Michael A. Perelman1, 2, 3
(1)
Reproductive Medicine and Urology, Weill Medical College Cornell University, 70 East 77th Street, New York, NY 10075, USA
(2)
Human Sexuality Program, The New York Presbyterian Hospital, New York, NY, USA
(3)
MAP Education and Research Fund, New York, NY, USA
Michael A. PerelmanPsychiatry, Co-Director, Founder
Email: michael@mapedfund.org
Keywords
EpilogueFutureTransdisciplinary sexual medicine
Sexuality , with its fundamental connection to reproduction, has been the subject of sustained and inordinate interest among all cultures since prehistoric ages. Sexual dysfunctions have been experienced as devastating problems to mankind since the beginning of recorded time, evidenced by Stone Age wall paintings and biblical references. The material contained in this volume’s previous pages support sexual medicine as a postmodern, twenty-first-century solution to that prebiblical problem [1].
One cannot be anything but excited and extremely optimistic in the face of the huge progress made in the last two decades since the sildenafil clinical trials’ success catalyzed a worldwide expansion of a sexual medicine subspecialty and simultaneously revitalized sex therapy1 [2]. Given the advances in our knowledge about desire, arousal, ejaculation, and orgasm in women and men, there is no doubt that we will provide more optimal care for those suffering from the consequences of sexual disorders in the future by integrating appropriate use of medical and surgical techniques with adequate counseling.
The degree of advancement in our neurobiological, molecular, and genetic understanding of the mechanisms of sexual function and dysfunction at both the central and peripheral levels is extraordinary. There is no indication that this pace will slow down, and fortunately there is every indication that the rate at which we are accumulating such knowledge is accelerating. We are developing new pharmaceuticals for sexual indications at a speed unimaginable over 50 years ago when Masters and Johnson first published Human Sexual Inadequacy [3]. New technologies are in place as described in the Le and Burnett chapter to improve our treatments of erectile dysfunction. There is no drug approved for delayed ejaculation yet (nor is one in clinical trial at the time of this writing). However, there are a number of treatments for premature ejaculation that are being investigated and/or awaiting regulatory approval. The rapid advancement and use of novel, contemporary techniques in our ability to study animal models and patients with localized brain lesions provide much of our understanding about the neuroanatomical and biochemical pathways important for ejaculation and orgasm. With the emergence of noninvasive techniques including molecular-level resolution brain imaging and genetic analysis, there are opportunities to strengthen our current understanding and identify new central pathways that will lead to improved therapies for both men and women. Yet, there are potential downsides, which remain a source of concern for the professionalism and further maturation of our field.
35.1 Lack of a Sexual Health Formulary for Women
The lack of a robust sexual health formulary for women, particularly when juxtaposed against the number of products available for men, has been decried for years. In fact, the 2003 International Consultation held in Paris was a highly regarded professional milestone in the history of sexual medicine, in part because of the infamous debate on this topic between the English cardiologist Graham Jackson and the American psychologist Leonore Tiefer. Collaboration between major urology, sexual medicine, and sex therapy associations led to the assembly of more than 200 multidisciplinary experts (male and female) from five continents and 60 countries into 19 committees. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine areas represented expert opinion developed over 2 years. This achievement reflected tremendous rebalancing of sexual medicine into a multidisciplinary movement [1]. Jackson and Tiefer debated whether “FSD was a construction of the pharmaceutical industry,” the heart of public and professional concerns about the pharmaceuticalization and medicalization of sexual health in general and female sexual health specifically. The fine point was not whether women had sexual concerns and issues, but how they were defined, what gave rise to them, and what type of treatment (or not) they required. The US Food and Drug Administration’s (FDA) failure to have approved a sex drug for women added much to the drama and legend.
Embedded for some was a “gender story” of a perceived overemphasis on male erection within the sexual medicine movement and a simultaneously held fear and concern regarding the commercialization of women’s sexual complaints. Tiefer advocated a “new view of women’s sexuality,” [4] a collaborative grass roots effort of academic social scientists, therapists, and women’s health activists. The audience declared Jackson the “winner,” but Tiefer was ensconced as the iconic standard bearer of the “new view.”
