loader from loading.io

Should Testosterone Replacement Therapy Be Less Regulated?

MedCity Pivot

Release Date: 02/22/2026

The Evolution of At-Home Care show art The Evolution of At-Home Care

MedCity Pivot

SUMMARY Arundhati Parmar speaks with Jill Schwartz-Chevlin, Chief Medical Officer at Vinca, about the evolution of palliative care from a hospital-based, end-of-life service to a community and home-based model for patients living with serious illness. Jill explains how Vinca grew from an advanced care planning platform into a value-based palliative care company serving patients across five states, primarily through Medicaid and Medicare Advantage plans. The conversation covers the critical distinction between palliative care and hospice, the cost savings data that health plans are paying...

info_outline
Interoperability with CEO of Particle Health show art Interoperability with CEO of Particle Health

MedCity Pivot

Episode Summary Particle Health CEO Jason Prestinario joins MedCity Pivot to assess the state of U.S. healthcare interoperability with clear-eyed candor. He grades the technical infrastructure a B — data can move — but gives access governance a C, because the rules around who uses data, and how, remain murky and poorly enforced. Jason draws a direct line between true interoperability and the viability of value-based care: without frictionless data access, accountability for patient outcomes is impossible. The conversation also covers Particle's antitrust lawsuit against Epic, now past its...

info_outline
Modernizing Prior Authorization to Boost Transparency show art Modernizing Prior Authorization to Boost Transparency

MedCity Pivot

Episode Summary In this episode of the MedCity Pivot Podcast, host Arundhati Parmar sits down with Javier Gonzalez (Abarca Health) and Tanvi Patel (Amazon Pharmacy) to unpack one of healthcare’s most frustrating processes: prior authorization. The conversation explores how outdated systems, lack of transparency, and fragmented communication are eroding patient trust and delaying care. From policy complexity and data gaps to operational risks, the guests break down why prior authorization remains such a challenge—and what it will take to modernize it at scale. They also highlight the...

info_outline
Tackling Existential Crisis show art Tackling Existential Crisis

MedCity Pivot

Summary In this episode of the Med City Pivot Podcast, host Arundhati Parmar speaks with Lars Petersen about one of the most remarkable corporate transformations in modern business history. Facing a catastrophic collapse of its core film business in the mid-2000s due to the rise of digital photography, Fujifilm executed a bold and strategic pivot into healthcare and life sciences. The company diversified aggressively, leveraging its deep expertise in materials science, imaging, and innovation to build a thriving biotechnology and medical technology ecosystem. Today, Fujifilm operates as a...

info_outline
Should Testosterone Replacement Therapy Be Less Regulated? show art Should Testosterone Replacement Therapy Be Less Regulated?

MedCity Pivot

EPISODE SUMMARY 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...

info_outline
Separating Hype from Reality in AI show art Separating Hype from Reality in AI

MedCity Pivot

Summary  Tune into MedCity Pivot Podcast with host Arundhati Parmar as three healthcare tech leaders—Serge Perras, Ton Roelandse, and Bertil Chappuis—decode AI's true potential in healthcare. Explore its role in enhancing efficiency and busting myths about AI supremacy.   Episode Highlights 00:00:19 - The high bar for AI safety in healthcare. 00:01:29 - AI's current hype and exaggerated promises. 00:03:57 - Misconceptions about AI replacing healthcare roles. 00:05:51 - Meaningful AI use cases: Prior authorization automation. 00:06:52 - AI in triage and its capacity enhancements....

info_outline
How Emergency Departments Are Using Real-Time Data to Improve Outcomes with Dr. Hamad Husainy and Dr. Barbara Bond show art How Emergency Departments Are Using Real-Time Data to Improve Outcomes with Dr. Hamad Husainy and Dr. Barbara Bond

MedCity Pivot

During the episode, MedCity News Associate Editor Katie Adams interviews Dr. Hamad Husainy, chief medical officer at PointClickCare, and Dr. Barbara Bond, a physician at Sutter Health, about how AI can help improve patient outcomes in the emergency department.   Episode Resources Connect with Arundhati Parmar     Review, Subscribe and Share If you like what you hear please leave a review by   Make sure you’re subscribed to the podcast so you get the latest episodes.    

info_outline
A Flexible Approach to Pharmacy Benefits Management with Adriana Ramirez and Matt Gibbs show art A Flexible Approach to Pharmacy Benefits Management with Adriana Ramirez and Matt Gibbs

MedCity Pivot

I interviewed Adriana Ramirez and Matt Gibbs, and we spoke about how a new approach to pharmacy benefits management.   Episode Resources Connect with Arundhati Parmar   Connect with Adriana Ramirez and Matt Gibbs       Review, Subscribe and Share If you like what you hear please leave a review by   Make sure you’re subscribed to the podcast so you get the latest episodes.  

info_outline
Brain Health at the Point of Care with Dr. Iftach Dolev show art Brain Health at the Point of Care with Dr. Iftach Dolev

MedCity Pivot

I am interviewing Dr. Iftach Dolev, co-founder and CEO of QuantalX a neurodiagnostics company that has just received FDA clearance for its device.   Episode Resources Connect with Arundhati Parmar   Connect with Dr. Iftach Dolev     Review, Subscribe and Share If you like what you hear please leave a review by   Make sure you’re subscribed to the podcast so you get the latest episodes.  

info_outline
How AI Is Reshaping Care Navigation and Patient Outcomes with Shannon Skaggs show art How AI Is Reshaping Care Navigation and Patient Outcomes with Shannon Skaggs

MedCity Pivot

This episode was sponsored by Quantum Health. Katie Adams, associate editor at MedCity News, interviewed Shannon Skaggs, chief AI officer at Quantum Health, about how AI is reshaping the care navigation and benefits guidance world.   Episode Resources Connect with Arundhati Parmar   Connect with Shannon Skaggs       Review, Subscribe and Share If you like what you hear please leave a review by   Make sure you’re subscribed to the podcast so you get the latest episodes.  

info_outline
 
More Episodes

EPISODE SUMMARY

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.

Episode Resources

KEYWORDS

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?