Surfing the NASH Tsunami

The process of creating a new MASLD nomenclature for the condition formerly known as Fatty Liver Disease was a multi-year process with unique challenges and complications. Three leaders in the process, Maru Rinella, Jeff Lazarus and Meena Bansal, and patient advocate Mike Betel join Louise Campbell and Roger Green to discuss the process, transition and rollout.

00:00:00 - Surf's Up: Season 5 Episode 3
Co-hosts Louise Campbell and Roger Green sit with Maru Rinella, who co-chaired the New Nomenclature process, Jeff Lazarus, who oversaw the entire Delphi process, Meena Bansal, who played a key role and co-moderated the 2023 AASLD session, and patient advocate Mike Betel to discuss the entire process from inception to today and beyond.

00:03:57 - Meet Meena Bansal
Dr. Meena Bansal, Division Chief at Mt. Sinai Hospital in New York, discusses how she became involved in liver disease and her current research interests, and shares one fact about herself that might surprise you.

00:05:47 - Groundbreaker
Panelists share one piece of good personal or professional news from the previous week.

00:08:22 - Characterizing the Nomenclature Process
Maru and Jeff discuss the original goals of the process and how focus broadened and shifted throughout.

00:16:02 - How the Delphi Process Worked
Jeff describes the overall process. Roger asks about people who chose not to participate at the outset, which leads to a discussion about the overall rate of participation. Roger then asks what might have worked better, which leads Maru, Meena and Jeff to discuss groups they wish had been better represented.

00:27:05 - The Role of Allied Health Providers
Louise asks why Allied Health Providers did not play a larger role throughout the process. Maru and Meena differentiate between providers' roles in the early process and the mechanics of rolling out to the patient community.

00:29:38 - Focusing on the Rollout
Roger's question about the rollout leads Jeff to focus on some of the key early stage events. Jeff and Maru go on to discuss the high level of participation from key journals.

00:33:32 - Early Awareness
Mike Betel brings a piece of data on physician awareness from the pre-test of a study he is conducting in Canada, which serves as a conduit into the entire topic of who is aware of the nomenclature today and how knowledge will spread over time.

00:38:56 - The New Message for Patients
Louise notes that the upcoming UK effort to bring VCTE screening to primary care will provide an effort to define and characterize the disease for patients. Meena comments that providers have done this informally for years, but while the message used to be that the patient "just has fat on the liver," this nomenclature will formalize the disease, remove "just," and focus the patient on therapy.

00:39:15 - MetALD - A New Disease in the SLD Family
Roger states that in his mind, the newly defined disease MetALD is a major positive outcome of the process. Maru, Meena and Louise each describe ways this new definition will aid diagnosis and treatment, Mike notes that the message still must be tailored for each patient.

00:43:55 - Implication for Diagnostics
The group discusses the idea that while the nomenclature will not lead to new diagnostic tests, it might lead to increased and more appropriate use of the tests that exist.

00:48:25 - The Future of the Nomenclature
Roger asks the group where this process will be in a year and five years. Answers vary.

00:51:58 - Grading the Process So Far
Roger asks panelists how they grade the process to date. Grades are high although, as Jeff notes, they are grading their own work.

00:55:27 - Business Report
News on audience metrics, the upcoming Question of the Week, next week's epidemiology discussion and this week's Vault conversation

This conversation is part of a March, 2023 interview between co-hosts Louise Campbell and Roger Green and Jeff McIntyre of Global Liver Institute, one of the guests on the S5 E2 panel. This particular conversation focuses largely on Jeff’s insights around the imminent anticipated drug approvals of obeticholic acid (which was withdrawn several months later) and resmetirom (whose PDUFA date is next month).

Jeff's 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, (S4 E5) 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.

Leading MASLD patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) describe their respective organizations' priority 2024 MASH programs to co-hosts Louise Campbell and Roger Green.