However, the situation for women is poised for improvement. In 2014, the FDA conducted a 2-day Patient-Focused Drug Development public meeting and scientific workshop on FSD. On day 1, the FDA was interested in obtaining patient input on the impact of the most common form of FSD, female sexual interest/arousal disorder (FSIAD ) on daily life. In addition, the agency wanted to obtain patients’ and some partners’ views on currently available therapies to treat the condition. During the second day’s workshop, the FDA facilitated discussions of the scientific challenges related to diagnosing the condition in both clinical trials and practice. There was further discussion about the importance of ensuring valid patient-reported outcome measures for the key efficacy end points used in clinical trials. Subsequent to that meeting, Sprout Pharmaceuticals resubmitted a new drug application (NDA ) to the FDA for flibanserin, an investigational, once-daily, nonhormonal pill for hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, flibanserin would be the first and only FDA-approved treatment for any FSD.2 Should that drug obtain regulatory approval, there is little doubt such success would be a watershed event that would trigger increased commercial funding for sex research and the next generation of sexual pharmaceuticals.
Whether one is for approval or not, the implications for sexual medicine and the public at large will be profound. Yet, that meeting, like so many other issues in sexual medicine, was almost overwhelmed with controversy. Why?
35.2 Medicalization and Pharmaceuticalization
There are many reasons, but two are especially important, both the fear of medicalization and its related worry of pharmaceuticalization of normal variations of human sexual response. In part, this was a continuation of a century-old debate pitting reductionism against holism. The majority of professional societies concerned with the consequences of the FDA meeting supported the view that women should be offered the individual choice and opportunity to determine, with their healthcare professionals, what type of treatment would be best suited to help relieve their individual suffering. Other professionals and representatives of some women’s organizations felt that flibanserin was insufficiently studied at that time to warrant approval, and they urged that the FDA should merely encourage the pursuit of more scientific knowledge about FSD. The debate about flibanserin is an important one in the history of sexual medicine, and the FDA meeting was a turning point regardless of the side one took. Yet, hidden within that conflict was another.
35.3 Who Are the Experts?
“Who are the experts” is one of the most important controversies dividing and perhaps defining the field of sexual medicine today. This important question determines who treats the problems, the nature of research, and how all is conceptualized. Throughout this book, those issues have been discussed both directly and at other times only tangentially and implicitly. Different healthcare specialists significantly and consistently reflect profession-of-origin bias. Some of those biases were offset in this book by the commentaries, allowing the readers to comprehend for themselves how to integrate the biological and psychosocial-behavioral and cultural components with sexual dysfunction diagnosis and treatment. Hopefully, this text laid the foundation for such integration, but inevitably a few oversimplifications appear within it. Yet, such lapses might be expected in a volume of this length, breadth, and depth. Generally, the mental health experts emphasized the importance of a biopsychosocial approach, often recognizing humanistic values. The urologists tended to emphasize better understanding of physiology, improved surgical techniques, new drugs to improve performance, and protocols for a variety of male-related illnesses and treatments with known sexual sequelae. Gynecologists emphasized the growing body of knowledge gained in understanding female sexual physiology, diagnosis, and treatments. All of the experts explicitly (or implicitly through citation) recognized the importance of the relatively recent emergence of sexual medicine professional societies (focused on men, women, or both) and the rise of learned journals devoted to this nascent specialization. So what is the problem, and what still remains a concern?
While the mission of this book is to advocate for a transdisciplinary approach where expertise is integrated for the benefit of the field and patients, not all stakeholders view sexual issues in the same light. Regrettably, many professionals continue to be unduly influenced by reports from some patients who previously had consulted with reportedly incompetent and judgmental sexual medicine practitioners, as well as sex therapists. Such experiences led them to seek interventions from practitioners of another discipline and to reject contact with members of the offending discipline. Moser [5] listed additional reasons for discord between disciplines: fears that another practitioner will “steal” their patients, mistrust of and/or disbelief in the other’s approach, distrust of the other’s motivation (e.g., beliefs that physicians are bought off by pharmaceutical companies and therapists are anti-physician), and fears that the other discipline will inordinately influence one’s approach undesirably. It is to our field’s detriment that few sex therapists attend conferences focusing on the latest advances in sexual medicine, and still fewer sexual medicine practitioners attend conferences focusing on the latest developments in sex therapy [1, 5].
