Public Policy Statements

“The anabolic-androgenic steroids (AAS) are a family of hormones that includes testosterone and its derivatives. These substances have been abused by elite athletes since the 1950s, but their use did not become widespread in the general population until the 1980s. Thus, knowledge of the medical and behavioral effects of illicit AAS use is still evolving.

There is some evidence that the use of AAS may be associated with premature mortality (especially cardiovascular). There is stronger evidence also of suppressed spermatogenesis (which may be irreversible), gynecomastia, and virilization. Behavioral effects of AAS may include hypomanic or manic symptoms, sometimes accompanied by aggression or violence, which usually occur while taking AAS, and depressive symptoms occurring during AAS withdrawal.

The general population, including athletes, should be educated about the adverse events of the widespread use of AAS.”

Counterfeit drugs are a significant threat to public health. In most studies of the content of counterfeit drugs, the counterfeit product does not contain the amount or type of drug claimed by the product packaging. In many cases, the counterfeit drug contains pharmacological or other substances not named by the product’s packaging, some of which are illegal and dangerous. Deaths and serious illnesses have been caused by the presence of unnamed pharmacological products in counterfeit drug products. It is impossible for a patient or a healthcare practitioner to know whether or not the stated content of a counterfeit drug is accurate or whether dangerous substances have been added to a product.

Physicians have a role to play in patient education about counterfeit drugs. Because of the risk of serious illness or death, physicians should warn patients not to use counterfeit drugs of any type. Patients should obtain medications only from a reputable pharmacy. It is unethical for physicians to condone the use of counterfeit drugs, including PDE5-inhibitors, in any circumstances.

Female genital cutting is a widespread practice in some parts of the world. It is usually performed on female infants, children, or pubescent girls under non-sterile conditions without anesthesia. The extent of cutting varies from a small superficial skin cut to removal of the entire external female genitalia. Female genital cutting exposes a female to risk of serious infection and may cause sexual dysfunction, reproductive dysfunction or death from hemorrhage or sepsis. Unlike male circumcision, there are no known health benefits to female genital cutting. Female genital cutting should be condemned in the strongest possible terms and should not be tolerated by any healthcare practitioner, any agency responsible for public health or any government.

Hypoactive sexual desire disorder (HSDD) affects around 10% of women across all age groups. It is defined in both the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV-TR) and the International Classification of Diseases (ICD-10, F52.0). HSDD has deleterious effects upon women’s overall health and/or couples’ well-being. It may cause psychological, emotional and/or relationship distress which, in some cases, is severe and debilitating. HSDD can be a major impediment to life satisfaction and happiness; it should never be considered trivial, unimportant or illusory. HSDD is a medical problem and the healthcare needs resulting from it frequently remain unmet. It deserves greater attention from healthcare professionals across all clinical disciplines.

The International Society for Sexual Medicine (ISSM) believes that:

• Women have the right to sexual well-being and to sexual healthcare, and that sexual well-being includes the opportunity for women to experience sexual intimacy and pleasure.
• Women should have the right to have their concerns regarding their sexual well-being assessed and treated by the healthcare professional of their choice.
• Women should have the right to choose whether or not to use evidence-based medical, psychological and behavioural interventions, either individually or in combination, as they, and their health professional advisers, agree is most appropriate to their individual circumstances.

These are individual rights and they should be available to all women, to enable them to make individual and personal choices about their sexual well-being and sexual healthcare.

The specific biological basis of HSDD, like that of depression, is the subject of ongoing scientific research.
However, there is already ample evidence that physiological, psychological and socio-cultural factors may all play important roles. ISSM strongly encourages research into HSDD, and the development of effective therapeutic interventions for this common and distressing condition.

“In recent years, many articles have appeared in the literature that have examined the relationship between male circumcision status and the risk of contracting human immunodeficiency virus (HIV) infection.
Despite some limitations in evidence and in well-controlled studies, the evidence that does exists, suggests circumcision may reduce the risk of heterosexually acquired HIV infection in men by approximately 60%. However it is insufficient to recommend male circumcision to control HIV infection and transmission. More studies would be necessary before a recommendation for circumcision could be made.

Rather than advocating universal circumcision, circumcision can be considered in targeted populations and moreover, it would be more appropriate to advocate better public health education.”

It is important to point out that HIV can be prevented through several known very effective means, such as condom use, limiting exposure to multiple partners and 'pre-exposure prophylaxis’ for high risk populations."

Premature ejaculation is a common sexual problem that may have a significant negative effect upon an individual’s or a couple’s well-being. It may cause psychological, emotional and relationship distress, which in some cases is severe. It is a sexual health issue that may impair the well-being of both the affected man and his partner; it should not be considered trivial or unimportant.

The causes of premature ejaculation have not been definitively identified, but there is robust evidence that genetic and physiological factors are important in some affected men. In some men, psychological and relationship factors may also play an important role.

Men should be able to have their concerns regarding premature ejaculation evaluated and treated by healthcare professionals with medical, psychological, and behavioral interventions, used individually or in combination, as patient and professional agree is most appropriate.