In this conversation, the advocates each describe their respective organizations' top project for 2024. Wayne Eskridge goes first, describing the Fatty Liver Foundation's annual "flagship" study, The State of NAFLD and NASH Care in America. This study, which has been going on for "a few years," surveys patients' experiences around diagnosis and treatment of their SLDs. This year, which increased focus on non-invasive testing and the anticipated availability of a MASH drug, should yield particularly interesting results. Tony Villiotti talks about the extensive "liver awareness" education work NASH kNOWledge is conducting with over 250 schools and community centers in the Pittsburgh area. As part of NASH kNOWledge's ongoing effort to communicate to children on their own level, Tony anticipates his 10-year-old grandson accompanying the team this year, dressed in a "Livvy the Liver" costume. Milan Mishkovikj discusses a program where ELPA leadership conducts liver screenings at the European Parliament in Brussels, which provides opportunities not only to teach legislators and executives about their liver disease but also to learn their own liver health status. Jeff McIntyre discusses GLI's Advanced Advocacy Academy, or A3, a program to create and educate liver health advocates across the globe. To use Jeff's phrase, the program is starting to "grow roots" and become a self-sustaining year-round activity. Louise Campbell notes that the common theme in all four programs is that they are patient-focused, and most are children-focused. 

Roger's final question is to ask what will constitute success for each organization over the next 12 months. The answers vary in specifics but carry the basic themes of education, access and drug approval common to the rest of the conversation. 

Leading MASLD patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join Louise Campbell and Roger Green to explore the roles advocacy groups might play in supporting patient access through drug information, education and advocacy processes. 

The conversation starts with Roger. He takes note of advocates' sense that they are held outside the access process and asks whether and how that might change. Wayne suggests the question itself is highly optimistic, noting that in a fragmented payer structure, the only advocate organization large enough to have impact is GLI, and he commends them for doing so. Louise comments that while patients take the medications, "they are not the market. The market is the payer." In the UK, the market is either NICE or the private insurers, and these payers look for cost effectiveness. She also notes that MASH drugs might find themselves competing against diet and exercise, incretin agonists and other interventions yet to come that are not steatosis-specific. Prescribers make decisions within the context of guidelines (what Louise describes as "ticking boxes").

Tony notes that payers are the "final frontier" in terms of communicating with patients and assessing their needs. Jeff notes that this range of access-related issues are what he described earlier as the "second half" that starts subsequent to drug approval. He notes that in the US, this relates not only to private insurers but also CMS and the VA system, since most of the early MASH patients will be older than 65. He views patient activism and advocacy as the vehicles patients can use to affect the value process and achieve wider, simpler availability to medications. Milan looks at these same questions from a European perspective, and notes that government payers care about total cost of disease. For MASH, this probably involves liver cancer more than any other disease sequel. 

As the conversation ends, Roger comments that in his past work as a pricing consultant, he always advised clients that education and communication were keys to long-term success. In his vision, a patient who does not see the value in medication will not take it. This will lead the prescriber to believe it doesn't work well and, over time, not to prescribe it. 

Leading patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join Louise Campbell and Roger Green to discuss what Jeff calls "the second half" - the hard work on coding and patient access that will follow the first MASH drug approval. 

Leading patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) discuss their expectations for life after the resmetirom PDUFA data and, with it, the potential for the first MASH drug approval, with Louise Campbell and Roger Green. 

The conversation starts with Roger noting a funny coincidence; the March 14 PDUFA data for resmetirom is Pi Day, which means the first MASH drug approval might come on the math geek's favorite day of the year. He asks panelists to describe their moods as they look forward to the event. All five other panelists Advocates describe their "guarded optimism" regarding whether resmetirom will be approved. Wayne Eskridge also notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise Campbell and Milan Mishkovikj describe how US approval might affect their respective countries and regions. Going last, Jeff McIntyre describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. When he has finished discussing the questions we might all face arouind the initial FDA ruling on resmetirom, he goes on to describe a possible approval path for countries outside the US.

00:00:00 Surf's Up: Season 5 Episode 2
Co-hosts Louise Campbell and Roger Green sit with four leading MASLD patient advocates (Tony Villiotti of NASH kNOWledge, Wayne Eskridge of the Fatty Liver Foundation, Jeff McIntyre of the Global Liver Institute, and  Milan Mishkevikj of the European Liver Patients Association) to discuss their plans and actions for MASH patients in 2024. The discussion covers the advocates' hopes and concerns for the year and the programs and efforts each considers top priority. 

00:04:09 Meet Milan Mishkovikj
North Macedonian patient advocate  Mishkovikj, a key leader in the ELPA, discusses how he became involved in liver patient advocacy and shares one fact about himself that might surprise you. 

00:11:25 Groundbreaker
Panelists share one piece of good personal or professional news from the previous week.

