MedCity Pivot Should Testosterone Replacement Therapy Be Less Regulated?
In this episode, Arundhati Parmar interviews Shalin Shah, CEO of Marius Pharmaceuticals, about Testosterone Replacement Therapy (TRT) and the long-standing regulatory classification that places testosterone as a Schedule III controlled substance.
Shah explains that testosterone was scheduled in 1990 following Olympic doping scandals — despite opposition at the time from the FDA, DEA, and the American Medical Association. More than 30 years later, he argues that the regulatory framework no longer reflects current clinical evidence and may be doing more harm than good.
The conversation explores:
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The scientific evidence surrounding cardiovascular and prostate safety
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The differences between injectable and oral testosterone therapies
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The stigma and logistical barriers created by controlled substance status
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How GLP-1 drugs intersect with hormone health and muscle preservation
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The possibility of expanding testosterone therapy access to women
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Whether the current regulatory environment may revisit testosterone scheduling
At its core, this episode examines whether testosterone is being regulated based on outdated controversy rather than modern clinical science — and what that means for patients navigating care today.
Episode Resources-
Connect with Arundhati Parmar
Testosterone Replacement Therapy TRT regulation Schedule III classification Controlled substances Hormone therapy stigma Men's health Women's hormone therapy TRAVERSE study Cardiovascular risk Prostate cancer risk Oral testosterone Injectable testosterone Hematocrit levels GLP-1 muscle loss Hypogonadism FDA regulation Healthcare policy Hormone optimization
EPISODE HIGHLIGHTS
00:00–01:40 - Why testosterone became a Schedule III controlled substance in 1990 01:40–02:30 - Political backlash after Olympic doping scandals 02:30–03:56 - Testosterone as the only controlled hormone 03:56–04:58 - The physiologic role of testosterone across multiple organ systems 04:58–06:19 - Cardiovascular and prostate cancer risk: What the TRAVERSE study showed 06:19–07:04 - Physiologic vs. supraphysiologic dosing 07:04–08:49 - How controlled status creates stigma and access barriers 08:49–10:10 - Provider tracking, pharmacy hurdles, and patient friction 10:10–11:48 - Would deregulation increase abuse or doping? 11:48–13:20 - GLP-1 drugs, rapid weight loss, and muscle preservation 13:20–15:08 - Testosterone in women: The overlooked half of the population 15:08–16:22 - Injectable vs oral TRT: Mimicking natural diurnal rhythms 16:22–17:40 - Hematocrit elevation differences between injections and oral therapy 17:40–19:07 - Side effect profiles and hormone signaling differences 19:07–20:32 - Go-to-market strategy: Cash pay vs insurance coverage 20:32–21:24 - Stigma among payers and barriers to reimbursement 21:24–22:43 - Expanding label indications and idiopathic hypogonadism 22:43–22:22 - Could the current administration reconsider testosterone scheduling?