Additionally, some mental health practitioners remain concerned whether or not sexual medicine as a profession will avoid falling again into the reductionist trap that characterized it from the 1980s through the beginning of the this new millennium. By 1984, our improved ability to diagnose organic pathology with sophisticated assessment devices led to a dramatic increase in the number of men undergoing surgical penile prosthesis placement. Why? Besides sex therapy , the primary treatment available to physicians at that time was surgery. There was substantial evidence that primary care physicians were becoming reluctant to refer cases for sex therapy, as the numbers of men with documented organic deficits increased. Yet, some of those deficits were minor and mirrored deficits found in the general population of men who were still able to function. Some men with ED experienced minor organic deficits escalating into very severe ED because of psychological and relational issues. Yet, frequently, the only solution offered by urologists in that presexual pharmaceutical era was surgery. Of course, the etiology of ED had not changed (it was always mental and physical), but the medical profession’s and the lay public’s outlook had shifted dramatically [1, 6].
Almost overnight, it seemed sexual disorders that were once considered a psychological problem were conceptualized as “purely a physical problem that required a medical solution.” Initially, this was good for our field, as the 75-year emphasis from Freud through Masters and Johnson supporting a primarily psychological determination of sexual disorders had for too long overshadowed the biological factors that were proven to play such an important role. However, more rapidly than most mental health professionals could possibly imagine, that pendulum swung too far in the opposite direction. Was it really true, as many physicians then claimed in lectures and to the media, that “overwhelmingly 90 % of a sexual disorder’s etiology was organic in origin?” Were there not alternative explanations and contributory factors, and if so, why were they not mentioned? The answer is an easy one: modern media and pharmaceutical marketing!
35.4 Modern Media and Marketing
Physician “thought leaders” who consulted to pharmaceutical companies were giving media interviews, arranged and facilitated by the public relations and marketing departments of the pharmaceutical companies who were manufacturing the most popularly prescribed vasoactive drugs and prostheses. Ironically, the very success of the medicalization of sexual concerns at that time also nurtured most of the public and professional controversies that surround the pharmaceutical treatment of sexual problems through today.
For a drug to receive FDA approval, there must be a “disease” that the drug addresses. For men in 1998, for instance, the branded disease du jour was “ED,” and the drug was sildenafil. Furthermore, for a drug to receive acceptance in the medical community, an understandable narrative about its mechanism of action and evidence-based research supporting its efficacy and safety are all required. Tens of millions of dollars were spent proving that drugs do indeed successfully treat male erectile dysfunction. The vasoactive injectables were first, shortly followed by the same class of medication with a transurethral delivery system. Both were “safe and effective.” However, they began to be abused and were later advertised as an easily available treatment for both ED and premature ejaculation (PE) often regardless of the actual etiology of the disorder [7]. These medical treatments and the PDE5 inhibitors (PDE5i’s) that followed years later became the ubiquitous solution offered for any male sexual difficulty. Many found it cavalier and excessive that PDE5is were being overprescribed for every case of ED and other male sexual dysfunctions regardless of the diagnosis and the dysfunction’s level of severity or its etiology.
Dismissed from public discourse and all but forgotten was the truism that every sexual disorder regardless of the severity of its organic etiology also has a psychosocial component: if not a causative one, certainly a consequence [6]. The media had a strong hand in this sea change, although those same promotions did usefully help open a dialogue between the public and the medical community about all aspects of human sexuality. However, nothing has changed the sexual landscape more than the anonymity and openness of the Internet [8]. Prior to the sildenafil launch, telecommunications and the Internet meaningfully amplified the controversy surrounding President Clinton’s affair. In fact, the introduction of sildenafil, combined with the public investigation of President Clinton’s extramarital behavior, changed the nature of polite discourse in the USA, if not the world [1]. What was once a private discussion between a man and his physician (or therapist) had become very public, replete with late-night television comedian commentary. The global media coverage of new techniques for restoring male sexual function was astounding, albeit often overly simplistic. The number of people reached was extraordinary. It became axiomatic in commercials and media interviews that “ED” was a disease you should discuss with your doctor. The exaggerated notion that psychological problems caused most sexual problems was replaced by the equally fallacious argument that sexual problems were the result almost exclusively of organic causes.
