Irrational Exuberance in Testosterone Prescribing

Handelsman, David J.

doi:10.1097/mlr.0000000000000416

Cited by 19 publications

(8 citation statements)

References 21 publications

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“…The promotion of testosterone prescribing has been driven by a classical disease mongering whereby the boundaries of a disease are stretched to vastly expand sales of treatments . For testosterone, this involved re‐defining the term “hypogonadism”, long equated with pathological disorders of the reproductive system, whereby it was stretched to encompass a conjunction of ubiquitous, nonspecific symptoms coupled with a low blood testosterone . Pivotal in this process were the clinical guidelines of the US Endocrine Society, originally published in 2006 and republished unchanged in 2010 which were not pharma‐sponsored although some guideline panel members had dualities of interest with pharma.…”

Section: Discussionmentioning

confidence: 99%

Pharmacoepidemiology of testosterone: Curbing off‐label prescribing

Handelsman

2017

Pharmacoepidemiology and Drug

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Section: Discussionmentioning

confidence: 99%

Pharmacoepidemiology of testosterone: Curbing off‐label prescribing

Handelsman

2017

Pharmacoepidemiology and Drug

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“…Potential contributors to this overprescribing of testosterone include commercial advertising and lax definition of Bhypogonadism^by some society guidelines that fails to distinguish between true pathological hypogonadism (for which testosterone therapy is approved) and the mere presence of low testosterone levels. 10 A public health campaign may be necessary to counteract such advertising, correct such deficiencies in treatment guidelines, and improve prescribing.…”

Section: Discussionmentioning

confidence: 99%

“…9 Putative contributors to this growth in the US include the direct-to-consumer marketing of testosterone products, along with the failure of some professional society guidelines to distinguish age-related decline from organic hypogonadism due to known diseases of the testis, pituitary, and the hypothalamus. 10 Here, we determined the proportion of testosterone recipients within the VA who do have such a known diagnosis of the testis, pituitary, and hypothalamus. We then evaluated the characteristics of patients without a formal indication to receive testosterone who had nevertheless received it.…”

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confidence: 99%

Who Gets Testosterone? Patient Characteristics Associated with Testosterone Prescribing in the Veteran Affairs System: a Cross-Sectional Study

et al. 2016

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BACKGROUND: There has been concern about the growing off-label use of testosterone. Understanding the context within which testosterone is prescribed may contribute to interventions to improve prescribing. OBJECTIVE: To evaluate patient characteristics associated with receipt of testosterone. DESIGN: Cross-sectional. SETTING: A national cohort of male patients, who had received at least one outpatient prescription within the Veterans Affairs (VA) system during Fiscal Year 2008-Fiscal Year 2012. PARTICIPANTS: The study sample consisted of 682,915 non-HIV male patients, of whom 132,764 had received testosterone and a random 10% sample, 550,151, had not. MAIN MEASURES: Conditions and medications associated with testosterone prescription. KEY RESULTS: Only 6.3% of men who received testosterone from the VA during the study period had a disorder of the testis, pituitary or hypothalamus associated with male hypogonadism. Among patients without a diagnosed disorder of hypogonadism, the use of opioids and obesity were the strongest predictors of testosterone prescription. Patients receiving >100 mg/equivalents of oral morphine daily (adjusted odds ratio = 5.75, p < 0.001) and those with body mass index (BMI) >40 kg/m 2 (adjusted odds ratio = 3.01, p < 0.001) were more likely to receive testosterone than non-opioid users and men with BMI <25 kg/m 2 . Certain demographics (age 40-54, White race), comorbid conditions (sleep apnea, depression, and diabetes), and medications (antidepressants, systemic corticosteroids) also predicted a higher likelihood of testosterone receipt, all with an adjusted odds ratio less than 2 (p < 0.001). CONCLUSIONS: In the VA, 93.7% of men receiving testosterone did not have a diagnosed condition of the testes, pituitary, or hypothalamus. The strongest predictors of testosterone receipt (e.g., obesity, receipt of opioids), which though are associated with unapproved, off-label use, may be valid reasons for therapy. Interventions should aim to increase the proportion of testosterone recipients who have a valid indication.

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“…Prior to the FDA ruling, testosterone prescriptions for age-related and idiopathic hypogonadism were abundant. From 2001 to 2011, a three-fold increase in testosterone prescriptions in the United States was observed, which coincided with increases in testosterone prescriptions in 37 of 41 countries studied worldwide ( 2 , 9 ). In the U.S., the most common reasons for prescribing testosterone were hypogonadism (51%), fatigue (34%), erectile dysfunction (ED) (32%), and psychosexual dysfunction (12%) ( 9 ).…”

Section: Definitions and Treatment Of Hypogonadism—are We Treating A mentioning

confidence: 81%

“…Exogenous testosterone products have been FDA approved in the U.S. for over 50 years. However, there has been a dramatic increase in testosterone use in recent decades, and questions have arisen both about safety of these therapies as well as the direct-to-consumer marketing engaged in by pharmaceutical companies ( 2 , 3 ). The FDA recommendations and increased oversight are the culmination of multiple factors, with concerns about cardiovascular safety in men using the products serving as an obvious lightning rod for the FDA’s involvement ( 1 ).…”

Section: The 2014 Fda Hearing—how Did We Get There?mentioning

confidence: 99%

Testosterone therapy in the new era of Food and Drug Administration oversight

Desroches¹,

Kohn²,

Welliver³

et al. 2016

Transl. Androl. Urol.

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The Food and Drug Administration (FDA) introduced changes in labeling and indications for use to testosterone products in 2015 due to a possible increased risk of cardiovascular (CV) events. This decision was made based on six clinical studies—some that supported an increased CV risk, and some that did not. Since this decision, additional studies have been published examining the interplay between hypogonadism, CV risk, and testosterone, demonstrating that the risk may be lower than originally estimated. Clinicians are placed in a difficult position, as studies support an increased mortality risk in hypogonadal men, but also an increased risk of CV events in men on testosterone therapy. As a result, many clinicians will be more selective in their prescribing of testosterone. In this review, we examine how these new guidelines arose and how they may affect prescribing habits.

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Irrational Exuberance in Testosterone Prescribing

Cited by 19 publications

References 21 publications

Pharmacoepidemiology of testosterone: Curbing off‐label prescribing

Pharmacoepidemiology of testosterone: Curbing off‐label prescribing

Who Gets Testosterone? Patient Characteristics Associated with Testosterone Prescribing in the Veteran Affairs System: a Cross-Sectional Study

Testosterone therapy in the new era of Food and Drug Administration oversight

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