00:15:52 Anticipating Pi Day
Every year, Pi Day is March 14. This year, that date has extra significance: the PDUFA Date for resmetirom approval at FDA. Advocates describe their "guarded optimism" regarding whether resmetirom will be approved. Wayne notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise and Milan describe how US approval might affect their respective countries and regions. Jeff describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. He also describes a possible approval path for countries outside the US.

00:26:42 Post-Approval Planning
 As Jeff puts it, "We have to be planning for the second half while we're playing the first half on this," with essential questions about the implications of labeling on the topics he mentioned earlier. Roger asks what role patients might play in access decisions, to learn that the advocates have largely been "blocked out" of the process. GLI anticipates driving conversations with health systems around policies and access. The other US advocates do not anticipate doing so. Milan describes how ELPA will work with EMA, the European Parliament and other relevant groups. Louise adds private insurers and governmental payers to the critical post-launch lobbying and discussion targets.

00:38:43 Where Does the Patient Fit?
Roger asks where patients fit in the decision paradigms and how that might change over time. Louise shares her view that while patients might consume the medications, the real customer is either the prescriber or payer. Tony describes payers as "the last frontier" in learning how patients feel. Jeff returns to a range of "here and now" access issues GLI can address now. Milan and Roger discuss perspectives on the interplay of regulators, payers, providers and patients.

00:49:13 Advocates' Key Programs
Each advocate describes one key program they will run in 2024. Wayne describes FLF's State of NASH Care in America survey. Tony describes NASH kNOWledge's children's education programs. Milan describes continuing pilot programs ELPA started in 2023 to education the European Parliament. Jeff discusses GLI's Advanced Advocacy Academy, which "grew roots" worldwide in 2023. At different points earlier in the discussion, each advocate commended the support they get from GLI.

00:56:30 Closing Question
Roger asks what will tell each advocate whether they've been successful when they look back on 2024, 12 months from the recording date. Answers are powerful and vary by organization.

01:02:55 Business Report
News on audience metrics, the upcoming Question of the Week, next week's nomenclature discussion and this week's Vault conversation.

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this last segment of Episode 1, the co-hosts explore the complexities surrounding advertising and accessibility of metabolic agents in the US market, with a particular focus on how these factors might influence public engagement and healthcare provider education.

The tone of this segment demonstrates concern that gaps or inaccuracies in consumer information might affect patient treatment in the care pathways, as providers who may not yet be equipped to handle inquiries about newly approved liver treatments deal with issues of proper prescribing and access.

Louise Campbell starts this conversation by reflecting on the challenges and frustrations caused by price and access disparities when DAAs entered the Hepatitis C market. In her UK practice, native Egyptians went back to Egypt to purchase DAAs at £1,000, which meant that the UK care team lost control of patient information.  She highlights the importance of educating not just physicians but also allied health professionals who spend more time with patients, to ensure they can have informed discussions about new medications and their management. She proposes exploring education strategies and designing clinical pathways to support the effective introduction of new treatments. She mentions upcoming recommendations for fatty liver in Australia as an example of progress in liver health management.

Roger Green expresses interest in delving into diagnostics challenges, especially considering the rapid uptake of semaglutide and tirzepatide as weight loss drugs offered by telemedicine providers outside the traditional care paradigm. He worries about the potential this model has to leave treaters with inadequate or inaccurate knowledge of their patients, and advocates for a more educated approach by payers to include liver-aware diagnostics in metabolic disease management to better serve patient needs and prevent liver-related complications. 

Jörn Schattenberg also advocates for broader, deeper education campaigns while noting that there appear to be few if any interactions between GLP-1s and resmetirom based on clinical trial reports.

This conversation underscores the interconnected challenges of drug marketing, healthcare provider education, and diagnostic practices in the evolving landscape of liver treatment and highlights the need for a multifaceted approach to address these issues effectively.

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, the group examines the explosion of telemarketer-driven consumer advertising for GLP-1 agents as anti-obesity medicines and asks what impact this might have on diagnosis, treatment and monitoring of MASH in the US. 

Specifically, the participants discuss the potential impact and concerns surrounding the use of weight-loss drugs, including semaglutide, and the impending approval of drugs for treating fatty liver disease. They highlight the challenge of ensuring patients receive comprehensive care that includes liver health assessments, especially with the rise of telemedicine and commercial approaches to medication distribution. The dialogue underscores the necessity of educating healthcare providers beyond physicians, such as Allied Health professionals, to have informed discussions about these medications and their management.