Many sex therapists were concerned that they would no longer have a viable role in the treatment of male ED. Many feared the medicalization of human sexuality that Tiefer had warned of years earlier would severely curtail their roles and access to patients [9]. McCarthy noted: “Some physicians and many in the media believe the introduction of sildenafil (Viagra™) is the death knell for sex therapy, at least with males [10].” The hyperbole was profound with some predicting that sex therapists would “soon become extinct, like dinosaurs” [1]. However, to paraphrase Mark Twain, early reports of our demise were greatly exaggerated [2].
All learned that men’s desire for sex, the efficacy of PDE5i’s, and men’s interest in using them (also true for the vasoactive medications for penile injection therapy now used primarily for recalcitrant cases) could be adversely undermined by psychosocial-behavioral and cultural factors. Discontinuation rates as high as 50–60 % were reported in the literature, and greater emphasis and re-interest in relational and other psychological issues emerged within the sexual medicine and pharmaceutical communities [1, 11].
This all becomes particularly important in light of the transdisciplinary message articulated at the beginning of this book. It took the next 10 years for sex therapists and a few very knowledgeable urologists who specialized in sexual medicine to begin reshaping our understanding of etiology to one that had a better balance of both organic and psychogenic factors, e.g., “discontinuation issues” were not only caused by adverse events. These specialists brought to the understanding of sexual medicine the recognition that a binary, “is it organic or psychogenic?” is not the right question to be asked. Instead, one should be searching to identify the various underlying factors and try to determine their relative contributions. Etiology is almost always both mental and physical, but in varying proportions for every case of sexual dysfunction. Any other answer is usually a naive oversimplification.
Ironically though, it was the same pharmaceutical companies that had helped to exacerbate the problem that helped reverse the trend toward an overemphasis on the role of organicity. How? By the new millennium, Pharma had hired sex therapists as consultants to their advisory boards and put them on their speaker bureaus, in order to add a psychological balance to the sexual medicine equation. Funded by unrestricted educational grants, sex therapists spoke at medical meetings about sex coaching for physicians [12].3 Pharmaceutical companies began looking at “partner issues” as relationship context emerged as a major factor in how successfully and continuously their Pharma’s drugs were used [13]. This led to the involvement of more female experts in sexual medicine who encouraged companies to also explore treatments for female sexual disorders. Pharma had initially funded ED epidemiological studies and later investigated the prevalence of other male sexual disorders. The sociologists, epidemiologists, and sexual medicine specialists who designed, ran, and analyzed those studies soon recognized and documented that women had as many, if not more, sexual problems than men [14]. This led to more research on women’s sexual physiology, psychology, and treatments for their sexual dysfunctions as well as their inclusion in the leadership hierarchy of the 3rd International Consultation on Sexual Medicine (ICSM) mentioned earlier in this chapter, as well as the 2015 4th ICSM held in Madrid. By that time, the names and missions of the sexual medicine societies had expanded, including the International Society for Sexual Medicine (formerly the International Society for Impotence Research) and the 2001 formation of the International Society for the Study of Women’s Sexual Health (ISSWSH). Journal mastheads brimmed with names of female sexual health experts, and journal content was expanded to focus on both male and female issues, as well as multiple treatment formats.
Whether Pharma’s motivation was an altruistic search for a true understanding of sexual response across gender and culture for the benefit of mankind, or more cynically to identify and effectively secure and develop new markets, is a debate for others, although even that question is probably too binary and reflects the political and economic beliefs of those who choose to argue it. The result, however, was clear. Sexual medicine expanded and became more diverse and sophisticated. Urological and male hegemony was reduced. In fact, pharmaceutical companies again had a role as their drug “detail reps” (duplicating the marketing plan of SSRIs decades earlier) targeted primary care physicians and subsequently they, not urologists, became the largest prescribing cohort. So if journal editorships, reviewers, authors, presenters, and societies were now gender diverse and multidisciplinary, what is the concern?
