International Society for the Study of Women's Sexual Health

ISSWSH Executive Committee responds to CNN Health Article

A recently published health report on HSDD treatments was poorly researched, contained elements of bias, and perpetuated inaccuracies about the condition.

We, the Executive Committee of the International Society for the Study of Women’s Sexual Health (www.isswsh.org) write this response to an article published on May 8, 2019 on CNN Health entitled “Drug Campaign Touts 'Female Viagra' in the Name of Equality” by Rachel Bluth of Kaiser Health News (https://edition.cnn.com/2019/05/08/health/women-libido-addyi-partner/index.html).  As a scientific and medical society dedicated to supporting research, education, and clinical care for women’s sexual health, ISSWSH encourages informed discussion on disease states impacting sexual health.  We also understand that there may be valid critiques of how some pharmaceutical companies conduct their marketing campaigns.  Nevertheless, we found the article in question to be poorly researched and especially biased.

 

In particular, the opinions of four analysts who currently serve in leadership positions at health policy and advocacy organizations were expressed but not a single sexual medicine expert was consulted.  Despite CNN’s reputation as a trustworthy news organization, this particular health report was poorly researched and perpetuated inaccuracies about the condition of HSDD, as well as available treatment options.  We provide below additional clarification on some of the issues that we noted were lacking perspective, leading to false impressions.

  1. Article perpetuates inaccuracies or misunderstandings about HSDD:
  • “Studies have never defined a ‘normal’ level of sexual desire.’

Normative ranges for sexual desire are defined by each individual and persistent changes in this level of sexual desire that are sufficient to cause personal distress can result in the condition of acquired, generalized HSDD.  By definition, this condition cannot be diagnosed if the decline in sexual desire is caused by a poor relationship, medications or another medical/psychiatric condition.  Thus, the lack of a quantitative definition of normal sexual desire for the general population is inconsequential for the diagnosis and treatment of HSDD.

  • “…doctors recognize that there is (perhaps) a condition called Hypoactive Sexual Desire Disorder…”

The existence of HSDD is not in question.  HSDD has been recognized as a diagnosable disorder by the American Psychiatric Association for over 30 years and is identified as a distinct medical condition by the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization (WHO).  The specifics in the definition of HSDD have been revised over the years as we learn more about the condition but this is no different from cancer, depression, heart disease, diabetes or any other disease state, as scientists and clinicians have developed their understanding and improved treatment options.

  • “…doctors on the 2016 consensus panel that defined HSDD…”

This is in reference to an expert consensus panel convened by the International Society for Women’s Sexual Health and its deliberations that subsequently resulted in a peer-reviewed publication in a highly respected and widely read medical journal (Mayo Clinic Proceedings).  This panel reviewed the state of the field and available treatments for HSDD.  It did NOT define HSDD, which (as previously mentioned) has been recognized as a diagnosable disorder for over 30 years.

  • “And, for those who would simply like a little more sex in their lives, is it worth a $400-a-month pill?”

This statement entirely misrepresents the chronic condition of HSDD that has been associated with clinically significant personal distress that includes frustration, grief, incompetence, loss, sadness, sorrow, worry, impaired body image, and decreased self-confidence and self-worth.  The level of personal burden has been estimated to be comparable to diseases such as diabetes and chronic back pain.  Participants in the pivotal clinical trials for flibanserin were in stable relationships with a mean duration of approximately 10 years and identified having HSDD for half that time.  Patients with HSDD are not looking for “a little more sex”.  They are looking to regain their previous sexual health norm.

  • “It's difficult to pinpoint the number of women who report a persistent lack of sexual desire..”

Lack of sexual desire or low desire by itself does not constitute HSDD and studies and surveys have indeed reported varying data, depending on methodology.  A key criterion is that a person must have associated personal distress due to this condition.  Several epidemiological studies on HSDD conducted by noted academic researchers that include distress have been published and identify a prevalence for HSDD ranging from 6 – 19%, a much narrower range than simply low sexual desire.

