Surfing the MASH Tsunami

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This final segment with Jeff McIntyre of the Global Liver Institute (GLI) explores the panelists’ final thoughts around optimisms and worries for the Fatty Liver field going forward. Next week, the Surfersinvite you to join a live session covering the ICER draft pricing recommendations on resmetirom and obeticholic acid (OCA).

This exclusive opportunity for the Surfing NASH community to attend the live recording as audience members will take place on Monday, March 13th at 1700h CET, 1600h. In doing so, you will be able to voice questions and feedback on the pressing topic of imminent NASH drug approvals. To reserve a spot, please visit the following link: https://bit.ly/Surf-Live-With-Us.

To learn more about this opportunity, follow us on LinkedIn and subscribe to the newsletter. Alternatively, you can write to us directly at [email protected].

We look forward to surfing together soon!

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The Surfers are joined by Jeff McIntyre of the Global Liver Institute (GLI) for a thought-provoking impromptu session on what’s happening thus far for the Fatty Liver field in 2023. In this conversation, Jeff continues on collaborative work by GLI to more formally “medicalize” obesity as a term considerate of genetic backgrounds and metabolic dynaminisms. He relates this grappling around nomenclature to that experienced in the Fatty Liver forum. Comments shift toward the subject of nutrition and an ominous landscape of public health policy. Jeff calls for hepatology associations to join efforts in assessing package nutrition labeling, advocating for reductions of high fructose corn syrup and other measures of rectifying harmful food marketing to children.  He notes there to be a conversation around rule-making happening at the FDA right now on what defines a “healthy” food. Jeff asserts that, “frankly, chronic disease is really underrepresented in that conversation.” Worse yet, representatives of those companies pushing the agenda of junk food are ascertained to be present and lobbying for their products one way or another. At this point, the other panelists voice impressions to these concerns.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected].

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The Surfers are joined by Jeff McIntyre of the Global Liver Institute for a thought-provoking impromptu session on what’s happening thus far for the Fatty Liver field in 2023. This session features Jeff’s insights around the imminent drug approvals of obeticholic acid and resmetirom. His analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft’s reference to NASH as a non-progressive disease - a position which the panelists readily refute. Jeff’s positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.

The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines’ referral to FIB-4 as such a test. This summons quote of Quentin Anstee's repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it's two generations of successive approximation of what we've had before.

As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast’s recent conversation with Tim Jobson, founder of Predictive Health Intelligence, which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected].

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The Surfers host a thought-provoking impromptu session on what’s happening thus far for the Fatty Liver field in 2023. Jörn Schattenberg leads this conversation with comments around diagnostic and therapeutic advancements following the momentum gathered at NASH-TAG in January. He points to the large number of abstracts (estimated at over 2500!) submitted to the upcoming EASL Congress held in Vienna this June. While drugs are leading the way, Jörn insists diagnostics are closely following and contributing to "excitement on both borders.” Roger Green notes activity around organizing trials that incorporate non-invasive endpoints.

Louise Campbell adds her highlight to be the recent AASLD guidance and its focus on clarifying CAP scores for improved FibroScan assessment. This is joint with eager anticipation of a NICE approval for access to FibroScan in the primary care setting. Roger comments on emerging competitor technologies, such as E-Scopics, and their influence on industry uptake of NITs. Combined with the various emerging guidelines and guidances, more doctors and specialties should begin focusing on how and when to test. Louise notes the potential challenges behind adopting liver-conscious practices for endocrinology and cardiology clinics in that there will be questions around how exactly this initiative is administered. However, these are exciting and surmountable challenges with rewarding implications. In Louise’s experience, “if you find real time with that person in the room, you can really make a change.” Roger connects these ideas around frontline screening to the podcast’s latest ventures in launching the Rising Tide series available at SurfingNASH.com. Lastly, he describes emerging energies around payer dynamics and drug utilization in the US.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On! 

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The Surfers are joined by Jeff McIntyre of the Global Liver Institute for a thought-provoking impromptu session on what’s happening thus far for the Fatty Liver field in 2023. The panelists touch on topics which elicit responses ranging from positive excitement around scientific developments to head-scratching concern over public policy positions.

