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As the NASH pandemic grows in the number and diversity of patient cases, one patient group receiving increased notice includes patients with "lean NASH," those whose BMI levels are "normal." Last month, Gastroenterology published Best Practice recommendations for diagnosing and treating lean NASH. Two of the authors, Drs. Michelle Long and Mazen Noureddin, were good enough to come on the podcast to share the thinking behind this article along with its key observations and recommendations.

This conversation starts with Roger Green asking Michelle and Mazen how they came to write this piece and how the paper came together working with co-author, Dr. Joseph Lim. First, as Michelle notes, "we had to all get on the same page," on the issue of the highest BMI that would be considered lean or, more precisely, not overweight. From there, the team outlined 15 Best Practices based on clinical experience, and set out to refine these based on relevant literature and recommendations from colleagues and reviewers. The co-authors note that while little of what they learned while preparing this paper was surprising, it forced them to focus on creating a fairly simple set of stepwise goals for clinicians to follow.  Louise Campbell joins the conversation to praise the simplicity and clarity of the Best Practices chart the co-authors created. 

After noting that this algorithm is not very different from others,  Mazen goes on to mention "a couple of things...that we’re proud of:" identification of high-risk patients based on age (over 40) or presence of Type 2 diabetes. He also notes that they provided greater clarity around more advanced non-invasive tests like ELF, MAST, FAST, MEFIB, MRI, and cT1.

The conversation shifts to focus on the recommendation to retest every 6 or 12 months. Louise notes this approvingly. The group agrees that screening T2D patients annually using FIB-4 is not very different than screening annually for eye, kidney or neurological complications. Roger Green joins the conversation to suggest a 3-5 year follow-up recommendation is not patient-centric, but might calm payers concerned about skyrocketing costs of treating Fatty Liver disease. Mazen shares his expectation that yearly evaluation will be cost-effective and patient-centric. Roger shares an informal belief he has developed that whether due to later stage diagnoses or different disease pathogenesis, lean NASH patients might be more costly because patients progress to cirrhosis more quickly after the original diagnosis. Michelle tends to agree but notes that more research is needed on this.

Next, the conversation shifts toward diagnostic approaches. Roger mentions the possible benefit of the "Fibrosis First" method that Ian Rowe discussed the previous week (S3, E39), particularly appropriate when primary care providers observe danger signs in lean patients. Mazen points to extremely elevated liver enzyme levels (ALT of 80 or 90). Michelle agrees, but notes that most of her lean NASH patients are diagnosed in an ED with complications of cirrhosis. The group then spends time asking what might make primary care providers comfortable testing for fibrosis, even if only to pass the patient on to the appropriate specialist.  

Roger asks what different groups can learn from this paper. Michelle states that this is a clear call for more research. Mazen points to Table 2 in the paper, which lists other diseases that hepatologists should consider when evaluating these patients. He continues to state that the document is helpful for non-hepatologists and hepatologists alike. Finally, he points out that clinical trials are pivotal for these patients. 

The last several moments focus on how to ask patients about alcohol consumption and then the closing question. Michelle notes the importance of using lists and tables in the paper to guide the special issues in treating these patients.

S3-E40 - Best Practices in Lean NASH -- Authors Provide Back Story

Navigating NAFLD/NASH clinical trials through the pandemic

Dr. Stephen Harrison discusses several ways the pandemic is affecting the planning and execution of clinical trials and our panelists discuss implications for investors, C-suite executives, and forecasters in our first episode, COVID CHAOS: Navigating NAFLD/NASH clinical trials through the pandemic. 

(FULL TRANSCRIPT: https://bit.ly/COVID-Chaos)

Drug developers, investors, researchers, and corporate executives, wrestle weekly to understand what is happening in commercial development of NASH medications. Join hepatology researcher and key opinion leader, Stephen Harrison, star equity analyst, Yasmeen Rahimi, C-suite veteran, Peter Traber, and forecasting and pricing guru, Roger Green, as they discuss the issues affecting the evolving NASH market from their own unique perspectives on this week’s edition of Surfing the NASH Tsunami.

Roger Green (00:31): Hi. This is Roger Green, and welcome to the initial podcast of Surfing the NASH Tsunami, a podcast for people who are involved with drug development and commercialization in the liver disease space. We’ve developed this podcast because over the last month we’ve heard tons of questions from virtually everybody involved in this community about the impact of COVID, first, and then how that’s going to affect the entire domino chain of upcoming market events, product readouts, clinical trials, launches, all that going forward.

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

COVID CHAOS - Ep 1

What investors want to know about NASH development during the pandemic.