35.5 We Are Once Again at a Crossroad
The aforementioned rebalancing took over two decades, but we are once again at a crossroad. Basic and early-stage clinical research using new investigative techniques including molecular imaging and genetic analysis will deepen our understanding of the biological underpinnings of sexual function and dysfunction. Such analysis uses sophisticated techniques that include, among others, whole-genome sequencing, neuroimaging with PET and fMRI studies, as well as better-quality plethysmography and thermography. Precision medicine and nanotechnology represent exciting trends and are some of the most interesting concepts of the day. But an influx of new biological discovery risks returns us to the unnecessary binary thinking that characterized the late twentieth century where many health professionals advocated an outdated, dichotomous, simplistic, etiological model of “organic versus psychological.”
The increasingly contentious role of science and technology in modern society has given rise to controversies that often have profound social, political, and economic implications, and more and more often they feature public disagreements among scientific, technical, or medical experts [15]. What is the alternative to a back-to-the-future rush to overly reductionist thinking and an unnecessary binary view of the mental and physical? How can science advance and make the best use of the tremendous new opportunities that advanced technology makes available to creative and passionate investigators and clinicians? The answer lies in a transdisciplinary approach to sexual medicine.
We are on the cusp of being able to explain some of the varied findings that support and explain both the biological and psychological. We are actually coming closer to resolving the mind-body conundrum that has plagued philosophers for centuries.
For instance, there are new studies demonstrating that some elements of sexual response involve deactivation in areas throughout the prefrontal cortex, a region critical for higher-order functions that include, but are not limited to, both self-control and working memory [16]. Perhaps these data will identify biological correlates of the “spectatoring” phenomena described by Masters and Johnson as one of the most common causes of sexual dysfunction. Perhaps those with particular biological predispositions toward negative ruminative thinking could be identified. The Sexual Tipping Point® (STP) model could illustrate how minimizing such critical distraction with mindfulness or overriding it with erotic fantasy would offset the deleterious effect. In much the same way, the STP model could illustrate how a pharmaceutical could improve sexual response by lowering thresholds for excitement or increase the threshold that triggers sexual inhibition.4 Greater enlightenment will be found within such integrated thinking.
35.6 Maintaining a Transdisciplinary Viewpoint Is a Critical Next Step
This book provides a springboard toward a transdisciplinary sexual medicine perspective for the reader wishing to integrate the lessons implicitly and explicitly offered. The future for sexual medicine does indeed seem bright. Yet, despite sexual medicine’s impressive developments over the past 25 years, sexual worries, disorders, and dysfunctions not only remain with us but may also be increasing because of the problems caused by an ever-escalating saturation of society with sexual images and themes. The introduction of sildenafil foreshadowed a pharmaceutical and biotechnological revolution in the treatment of both male and female sexual dysfunction. As new drugs are developed and approved for men and women, opportunities for educating and assisting people in restoring sexual functioning will only increase. However, sex remains a highly emotionally charged act that always takes place within a psychological and cultural context. As such, sex therapists and physicians working together will continually have an opportunity and responsibility to participate in the restoration of their patients’ sexual health. Yet, the goal of our work is not just to alleviate our patient’s sexual symptom, but is also to improve their intimate relational lives. Our aspiration is for all healthcare practitioners to maintain a patient-centered holistic approach that integrates a variety of treatments as needed, whether for sexual concerns, disorders, or dysfunctions.
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Footnotes
1
While some referrals for ED were lost to mental health professionals, contrary to media hype, the introduction of sildenafil expanded opportunities for sex therapists. Sex therapy was reinvigorated with a new treatment tool, which expanded the number and range of individuals who could be restored to sexual health.
2
2On August 18, 2015 the U.S. Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, but with risk evaluation and mitigation strategies (REMS) required. “Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER) adding, “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies.”
3
Sex therapists have expanded their impact through public and colleague education. In terms of public education, media exposure broadened the scope, range, and size of the general audience who heard a sex therapy message integrated into open discussion. There was unprecedented opportunity with colleague education to reach non-sex therapy professionals with a psychological message. Primary care physicians and urologists learned that incorporating sex therapy techniques improved the effectiveness of sildenafil. Furthermore, sex therapists discovered that integrating adjunctive use of sildenafil with sex therapy accelerated the therapy process and improved outcome.
4
The STP model is a registered trademark of the MAP Education and Research Fund, a 501(c)(3) public charity. STP illustrations are available free from mapedfund.org.