The discussion also delves into the issues of drug pricing, the black market for medications, and the importance of proper education for all healthcare providers to prevent misuse and ensure the right patient populations are being treated. Jörn Schattenberg notes the significance of preparing for drugs that are weight neutral, addressing the obesity epidemic without exacerbating liver disease issues. He emphasizes the need for specialists to assess treatment responses and manage patient care effectively.

Roger Green expresses concerns about the commercialization of healthcare leading to suboptimal patient education and care, particularly in the context of obesity treatment. He plans to engage with payers to discuss the implications of new treatments on healthcare systems.

Louise Campbell raises questions about drug-drug interactions and the broader implications of new treatments being prescribed outside their intended patient populations. Jörn reassures that no major issues were identified in clinical trials regarding drug-drug interactions and believes that standard clinical practices can manage any potential concerns.

The conversation reflects a complex landscape of treating liver and obesity-related conditions, highlighting the need for comprehensive education, careful patient assessment, and a multidisciplinary approach to healthcare in the face of new and emerging treatments.

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, the group explores the goal of provider and patient liver education, key goals for liver awareness and the potential for direct-to-consumer advertising of GLP-1s for weight loss to garble the "liver awareness" message. 

The dialogue underscores the concern that the convenience of telemedicine and the allure of easily accessible obesity treatments might lead patients to overlook comprehensive health assessments, especially for liver disease. The conversation reveals a broader concern about the health system's ability to ensure that treatments like Novo Nordisk's weight loss drug are used responsibly and with proper medical oversight.

Louise emphasizes the importance of being "liver aware" and advocates for integrating liver health into overall health assessments. She suggests that everyone, especially those prescribed weight loss medications, should have basic liver function tests to identify any underlying liver conditions that could be exacerbated by such treatments. The discussion also touches on the dangers of the black market and non-prescribed use of weight loss drugs, highlighting the need for education and responsible prescribing practices.

The conversation shifts to the potential impact of drug approval publicity and the need for health systems to educate both patients and healthcare providers on the comprehensive management of obesity, including liver health considerations. The speakers express concern that the hype around new treatments could overshadow the importance of holistic health assessments and lead to missed opportunities for diagnosing and treating liver disease.

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, Louise Campbell describes how VCTE can serve as a behavioral monitor, Roger Green reviews some changes in the podcast this year and the group begins to discuss why "liver awareness" should become an important concept. 

As this conversation starts, a joke from Roger Green about "VCTE as lie detector" leads Louise Campbell to note that personal trainers should consider looking at "internal health" (fat in organs) instead of "external health" (general obesity). She also discusses the ability to link her digital app, MyLife365.me, to VCTE measurements.

Roger Green becomes the last co-host to discuss his last couple of months. He outlines a couple of upcoming changes in the SurfingMASH podcast, including a new "Question of the Week" segment.

After describing the new segment, Roger shifts the conversation to focus on some practical issues surrounding the potential for increased demand on the clinical care pathway once a MASH drug is approved. Jörn Schattenberg notes that we will need dramatic increases in provider education over time for them to step into an active role in the pathway. He believes that drug approval will speed this process.

Throughout the entire episode, a question re-emerges about the goal of liver education. In the past, this podcast has discussed "liver health" and "liver wellness" as if the liver is the target and goal. In this conversation (and later in the episode) the concept of "liver awareness" bubbles up. "Liver awareness" refers to appreciation of the role the liver plays in all metabolic health.5

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, Louise Campbell describes her recent efforts in enhancing liver health awareness and education, focusing on the launch of the user-friendly website MyLife365.me. Also, she shares lessons about patient communication and creating liver awareness.

This conversation combines an informal discussion on best ways to deliver information to patients with some more formal thought about good communication. The website's  significant increase in visitor metrics indicates a growing public interest in tracking one's own liver health. while expansion and uptake in multi-lingual and non-English-speaking countries suggests its versatility. Louise highlights the importance of easy-to-understand resources, such as color-coded interpretations of diagnostic results, which have made liver health information more accessible to the general public.

On issue at the outset: despite the adoption of new medical nomenclature, she notes the public's continued use of traditional terms like "fatty liver" when seeking information. 

She also shares the expansion of her MyLife365 app to countries including India and France, providing users a platform to track liver health improvements through lifestyle changes. The app's feature of visualizing liver health progress in a simple and engaging manner has been particularly well-received, fostering liver health awareness among younger demographics. Jörn contributes to the conversation by emphasizing the benefit of detaching liver health from stigmatizing factors like body weight, focusing instead on pathophysiological relevance.

