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:
The scientific evidence surrounding cardiovascular and prostate safety
The differences between injectable and oral testosterone therapies
The stigma and logistical barriers created by controlled substance status
How GLP-1 drugs intersect with hormone health and muscle preservation
The possibility of expanding testosterone therapy access to women
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At its core, this episode examines whether testosterone is being regulated based on outdated controversy rather than modern clinical science — and what that means for patients navigating care today.
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
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?
