What Happened to Testosterone?

“Is it low T?” A surge of print and media advertising has contributed to the widespread use of testosterone for conditions that have not been approved by the FDA.

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“Low energy?” “Low sex drive?” “Is it low T?” A surge of these print and media advertisements around 2009 informed the male audience that they might be suffering from low testosterone (low T) levels or “manopause” (a term coined by TIME magazine in their July 2014 issue). The suggestion: “ask your doctor.” This direct-to-consumer advertising coincided with several other developments that enabled widespread use of testosterone. These included the establishment of specialty “low T” clinics, availability of new patient-friendly testosterone modalities (gels, patches, etc.), sale of cheaper prescriptions through internet pharmacies in Canada, and vague clinical practice guidelines about whether age-related decline in testosterone should be treated at all.

It is well-known that the testosterone level decreases with age. The important question is whether this causes symptoms, such as low energy, and how much testosterone replacement helps patients. Guidelines have been vague on this question, allowing direct-to-consumer advertising to become the dominant voice.

The U.S. Food and Drug Administration (FDA), which is usually conservative in its interpretation of the evidence, has only approved the use of testosterone for diagnosed conditions of the hypothalamus, pituitary, and testicles in which the male body does not produce normal levels. However, the great majority of patients receiving testosterone (as many as 95%) do not have such a condition.

This heightened focus on testosterone helped propel my research career trajectory, leading to a Career Development Award focusing on understanding testosterone prescribing in the Veteran Health Administration (VHA). My colleagues and I have shown that, in the VHA, testosterone is frequently prescribed inappropriately for a number of reasons including insufficient laboratory workups before and after starting therapy, and prescribing testosterone for conditions not been approved by the FDA. We also found that testosterone prescriptions have been decreasing in the VHA since 2014, possibly because of increased FDA messaging about the possible risks associated with this therapy.

This pattern of unbridled enthusiasm for a new and heavily-advertised medication, followed by warnings regarding safety risks, is familiar. Widespread use of hormone replacement therapy by menopausal women prior to 2002 is another example of the effect aggressive marketing efforts on the part of drug companies can have on prescribing practices. After evidence emerged from the Women’s Health Initiative that hormone replacement increased the risk of breast cancer and cardiovascular disease, prescriptions fell sharply. This pendulum swing is similar to the testosterone story and offers important lessons.

As with the Women’s Health Initiative Study, researchers agree that a large-scale long-term testosterone randomized study is needed to confirm the potential risks and benefits of this therapy. While the search for definitive answers about the health effects of testosterone therapy continues, my ongoing research seeks to understand what is driving testosterone prescriptions and the nuances of patient demand among men who have a clinically valid diagnosis and those who seek it out for life-style enhancing purposes. A greater understanding of these reasons for testosterone use will better inform a clinicians’ decision-making process for prescribing and facilitate appropriate use of this therapy in patients who need it the most.

The author wishes to acknowledge Dr. Adam J. Rose, Associate Professor, Boston University School of Medicine, for taking the time to review this piece.

Feature image: Graham Richardson, BICEPS3, used under CC BY 2.0