The dialogue shifts to the practical applications of liver health tracking in clinical settings. Louise mentions the positive feedback from both patients and physicians on the convenience and effectiveness of using the app for monitoring liver health over time. The discussion underscores the importance of being "liver aware," promoting preventive health measures, and facilitating conversations about liver health in both clinical and everyday settings.

This conversation reflects a broader shift towards engaging the public in proactive liver health management, leveraging technology and clear communication to demystify liver disease and encourage healthy lifestyle changes. Louise's initiatives, including the website and MyLife365 app, represent significant strides in liver health education, aiming to bridge the gap between clinical knowledge and public awareness.

After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, Jörn Schattenberg describes the challenges, opportunities and experiences that he has found in assuming Department leadership  at the University of the Saarlandes. 

Jörn shares his early experiences and aspirations as the new chair of a department, emphasizing the joys and challenges of transitioning into this leadership role. He lists the department's strengths and identifies 
opportunities for growth based on his own prior experiences. 

Jörn provides specific focus on his aim of enhancing clinical trials and diagnostic capabilities within the department. He discusses the importance of building a clinical study team and ensuring that physicians have the support and time needed to engage in patient recruitment for clinical trials. 

Separately, Jörn highlights innovative patient navigation systems already in place at Saarlandes, like the pager system that enables patients to move from appointment to. appointment within the hospital seamlessly. He discusses his desire to streamline outpatient diagnostics and improve collaboration with the radiology department for advanced imaging techniques. Jörn's approach is patient-centric, focusing on better treatment options and diagnostics, and he has received positive feedback from colleagues. 

The conversation underscores the significance of leadership in driving clinical and administrative improvements, fostering a collaborative environment, and enhancing patient care through innovative practices and a focus on liver diseases.

The first episode of Season 5 of Surfing the MASH Tsunami starts with a brief discussion of what the co-hosts have worked on for the last two months and proceeds to consider the impact on patient treatment of having a MASH drug approved in the US market, particularly in today's direct-to-consumer weight loss advertising.

The conversation starts with Jörn Schattenberg discussing his first two months as a Department Chair, focusing on the transition, challenges, and opportunities he has encountered. He focuses on the satisfying challenges and opportunities he's encountered, including managing inpatient departments and enhancing the department's focus on liver-centric research and clinical practices. Significant emphasis is placed on improving diagnostic capabilities and clinical trials, highlighted by securing two major EU grants for liver disease research.

Louise's talk focuses on the launch of a new, user-friendly MyLife365.me website aimed at improving liver health. The revised website is generating major growth in traffic and has expanded beyond the world's major English-speaking marketing to France and India. Louise highlights the app's success in engaging both the general public and physicians, which can facilitate easier discussions about liver health with physicians and patients sharing easy-to-interpret, color-coded outputs.

Roger briefly discusses some of the changes coming to this podcast in 2024. One exciting element is the new "Question of the Week" segment, which is scheduled to launch later this month.

The rest of the discussion centers around some practical patient treatment issues that might arise upon the approval of a MASH drug (presumably resmetirom, coming later this year).  Some of the discussion focuses specifically on increased needs for patient identification and screening that will arise with increased consumer public relations and physician education. Roger expresses a concern that increased consumer advertising for telemedicine and local medical practices that center around prescribing semaglutide or tirzepatide over the phone will create an array of challenges for patient screening and management (possibly even accurate record keeping). The  group agrees that increasing the depth and breadth of education will be one key to success, including a broadening of targeted specialties and, as Louise points out, different provider groups.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with Global Liver Institute Vice President of Liver Health Programs Jeff McIntyre, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on Jeff's mixed assessment of 2023, focusing largely on drug approvals and the new nomenclature.  

In 2023, the field of fatty liver disease experienced both setbacks and progress, encapsulated in Jeff's phrase, "Two steps back, one step forward." Central issues included drug approval processes, nomenclature changes, and advancements in understanding and treating Non-Alcoholic Steatohepatitis (NASH). The year was marked by significant efforts to address fatty liver disease, but results were mixed, partly due to the complexities and inefficiencies in the drug approval process.

A notable moment was the FDA Advisory Committee's review of obeticholic acid, which highlighted issues with the clarity and reliability of the FDA's drug approval endpoints. This process was perceived as bureaucratic, sometimes disheartening, and not always effectively engaging with patient communities. Jeff underscores the importance of enhancing communication between various stakeholders in healthcare, including medical societies, patient communities, and regulatory bodies.