Yasmeen Rahimi poses five questions NASH investors ask her about the impact of COVID-19 on NASH clinical and commercial development and our panelists provide answers in our second episode, FIVE $IMPLE PIECES: What investors want to know about NASH development during the pandemic.
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Epsiode Transcription: https://bit.ly/WhatInvestorsWantToKnow

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Five $imple Pieces - Ep 2

Critical considerations for companies developing NASH drugs

Peter Traber focuses on ways COVID-19 can affect drug development and broader corporate strategies while our panelists weigh in on implications for clinical researchers, investors and forecasters in our third episode: C-SUITE COVID-19 CHALLENGES.

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Full Transcription: https://bit.ly/CSuiteCOVID19Challenges

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

C-Suite COVID-19 Challenges - Ep 3

Three possible scenarios for development of the NASH market.

Roger Green presents three possible directions for the NASH market over the next 5-10 years and asks our panelists, including our guest, renowned nurse and patient advocate Louise Campbell, to suggest critical market-driving factors.

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Full Transcription: https://bit.ly/Ep4-Surfing-NASH

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

When You Get To A Fork In The Road - Ep 4

Clinical trial results that are changing how we look at NASH

Stephen Harrison leads a review of two recent Phase 3 data statements: the outcome of GenFit’s RESOLVE-IT trial and Madrigal Pharmaceuticals’ recent press release on the extension of its MAESTRO Phase 3 NASH trial. Listen to a thoughtful, far-reaching sometimes funny conversation as the group explores WILD TIMES IN NASH-VILLE – PART I.

Full Transcript: https://bit.ly/Ep5-NASH-VILLE-Pt1

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Wild Times In NASH-Ville – Part I - Ep 5

Exploring the controversy over the name(s) to use when describing Fatty Liver disease(s)

Professor Quentin Anstee joins the Surfers for thoughtful consideration of the factors that should drive the decision on what name(s) to use for different Fatty Liver diseases. The group considers a range of issues from our level of scientific knowledge to the semiotics of naming to how patients react to certain disease descriptions, all in a stimulating, freewheeling discussion.

Full Episode Transcripts: https://bit.ly/Ep6-WhatsInAName

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

What’s in a Name: NAFLD or MAFLD? - Ep 6

Reviewing press releases reporting preliminary findings from six recently announced Phase 2 trials

Stephen Harrison leads the Surfers, with guest Louise Campbell, through an examination of six Phase 2 clinical trials that put forth press releases during the last three months. In all, the discussion created an air of optimism based on better clinical outcomes than we have seen with earlier NASH drugs, all from medicines with distinct but potentially complementary modes of action.

Full Episode Transcripts: https://bit.ly/Ep7-NASH-VILLE-Pt2

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

NASH-Ville - Part 2: Better Days Ahead? - Ep 7

Room for improvement

GenFit Head of Global Diagnostics Suneil Hosmane joins the Surfers in exploring the current strengths and drawbacks of Fatty Liver diagnostics. The conversation considers the needs of drug developers, clinicians and patients, and highlights opportunities for improving diagnostic options.

Full Episode Transcripts: https://bit.ly/Ep8-Diagnostics-Pt1

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Diagnosing Diagnostics – Part I - Ep 8

Surfing the NASH Tsunami celebrates a growing and increasingly important global event for the Fatty Liver community.

Global Liver Institute President & CEO Donna Cryer joins the Surfers to discuss the focus, passion, and advocacy that have shaped and grown International NASH Day. Learn how IND started and what it represents today. As you listen, envision the role you can play in the future of Fatty Liver advocacy and education.

Full Episode Transcript: https://bit.ly/Ep9-International-NASHDay

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

International NASH Day is Here! - Ep 9

What would create greater value for patients and providers?

Professor Mary Rinella of Northwestern University and Suneil Hosmane of GenFit join Stephen, Louise, and Roger to explore which of these strategies can do the most to improve patient diagnosis and management. The answer might surprise you.

Full Episode Transcripts: https://bit.ly/Ep10-Diagnosing-Diagnostics-Pt2

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Diagnosing Diagnostics II: Tools vs. Teaching - Ep 10

Drug developers, investors, researchers, and corporate executives wrestle weekly to understand what is happening in commercial development of NASH medications. Hepatology researcher and Key Opinion Leader Stephen Harrison, M.D., C-suite veteran Peter Traber, M.D., and Forecasting and pricing guru Roger Green, M.B.A. discuss the issues affecting the evolving NASH market from their own unique perspectives on the Surfing the NASH Tsunami podcast.

S3-E40 - Best Practices in Lean NASH -- Authors Provide Back Story

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