As a professional society dedicated to the effective and safe treatment of individuals with sexual dysfunction and men’s health overall, the International Society for Sexual Medicine is aware of recent concerns regarding cardiovascular risks associated with the use of testosterone therapy. This concern stems from two journal articles, one published in November 2013 in the Journal of the American Medical Association (1), and the other published in January 2014 in the journal, Plos One (2). Neither of these reports was a planned experimental study with control groups and defined goals. Instead these were retrospective analyses of data collected for other reasons. These types of analyses are prone to bias and error, and results are often irreproducible (3). For this reason, this type of study is generally not used for medical decision-making, although in some cases these may prompt further investigation with an experimental study.

Review of both studies (click here for detailed analysis of these studies) reveals major flaws that render questionable the assertion that testosterone therapy increased cardiovascular (CV) risks. The suggestion of increased cardiovascular risk with these recent reports is contradicted by a large body of literature that strongly indicates CV risks in association with low testosterone levels, and beneficial effects of T therapy in improving risk factors for CV disease (4-7). Although an objective scientific approach must openly consider all new evidence, the ISSM does not find these new reports to provide credible evidence of increased CV risk with Testosterone therapy.

Testosterone deficiency (also called hypogonadism) is a medical condition recognized for over a century, associated with symptoms that include reduced sexual desire, erectile dysfunction, fatigue, depressed mood, reduced muscle mass, and increased fat. Research has shown that testosteronedeficiency is also associated with a number of significant health issues, such as diabetes, obesity, the metabolic syndrome, and bone fractures (6). Several longitudinal population-based studies have demonstrated reduced longevity in men with low testosterone levels (8-11). Treatment of testosterone deficiency improves symptoms as well as several indicators of general health. Testosterone therapy is only indicated in men with characteristic symptoms or signs as well as documented low testosterone levels.

Like all treatments, Testosterone therapy has risks (12). The most common are erythrocytosis (increased production of red blood cells), acne, gynecomastia (breast enlargement), and fluid retention. Clinical and biochemical mornitroing should be undertaken. The historical concern that Testosterone therapy promotes prostate cancer appears to be unfounded (13). The current evidence does not support the assertion that Testosterone therapy increases the risk of heart attacks, stroke, or other cardiovascular risks.

Recommendations

There is no reason to change the current management of men with testosterone deficiency on the basis of these recent articles. Men currently being treated for testosterone deficiency with testosterone therapy and experiencing benefits may continue treatment. Men diagnosed with testosterone deficiency should consider treatment with testosterone therapy after full discussion with their healthcare provider. Testosterone therapy for hypogonadal males provides significant benefits for men with sexual symptoms, and also for a variety of non-sexual symptoms. Like all medical treatments, testosterone therapy is associated with risks, and these should be discussed with one’s healthcare provider. Weighing the entirety of available medical research, there is no compelling evidence that testosterone therapy increases cardiovascular risks.

References

1. Vigen R, O’Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310:1829-1836.
2. Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni Jr JF, Hoover RN. Increasing Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e85805. Doi: 10.1371/journal.pone.0085805
3. Ioannidis, J. P. A. Contradicted and initially stronger effects in highly cited clinical research. Journal of the American Medical Association, 2005; 294, 218–228.
4. Oskui PM, French WJ, Herring MJ, Mayeda GS, Burstein S, Kloner RA. Testosterone and the cardiovascular system: a comprehensive review of the clinical literature. J Am Heart Assoc. 2013 Nov 15;2(6):e000272
5. Carson CC and Rosano G. Exogenous testosterone, cardiovascular events, and cardiovascular risk factors in elderly men: A review of trial data. J Sex Med 2012;9:54–67.
6. Traish AM, Miner M, Zitzmann M, Morgentaler A. Testosterone deficiency. Am J Medicine, 124, 578-587, 2011.
7. Aversa A, Bruzziches R, Francomano D, Rosano G, Isidori AM, Lenzi A, and Spera G. Effects of testosterone undecanoate on cardiovascular risk factors and atherosclerosis in middleaged men with late onset hypogonadism and metabolic syndrome: Results from a 24-month, randomized, double-blind, placebo-controlled study. J Sex Med 2010;7:3495–3503.
8. Shores MM, Matsumoto AM, Sloan KL, Kivlahan DR. Low serum testosterone and mortality in male veterans. Arch Intern Med. 2006;166:1660–1665.
9. Laughlin GA, Barrett-Connor E, Bergstrom J. Low serum testosterone and mortality in older men. J Clin Endocrinol Metab. 2008;93:68–75.
10. Khaw KT, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Day N. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007;116:2694–2701.
11. Haring R, Volzke H, Steveling A, Krebs A, Felix SB, Schofl C, Dorr M, Nauck M, Wallaschofski H. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20-79. Eur Heart J. 2010;31:1494–1501.
12. Rhoden EL, Morgentaler A: Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med 350:482-92, 2004.
13. Khera M, Crawford D, Morales A, Salonia A, Morgentaler A. A New Era of Testosterone and Prostate Cancer: From Physiology to Clinical Implications. Eur Urol. Epub 2013 Aug 16.