The conversation also reveals a consensus on the need for more involvement of patients and nurses in decision-making processes. Jeff stresses the necessity of educating the FDA about liver disease and the impact of drug approvals on patient safety, advocating for a stronger voice for patients and nurses in redefining the FDA’s approach to safety.

Roger adds to the discussion by expressing concerns about institutional risk aversion in regulatory processes, which can impede drug approvals. He points out that some FDA committee members lack basic knowledge about fatty liver disease, leading to naive questions and decisions. Louise highlights the reclassification of fatty liver disease as metabolic dysfunction and its potential benefits, suggesting that integrating liver disease treatment within endocrine and cardiology care could be beneficial due to the interconnected nature of these fields.

Looking ahead to 2024, Jeff anticipates positive developments in drug approvals and increased patient involvement. He notes the change from International NASH Day to Global Fatty Liver Day, indicating a shift in nomenclature and expectations of more patient engagement in regulatory discussions and decision-making processes.

In conclusion, the conversation reflects a blend of optimism and caution regarding the future of fatty liver disease treatment. The importance of patient-centered approaches and collaborative efforts among healthcare stakeholders is emphasized, highlighting the ongoing need for patient advocacy organizations to play a significant role in navigating the complexities of the disease. This includes dealing with the challenges posed by the new nomenclature and the potential for new treatments. The dialogue underscores the necessity for a more integrated, patient-focused healthcare system that prioritizes the perspectives and needs of those directly affected by fatty liver disease.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with Ukraine Public Health Executive Tatiana Deshko, Mike Betel of the Fatty Liver Alliance and co-host Roger Green. The conversation focuses on how the last six months of the Ukraine war have affected public health challenges and citizen morale and how continuing foreign aid from the US and Europe affects that morale.  

This conversation focuses on how the last six months of war have affected citizen morale and, concurrently, an evolving and increasingly challenging healthcare landscape. The conflict continues unabated, causing substantial loss of life, disrupting daily routines, and imposing severe strains on the healthcare system. Despite the hardships, Tetiana explains, the Ukrainian people remain steadfast in their commitment to freedom and democracy, even as they face exhaustion and depleted resources.

The healthcare crisis that Tetiana outlined in Season 4 Episode 28 has escalated due to the rising number of wounded and, concurrently, an acute shortage of human resources to address the expanding health needs. The number of available healthcare professionals keeps diminishing as many have been called to military service. 

To counter these challenges, Ukraine has pivoted towards innovative solutions, including telemedicine and artificial intelligence. These technologies play a crucial role in offering health advice, particularly for chronic conditions such as HIV, hepatitis, and tuberculosis. They help by simplifying patient pathways, expediting diagnostic processes, and ensuring timely treatments in a resource-constrained environment. But while international support for telehealth initiatives is significant, \ language barriers remain a substantial challenge to effective care delivery.

The ongoing conflict complicates the ability to address non-urgent health issues like metabolic diseases. The war has also led to a surge in stress-related diseases, mental health issues, and suicides, especially among the youth in urban areas. All this leads to declining health attention and general health among Ukrainians.

This conversation underscores the dire situation in Ukraine, where the healthcare system struggles constantly to adapt to the demands of war. There's a pressing need for mental health support and an increase in stress-related illnesses. Telemedicine has become a critical tool for connecting displaced patients with healthcare providers. However, language barriers and the vast healthcare needs present formidable obstacles.

These war-related challenges to Ukraine's healthcare system are profound. The dedication and resilience of healthcare professionals like Tetiana are pivotal, but the entire system also relies on vital support from the international community. International support is particularly key in certain inventive healthcare delivery solutions, including implementation of mobile clinics and efforts to establish prosthetic centers. These challenges are particularly acute in occupied territories, which lack healthcare infrastructure. Additionally, new warfare tactics like the use of mines and tear gas have introduced further complications, increasing the need for specialized care and support, including for blinded veterans.

