How Regulated Is Online Testosterone Prescribing?

Online testosterone prescribing has become a topic of concern for federal officials as they consider the future of telemedicine. The issue revolves around whether online direct-to-consumer clinics should be able to continue to prescribe testosterone therapy without in-person consultations, a practice that gained traction during the COVID-19 pandemic. This practice has allowed individuals to bypass “low T” clinics physically but has raised concerns about overprescribing and improper practices.

Low testosterone in cisgender men, also known as testosterone deficiency, can cause distressing symptoms such as fatigue, low sex drive, and erectile dysfunction (ED). Nevertheless, these symptoms can occur for reasons other than low testosterone, and taking testosterone when one’s levels are already in the normal range can have damaging side effects.

Evidence suggests that some online clinics have prescribed testosterone inappropriately to men who do not need it. In fact, a recent study revealed that out of seven online-only clinics, six prescribed testosterone to an undercover urologist who had normal testosterone levels and did not meet the treatment criteria set by the American Urological Association (AUA) and the Endocrine Society. (The AUA Guideline for the Evaluation and Management of Testosterone Deficiency suggests using a total testosterone level below 300 ng/dL as a reasonable cutoff for a diagnosis of low testosterone).

As such, there is concern that online clinics are overprescribing testosterone to men seeking relief from issues like fatigue and decreased libido without properly counseling them on the potential side effects. This is worrisome because testosterone therapy could possibly increase a person’s risk of cardiac problems (this has been debated), can suppress a man’s sperm production leading to fertility problems, and can cause shrunken testicles, hot flashes, depression, and breast growth. It may also contribute to the development of sleep apnea, benign prostatic hyperplasia (BPH), and thickening of the blood. Lastly, an unknown effect of raising testosterone levels beyond the normal range may be an increased risk of prostate cancer, but more research is needed to determine if this is the case.

Testosterone therapy gained popularity in the 2000s when it was promoted as a way for men to boost their virility and vitality. This led to the growth of clinics offering testosterone treatments, both online and in-person. Before the pandemic, however, testosterone prescriptions required in-person medical visits, but this requirement was relaxed during the pandemic in an effort to minimize in-person contacts.

Moving forward, the future of this testosterone prescribing practice is uncertain. The United States Drug Enforcement Administration (DEA) is currently reevaluating the flexibility granted to telemedicine providers during the COVID-19 pandemic, but at this time, nothing has been decided. The DEA’s plans to revert to pre-pandemic testosterone prescription regulations have met with resistance from several groups, including members of the transgender community who worry about the potential loss of access to gender-affirming testosterone treatments.

Dr. Justin Dubin, urologist and author of the aforementioned study, explained, “While telemedicine has many benefits including access to care and helping men with health issues that can often have a big stigma around them, we need to be aware of the potential pitfalls so we can continue to improve the services being provided. By identifying problems now, we can help ensure that patients get appropriate and safe care.”

When asked if he could provide one takeaway message for patients regarding online testosterone prescription, Dr. Dubin responded, “Testosterone therapy has many benefits, but it also has risks and is not appropriate for everyone, especially men who are interested in future fertility. Before considering using it, it is important to talk with your local healthcare provider.”

For more information on this topic, please read these publications from the ISSM Journals: The Journal of Sexual Medicine, Sexual Medicine Reviews, and Sexual Medicine Open Access:

Testosterone Therapy: Do American and European Clinicians Have Different Approaches?

Controversies in Testosterone Therapy

Use, Misuse and Abuse of Testosterone and Other Androgens

References:

Dotinga, R. (2023, July 28). The Wild West of Online Testosterone Prescribing. MedPage Today. https://www.medpagetoday.com/special-reports/exclusives/105675

Dubin, J. M., Jesse, E., Fantus, R. J., Bennett, N. E., Brannigan, R. E., Thirumavalavan, N., & Halpern, J. A. (2022). Guideline-discordant care among direct-to-consumer testosterone therapy platforms. JAMA internal medicine, 182(12), 1321-1323. doi: 10.1001/jamainternmed.2022.4928

Mulhall, J.P., Trost, L.W., Brannigan, R.E., Kurtz, E.G., Redmon, J.B., Chiles, K.A., Lightner, D.J., Miner, M.M., Murad, M.H., Nelson, C.J., & Platz, E.A. (2018). Evaluation and management of testosterone deficiency: AUA guideline. The Journal of urology, 200(2), 423-432.