06:31
Jörn Schattenberg opens with comments on diagnostic and therapeutic advancements which follow the momentum gathered at an energizing NASH-TAG conference in January. He specifically points to the numerous abstracts (estimated at over 2500!) submitted that will contribute to a scientifically-stimulating EASL Congress held in Vienna this June. Jörn emphasizes that while drugs are leading the way, diagnostics are closely following and contributing to "excitement on both borders.” Louise Campbell adds her thoughts around the recent AASLD guidance and its focus on clarifying CAP scores for improved FibroScan assessment. Roger Green notes emerging competitor technologies, such as E-Scopics, and their influence on industry uptake of NITs.

19:17
Jeff expands on the trajectory of imminent drug approvals of obeticholic acid and resmetirom. He goes on to express mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft’s reference to NASH as a non-progressive disease - a position that the panelists clearly debunk. He next speculates on the future standard for noninvasive testing and biomarkers. His comments emphasize the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines’ referral to FIB-4 as such a test.

29:31
Jeff introduces collaborative work by GLI which sets out to more formally “medicalize” obesity as a term considerate of genetic backgrounds and metabolic dynaminisms. He relates this discussion around nomenclature to that experienced in the Fatty Liver space. Conversation segues to the subject of nutrition and the often ominous landscape of public health policy.

37:14
Roger introduces a timely Lancet paper which coincided with Surfing NASH’s focus on pediatric and adolescent NAFLD and NASH. The US-based study suggests that in five randomly allocated centers from 2002 to 2018, annual increase in incidence of Type-2 diabetes among 10-19 year-olds was a staggering 5% per year. He connects the findings to the aforementioned ideas around public health policy and nutrition. As the session winds down, Roger invites the panelists to provide the most significant and optimistic thing they will be touching over the next three months followed by the greatest fear each has in the same space. Listen to the full feature to hear their responses and the rest of this well-balanced conversation.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected]. 

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This episode From the Vault comes from the 2022 Liver Conference, where over 400 liver disease stakeholders gathered in Scottsdale, Arizona for the event sponsored by the Chronic Liver Disease Foundation (CLDF). The main meeting ran on a Friday and Saturday and was preceded on Thursday by a half-day session devoted exclusively to NASH (NASH Connect). Episode 15.3 of Season 3 and its conversations capture some of the thinking that went into the program design and some highlights of the NASH-related sessions.

This conversation focuses on the issue of pediatric NASH and NAFLD. Naim Alkhouri discusses the urgent need to include pediatric and adolescent patients in clinical trials, while Louise Campbell asked whether we could possibly get results soon enough to help today’s youngsters with NAFLD or NASH. Marcelo Kugelmas stated his firm conviction that we need to prove safety and efficacy available, but that there are many other steps we can take (lifestyle modification, for one) if we have adequate commitment. This led Roger Green to note government action in the UK to improve the informational quality of food and fast-food restaurant advertising and to ask whether something similar could happen in the U.S. This sparked discussion about food labelling in the UK, Michele Obama’s program in the US, the impact of sugar taxes and food advertising bans during certain times of day, and the overall potential for government activities to succeed. In the end, the group agreed that with money, an advertising campaign to back these kinds of issues might have an excellent result.

This episode and conversations are sponsored by Madrigal Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company pursuing novel therapeutics for NASH. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver. Resmetirom is currently being evaluated in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1, designed to demonstrate multiple benefits in patients with NASH. For more information, visit www.madrigalpharma.com.

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In yet another topical debut, Surfing NASH explores pediatric and adolescent Fatty Liver disease, its alarming incidence rate and developing the field's understanding around how to treat a vulnerable subpopulation. The Surfers are joined in discussion by Naim Alkhouri and chief of Gastroenterology, Hepatology and Nutrition at Children’s Hospital Los Angeles, Rohit Kohli, for a special session which illuminates a public health crisis intimate to the two extremely knowledgeable guests.