Despite these difficulties, there is an enduring spirit of resilience and resourcefulness. The Ukrainian people and healthcare professionals keep adapting to these unprecedented challenges, showing remarkable ingenuity in finding solutions. While the road ahead is fraught with complex obstacles, there is hope that the current turmoil will lead to development of a more robust and resilient healthcare system in Ukraine. The continued commitment to a free and democratic Ukraine, boosted by innovative healthcare strategies and backed by international support, underscores the nation's determination to overcome these adversities.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with Novo Nordisk International Medical Vice President Michelle Long, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on advances in research, collaboration and insight creation the entire MASLD research community has made in 2023 and what this new perspective portends for the future of MASLD research.

Michelle starts by using the word "momentum" to characterize the MASLD research community in 2023. She says the pace of change makes it impossible to summarize or describe the year easily, For example, the adoption of new nomenclature came six months ago at EASL, but it feels like it was far longer than that. Roger compares the optimism in the field to 2019 while awaiting what was the anticipated approval of OCA. Today, he notes,  the entire community understands so much more about MASLD and has so much more confidence in resmetirom than in OCA that we see optimism about future drug developments along with a greater appreciation of the potential scale of the global crisis around MASLD. 

Michelle comments that in the aftermath of OCA, the scientific community has been "willing to adapt and eat humble pie." Today, we see proposals for future studies that demonstrate how fast researchers are adopting new knowledge and using it in new study designs. In particular, she notes that the year's FDA workshop showcased a shift in drug development strategies and a deeper understanding of surrogate endpoints, reflecting a desire within the field to embrace new insights for advancement.

Louise adds to the dialogue by discussing the swift adoption of new terminology and the integration of noninvasive diagnostic technologies, emphasizing the patient's perspective and the importance of comprehensible communication about their health condition. She advocates for broader inclusivity in future Delphi processes, specifically seeking greater involvement for nurses and allied health professionals, groups that provide line communication with patient communities. 

Roger notes a newfound humility within the academic medical community that promotes collaboration and ongoing improvement. Michelle agrees, stressing the need to dismantle barriers such as pride and the critical role of cross-sector collaboration in addressing the field's unmet needs and the lack of approved therapies. She designates 2023 as a turning point, with a shift toward a more open, conservative, and cooperative mindset in the scientific community, departing from previous attitudes.

The discussion moves to the intricacies of interpreting histology data from clinical trials, where Michelle points out the importance of a nuanced understanding of such data, including the timing of biopsies and the correlation with noninvasive testing results.

As an example of the new nuances, Roger cites bariatric data shared at EASL suggesting that it takes five years for the liver fat reduction associated with bariatric surgery to translate into a one-level regression of fibrosis and a HistoIndex study suggesting a consistent "true" placebo rate of 34%, which is far higher than we see in drug studies.   Michelle acknowledges that aligning the ideal scientific method with business realities is a pivotal, realistic challenge. The group concludes with predictions for 2024, expecting significant advancements, possibly including new therapy approvals. Despite potential obstacles, there is a shared optimism for rapid progress and enhanced collaboration in hepatology research and clinical practice.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with biotech entrepreneur Rachel Zayas, Founder and CEO of AGED Diagnostics, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on AGED's progress in 2023, what Rachel has learned about fundraising and creating winning pitches, and what she anticipates for her company and the entire MASLD community in 2024. 

The discussion begins with Rachel, like most other participants in this series, highlighting the FDA decision on resmetirom, anticipated by March 14, 2024, as a breakthrough event for the MASLD community. She expects this will lead to a breaking down of traditional silos between medical fields, fostering a more integrated approach to healthcare. She already sees greater participation from other metabolic specialties in hepatology-related discussions and conferences.

Roger, intrigued by her comment, inquires about the specific forums facilitating this interdisciplinary engagement. Rachel responds that she sees small numbers of such specialists today but believes this foreshadows a growing trend.  

The conversation then pivots to potential challenges facing the hepatology field in 2023. Roger asks Rachel whether she has seen any impact from the FDA's non-approvable letter for obeticholic acid on her segment of the investor community. Rachel states that the early-stage investors she courts assume high risk in their investments and, if anything, seem more likely to commit based on what the community is learning from burgeoning amounts of high-quality academic and commercial research.

Louise joins the discussion by highlighting the evolving landscape of healthcare investment. She emphasizes the significance of improved tracking mechanisms, noninvasive techniques, and adaptive FDA approaches. Louise advocates for a more inclusive approach in hepatology, suggesting increased participation in broader medical conferences to bolster interdisciplinary collaboration.

Turning to AGED Diagnostics, Rachel shares her team's advancements in research and development, particularly their work on a multi-site pre-clinical trial focusing on liver disease biomarkers. She outlines her team's objectives and expectations for the upcoming year, highlighting significant progress in their research endeavors.