  • “Experts say it's difficult to get an accurate picture of the problem medically known as low libido because it has so many possible causes -- depression, poor body image, fatigue, stress, pregnancy and menopause. Even in the Sprout-sponsored study, many women who were distressed about their low sexual desire ascribed it to ‘relationship issues.’ ”

“Low libido” is certainly a generalized and ill-defined term that can be attributed to many different factors.  However, in clinical trials evaluating flibanserin, patients had to be diagnosed with the medical condition of HSDD.  Patients could not be diagnosed with HSDD if the cause of their condition was primarily attributed to “relationship issues”.  Relationship issues arising secondarily to the onset of HSDD is an entirely different matter.  Further, it is not clear to what “Sprout-sponsored study” the reporter is referring.  The major trials submitted to the FDA in evaluating flibanserin’s efficacy and safety were actually conducted by Boehringer Ingelheim, the original developer of flibanserin.

  1. Article perpetuates inaccuracies or misunderstandings about the efficacy and safety of Addyi (flibanserin):
  • “[Addyi]… should not have been approved by the FDA…and it is not a product that adds value to women’s lives.”

These opinions were expressed by Dr. Susan Wood who is identified as a former Assistant Commissioner for Women’s Health at the FDA.  However, as noted in the article, Dr. Wood left the FDA in 2005, well before the submission of flibanserin’s new drug application in 2009 and clearly did not participate in evaluating flibanserin.  While she is entitled to her opinions, the FDA did ultimately rule that the benefits outweigh the risks for flibanserin.  Whether a given therapy adds value to one’s life is up to the individuals impacted by the condition and cannot be determined by an outside observer.

  • “…in the studies that led to Addyi’s approval, results were not terribly impressive.” “Even during drug trials, Addyi's effectiveness was questioned. On average, women who took it reported one increased sexually gratifying experience every other month, and that was only after the subjects began recording their experiences monthly instead of daily.”

While “sexually satisfying experiences” were included as an endpoint in the clinical trials, this is not a characteristic of HSDD and is not relevant to the diagnosis of this condition.  This was an endpoint imposed by the FDA and a carryover from previous experience with drugs intended to treat erectile dysfunction in men.  Much more relevant to HSDD is a decrease in sexual desire that causes personal distress.  On average, flibanserin consistently demonstrated statistically significant and clinically meaningful increases in sexual desire and decreases in associated distress.  The monthly assessment of sexual desire was accomplished using a thoroughly validated and internationally accepted instrument called the Female Sexual Function Index (FSFI) and was included in all the clinical trials assessing flibanserin’s efficacy as part of their original plan and design.  Unfortunately, the FDA did not appropriately understand the nature of sexual desire and its assessment and imposed a non-validated electronic daily diary to assess sexual desire during the first two pivotal trials and required that the developer of flibanserin use this as a primary endpoint.  The persistent daily questioning about the patients’ sexual desire caused response fatigue and significant data dropout and made interpretation of the diary data problematic.  Nevertheless, amongst patients who did report benefit in the clinical trials, flibanserin therapy resulted in a 2 – 2.5-fold greater magnitude of improvement over baseline in sexual desire, distress and even sexually satisfying events when compared to the overall study group.

  • “There are also concerns about side effects like dangerously low blood pressure, fainting, severe drowsiness and insomnia.”

All medications have the potential to cause adverse events and, as acknowledged by the FDA itself, many FDA-approved drugs besides flibanserin cause central nervous system depression, leading to symptoms like low blood pressure, fainting and drowsiness.  The FDA stated that the risks of flibanserin can be adequately managed with appropriate labeling.  In fact, much of the side effects are mitigated by the recommended bedtime dosing of flibanserin and the frequency of side effects decreases with continued use.  In the clinical trials, 0.5% of patients experienced syncope (a temporary loss of consciousness caused by a fall in blood pressure) while taking flibanserin and 0.3% of patients experienced syncope while taking placebo.  These rates between active drug and placebo are considered to be low and not readily distinguishable from each other.  Of greater importance were more prevalent symptoms of dizziness, somnolence and nausea, each experienced by less than 12% of patients taking flibanserin and mostly mild to moderate in intensity.  Again, these were mitigated by flibanserin’s bedtime dosing.

The ISSWSH Executive Committee

James A. Simon, MD, CCD, NCMP, IF, FACOG - President
Noel N. Kim, PhD, IF - President-Elect
Brooke Faught, DNP, WHNP-BC, NCMP, IF - Secretary
Alyse M. Kelly-Jones, MD, IF, FACOG - Treasurer
Irwin Goldstein, MD, IF - Immediate Past President

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