Direct-to-Consumer Online Platforms Expand Access, but Often Fail to Convey Risks of Testosterone Therapy

Demand for testosterone therapy has soared in the United States with more men seeking to increase hormone levels in hopes of enhancing virility, strength and energy. Testosterone therapy has become a burgeoning business with direct-to-consumer men’s health platforms proliferating online in recent years. While testosterone therapy benefits some men, it can be harmful for others, making it critical that patients understand the benefits and risks before starting the therapy.

A new Northwestern Medicine study published in JAMA Internal Medicine found that many of these platforms are not providing care in concordance with the American Urological Association (AUA) and Endocrine Society guidelines for the safe and effective management of men on testosterone therapy.

Using a secret shopper, the study authors evaluated seven US-based online companies that provide testosterone therapy in all 50 states. Utilizing a script to inquire about and initiate testosterone therapy, the secret shopper identified himself as a 34-year-old man with hypogonadal symptoms, including low energy and low libido, who was interested in future fertility. For each of the platforms, he completed the intake evaluation, required laboratory diagnostic testing and initial telemedicine consultation, which was conducted by either a nurse practitioner, physician assistant, or non-medically licensed individual.

The authors found that online platforms are offering therapies to men who do not meet guidelines for testosterone deficiency, while also failing to convey the risks and benefits of therapy. The study identifies guideline-discordant practices by direct-to-consumer testosterone therapy platforms, with the following findings:

• 85.7% of the platforms offered testosterone therapy despite the secret shopper having normal total testosterone (TT) and free testosterone levels and desiring future fertility.
• Only one of the seven platforms asked the secret shopper about recent cardiovascular events or his desire for future fertility.
• Criteria for offering testosterone therapy were discordant with AUA and ES guidelines with one platform only offering treatment for men with TT below 450 ng/dL (normal range = 264 – 916 ng/dL), while the other six have no threshold for treatment initiation.
• Half of the platforms quoted a treatment goal of more than 1,000 ng/dL TT levels and did not discuss fertility risks of testosterone therapy.
• 83.3% did not discuss the risks of polycythemia.
• In addition to testosterone therapy, the secret shopper was also offered a broad range of off-label medications.

As the popularity of direct-to-consumer testosterone therapy grows, the authors hope that future policy initiatives will facilitate more consistent and guideline-based care by these entities.