Roger Green leads this final conversation with an apt metaphor. He suggests that a population facing increasing severity downstream is like dealing with a momentous snowball rolling downhill and amassing trouble. With this in mind, he asks the panelists where they think we have the ability in advance of drug trials for pediatrics to intervene and either slow or ideally eviscerate the snowball. Rohit responds that it depends on the slope of the hill, and every child, because of underlying genetics and environmental influences, has a different slope. Both Jörn Schattenberg and Naim describe this as an arena of prevention. Finally, Louise Campbell raises grave concern over coping with the enormous industry influence on the milieu of nutrition surrounding children.

If you have questions or interest around pediatric and adolescent Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write us directly at [email protected].

Stay Safe and Surf On! 

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In yet another topical debut, Surfing NASH explores pediatric and adolescent Fatty Liver disease, its alarming incidence rate and developing the field's understanding around how to treat a vulnerable subpopulation. The Surfers are joined in discussion by Naim Alkhouri and chief of Gastroenterology, Hepatology and Nutrition at Children’s Hospital Los Angeles, Rohit Kohli, for a special session which illuminates a public health crisis intimate to the two extremely knowledgeable guests.

This conversation begins with Louise Campbell’s note that, on average, it takes 17 years for clinical trials to be implemented in real world settings. She asks whether it’s an option to collect noninvasive clinical data and determine whether this alone instigates behavioral change despite it not proving clinical diagnosis. This sparks the panelists to explore ideas around how to effectively introduce lifestyle interventions for children and families at a societal scale. It's noted with unanimous agreement that nutritional matters are family matters. Roger Green adds comments on the influence of school education in trickling information on liver health to homes. Louise asserts that from a cost analysis perspective, screening children with assessments which include liver health can actually suppress or prevent cardiovascular events in the future. This prompts Rohit to describe guidelines that utilize annual physicals with adolescents as an opportunity to track liver health.

At the end of the session, Naim highlights several more recent studies that are developing the field’s understanding of early life risk factors and the natural history of this disease. His final comments consider the implications of prescribing therapies to adolescents progressing in instances where lifestyle interventions fail to halt disease progression.

If you have questions or interest around pediatric and adolescent Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write us directly at [email protected].

Stay Safe and Surf On!

Send us Fan Mail

In yet another topical debut, Surfing NASH explores pediatric and adolescent Fatty Liver disease, its alarming prevalence and developing the field's understanding around how to treat this vulnerable subpopulation. The Surfers are joined in discussion by Naim Alkhouri and chief of Gastroenterology, Hepatology and Nutrition at Children’s Hospital Los Angeles, Rohit Kohli for a special session which illuminates a critical issue intimate to the two extremely knowledgeable guests.

Jörn Schattenberg steers this conversation toward the cardiometabolic complications behind patients living longer with Fatty Livers. Naim describes a paper which sought to strengthen understanding of epidemiology by histopathology reports in Sweden. With access to virtually all liver biopsies in the country, the group set out to identify cardiovascular disease emerging in patients previously diagnosed with NASH under the age of 25. The conclusion: compared with matched population controls, patients with biopsy-proven NAFLD had significantly higher incidence of major adverse cardiovascular events. Excess risk was evident across all stages of NAFLD and increased with worsening disease severity. 

At this point, Rohit comments on the role and appropriateness of bariatric surgery in adolescents to mitigate the long-term metabolic consequences of obesity. Louise Campbell asks for clarification around histopathological differences between adolescents and adults. Rohit and Naim then describe zonal analysis which characterizes an alternate pattern of progressive NAFLD in children whereby the inflammatory foci is more portal-centric. It’s noted that a shift typically occurs around the age of 12 and 13 when hepatocyte ballooning becomes a predominant feature rather than portal inflammation. Naim asserts this has great implications for designing histology-based pediatric trials because the resolution of hepatocellular ballooning is considered a hallmark of NASH resolution.

The remainder of the session considers unique challenges associated with establishing NITs as endpoints for trials with adolescents. In this context, Rohit and Naim describe a spate of noninvasive technologies and tools with varying inaccuracies. FIB-4 is noted to be particularly inadequate in assessing the pediatric population. Finally, Naim comments on the need for regulatory guidance as significant fibrosis at an early age may require use of medications. He suggests that it’s critical to avoid conducting the same repeat biopsies as designed in Phase 3 clinical clinical trials for adults.

If you have questions or interest around pediatric and adolescent Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write us directly at [email protected]. 

Stay Safe and Surf On!