madman
Super Moderator
Hitting the nail on the head here!
* 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.
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.
Chapters:
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?
* 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.
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.
Chapters:
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?
