than 96% of the positive test results were false positives, and many patients had unnecessary follow-up procedures. Surgery rates resulting from an abnormal pelvic examination ranged from 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and 1% complication rate within 1 year.

In the end, the authors found no studies that assessed how effective the exams are for reducing death and disease or improving quality of life.

The draft recommendation does not apply to women who are pregnant or those with existing conditions that need to be evaluated and does not recommend changes to current guidelines for cervical cancer screening.

The American College of Obstetricians and Gynecologists (ACOG) said in a June 28, 2016, statement on the draft recommendations that it continues to recommend an annual pelvic examination for women aged 21 years and older but acknowledges that there is a lack of data. Its Well-Woman Task Force in 2015 recommended annual external exams but said that internal speculum and bimanual exams for women without specific complaints or symptoms should be “a shared, informed decision between the patient and provider.” ACOG is reviewing the draft recommendation to decide whether it needs to update its own pelvic-exam guidelines.

The opportunity for public comment on the draft review evidence expires on July 25, 2016, at 8:00 PM EST. To comment, go to USPSTF draft evidence review.

Commentary. The Executive Committee of The North American Menopause Society (NAMS) strongly disagrees with the conclusion of the USPSTF draft evidence review, particularly as it applies to postmenopausal women. The only four outcome measures available for inclusion in the review—ovarian cancer (for which there is NO good method of detection), bacterial vaginosis, genital herpes and vaginal trichomoniasis—represent a narrow fraction of the key medical conditions screened during the pelvic exam and disregards the many

benefits of the pelvic exam. Although it is perhaps reasonable to recommend against the pelvic exam for diagnosing those four conditions, there is no scientific basis for extrapolating beyond those four specific conditions to the myriad conditions that affect women.

The pelvic exam is needed to screen for conditions such as the genitourinary syndrome of menopause that affects more than 50% of postmenopausal women, neoplasias, fibroids, pelvic floor conditions, and dermatologic conditions associated with elevated disease risks (eg, lichen sclerosis). Broadly, the conclusion to discontinue the exam runs counter to the goals of improving women’s health through preventive care. The recommendation to perform pelvic exams only if women complain of problems will lead to missed opportunities to diagnose pelvic issues. Being asymptomatic is not the same as being healthy or not having a problem. The recommendation to discontinue routine pelvic exams runs the risk of further marginalizing postmenopausal women.

We strongly encourage a call to action to comment on this draft recommendation and to have your voices heard BEFORE women lose their right to routine screening pelvic exams.

The NAMS 2016 Executive Board

JoAnn V. Pinkerton, MD, NCMP, NAMS Executive Director
Peter F. Schnatz, DO, NCMP, NAMS President
Marla Shapiro, MD, NCMP, NAMS President-elect
Pauline M. Maki, PhD, NAMS Past-President
James Liu, MD, NCMP, NAMS Treasurer
Gloria Richard-Davis, MD, FACOG, NAMS Secretary
Sheryl Kingsberg, PhD, NAMS Board Member

First to Know® is a registered trademark of The North American Menopause Society Copyright © 2016 The North American Menopause Society
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glansNo, this post isn’t about penises or vibrators. (Why do our minds always go there!) I’ll reserve that subject for Part 2. This is about the clitoris. Yes, the clitoris, “a small erectile female organ located within the anterior junction of the labia minora that develops from the same embryonic mass of tissue as the penis and is responsive to sexual stimulation” (according to Merriam-Webster on-line dictionary). While seldom the subject of much scientific research, a recent publication* investigated the relationship between clitoral size and sexual function (including the extensive internal portion – “out of sight, out of mind” you might say).

In a small convenience sample of women having a pelvic MRI for other reasons (such as fibroid tumors), these researchers compared clitoral size and each woman’s sexual function as measured by several validated scales. Paradoxically, women with the smallest clitorises (yes, that’s the correct pleural of clitoris), specifically the clitoral body and crus (see diagram below), had the best sexual function. Those women with a smaller clitoris tended to have better desire, arousal, lubrication, and orgasm. The authors of the study suggest that a greater density of nerves, basically squeezing the same number of nerves into a smaller space, is what leads to better function.

There are several limitations to this study, so take these findings with a grain of salt. The relatively few women who participated were having their MRIs done for other medical reasons besides participation in this sexual function study. Therefore, the findings may not actually be generalizable to all women, especially “normal” women without another existing medical condition. But, this study does give a whole new potential meaning to the oft-quoted “good things come in small packages” idea.  And that’s c.o.m.e., not c.u.m! Really, does your mind always go there?

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* Vaccaro CM, Fellner AN, Pauls RN. Female sexual function and the clitoral complex using pelvic MRI assessment. European Journal of Obstetrics & Gynecology and Reproductive Biology 180: 180–185, 2014.


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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Vulvovaginal Atrophy

vulvovaginalVulvovaginal atrophy (VVA) is a common condition associated with the decreased estrogenization of the vaginal tissues. It occurs most often after menopause, but it can also develop during breast-feeding or at any other time your body’s estrogen production declines.

The inevitable estrogen deficiency that accompanies reproductive aging and menopause results in universal changes in the vaginal ecosystem associated with a variety of vulvovaginal and urogenital complaints. At some point in their lives, the majority of women will experience these symptoms, collectively termed the genitourinary syndrome of menopause (GSM), a term which has recently replaced vulvovaginal atrophy (VVA) in the accepted nomenclature. VVA or GSM symptoms usually develop gradually and become most bothersome as women transition to the mid-to-late 50’s. These symptoms typically follow the vasomotor symptoms of menopause, such as hot flashes and night sweats. Unlike VMS, which usually subside after several years, the symptoms of GSM (see below) persist and increase in both frequency and intensity as women age.

With estrogen deficiency, the epithelium (aka the surface cells) of the vagina and vulva thins and loses its rugal folds. Those folds are really important. Think of the difference between a pair of pants with elastic, or a skirt with pleats vs one without. Imagine how you would feel trying to put them on if you’ve gained 20 pounds. Which pants would you like to squeeze into? With menopause and increasing VVA or GSM, the elasticity provided by those rugal folds diminishes, and susceptibility to injury, even with minor trauma, can ensue. Estrogen deficiency also leads to diminished vaginal glycogen and decreased acidity of the vaginal secretions (increased pH), thereby reducing the vagina’s natural defense against local pathogens (i.e. yeast and coliforms [the most common bacteria of fecal material]). The close proximity of the lower urinary tract to fecal contamination is associated with an increased risk for acute and recurrent urethritis and cystitis (bladder infections).

When a woman doesn’t have intercourse or other vaginal sexual activity on a regular basis following menopause, her vagina may also become shorter and narrower. Continuing to have regular vaginal sexual activity through menopause helps keep the vaginal tissues thick and moist and maintains the vagina’s length and width. This can help keep sexual activity pleasurable. This has euphemistically been referred to as “use it or lose it”.

If you do experience vulvovaginal symptoms (dryness, irritation, burning, itchiness, pain) do not automatically assume that reduced estrogen levels are the reason for these symptoms. Because vaginal discomfort can arise from many different sources, persistent symptoms should be brought to the attention of your healthcare provider for evaluation.


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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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Is the FDA Approval of the “Pink Pill” a Probable Outcome?

18jdwo1qlvkujjpgA failure to approve flibanserin would set a dangerous precedent. Why? Because the pharmaceutical company did everything the FDA asked it to do, and the results came out statistically significantly better than placebo—which was the desired endpoint. If the FDA were to deny approval of the drug, it would be saying, in effect, that it can change its mind in the middle of the argument.

In reality, the FDA is likely to say yes to approval, but with restrictions, as that is what its advisory committee recommended. What those restrictions will be remains to be determined, but they are likely to resemble those of other drugs in the class, such as selective serotonin reuptake inhibitors (SSRIs), including a warning to be careful using flibanserin with alcohol until the drug’s effects are clear.


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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 reading “Opposition to the “Pink Pill””

The “Pink Pill”-Who Is It For?

Pink PillsThe “pink pill”, flibanserin, was developed for premenopausal women. Although preliminary data on flibanserin use among postmenopausal women are available, the drug was studied primarily in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), the indication sought at this time.

In the premenopausal population, problems such as pain with intercourse or hyperestrogenism aren’t typically present, simplifying the identification of HSDD. In clinical trials of the drug, HSDD was secondary, generalized, and acquired—that is, it followed a period of normal sexual function. And it didn’t come and go but was present regardless of location and circumstance.

Study participants had had a normal sex drive before their desire “turned off,” an occurrence they found distressing.

Clinicians, myself included, have been frustrated by our inability to prescribe an effective treatment for this common problem. The recent recommendation of an FDA Advisory panel to approve flibanserin for the treatment off HSDD in premenopausal women brings us a step closer to having additional options for treatment.
(Excerpted from an editorial by Dr. James Simon published in OBG Management, July 2015)


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