The conversation also touches on Rachel's experiences with early-stage investors in the life science space. She notes their growing interest in hepatology, especially in noninvasive diagnostic tools for liver fibrosis and MASH. This shift in investor attention streamlines her pitching process, allowing her to focus more on developing AGED's technologies and solutions her team offers.

Looking ahead to 2024, Rachel anticipates the hoped-for resmetirom approval as pivotal. She also predicts an increased demand for noninvasive tools to monitor MASH progression and regression, foreseeing a rise in supply and demand for such tools once a therapeutic solution is available. She estimates that between 2025 and 2027, more tools in this area will emerge,

In closing, Roger asks about potential storm clouds and bright spots Rachel sees. She notes that payer approvals might constitute a logjam. Roger suggests that diagnostics that tell us which patients benefit from therapy will provide the best defense against such a logjam. In contrast, Louise suggests that the lack of education among allied health professionals might become another obstacle in implementing new treatments and diagnostics. She emphasizes the need for adequate frontline delivery systems to support the introduction of new medical solutions.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with Global Liver Institute Founder and CEO Donna Cryer, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on Donna's personal health challenges in late 2023, what her absence revealed about the strength and depth of the GLI team, and what she foresees as major challenges for 2024. 

The conversation starts with Donna discussing a major medical event in her life during the last few months in 2024, one during which, in her words, "I almost died." She speaks briefly but clearly about the nature of the event itself, as well as how and why she is rebounding to full strength. Donna goes on to describe how well the GLI team performed in her absence and the various forms of feedback she received confirming this. In response to a question from Louise, she notes that building a strong team has always been her priority at GLI and cites several past examples where the team has led while she assumed other roles and challenges. 

From here, Donna notes a major change in 2023: the evolution from being a liver community to what she describes as "a community that cares about the liver," a multi-specialty, multi-stakeholder group focused on the wider implications of liver disease and patient and public health. As examples of this broader community, she cites the common guidelines from AACE and AASLD, conversations with payers and a willingness from other liver disease groups to share capabilities with the SLD community. She goes on to note that none of this change happens quickly, but that in the 10 years since GLI was formed, the scale of change has been consequential.

The discussion turns toward the process of nomenclature change. Donna notes her concern throughout the process that some important implementation steps were not being considered on as timely or thorough a basis as she would have hoped. Specifically, she cites the issue of ICD codes and the need to involve primary care providers and organizations into the key processes. Louise Campbell agrees, noting the challenges around bringing wider use of VCTE into the UK system even after NICE has accepted the need to do so. 

Donna notes that this is the reason that GLI is calling its annual event Global Fatty Liver Day, not to be "recalcitrant, but because, as a global organization, we recognize" that not all parts of the world have adopted this nomenclature. She anticipates using what she calls "bridging documents" so that people using different nomenclatues can explain the same processes. 

From here, the conversation transitions to cover the growing momentum and energy in the patient and advocate communities, as evidenced by general energy and Roger's experience (along with Mike Betel) of getting pushed out of overflow rooms for patient sessions at AASLD (listen to E50.2 for more details). Finally, the conversation returns to the value of the MetALD classification, some issues around Donna's recent health scare, and a promising view of the future.

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with patient advocates Neeraj Mistry of the Fatty Liver Foundation and Jenn Leigh Jones of the Society for Sober Liver Survival, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on the joining of their organizations and ways the new nomenclature affects how providers and patients look at Steatotic Liver Disease.

The conversation starts with Roger asking Neeraj and Jenn to provide a word of phrase that sums up the MASLD space at the end of 2023. Neeraj offers two words: "inclusivity and solidarity." "Inclusivity" refers to liver disease moving from being a "marginal issue" compared to other diseases to the center of the conversation. "Solidarity" refers to a commitment between providers, patients, corporations and advocates all to present a similar message based on the new nomenclature and the breadth of disease. Jenn's two-word phrase is "amor fati," a term coined by the Stoics and advanced by Nietzsche, meaning "love of one's fate." To Jenn, this means accepting one's past and learning from it. To convey this message, she tells her own story movingly, using the metaphor of a turtle. 

Neeraj moves ahead to describe the patient experience as "many etiologies, one journey," and then to list the items that patients need on this journey: "care, support, treatment, access when available. And for those who are at risk, we need preventative intervention." For most liver diseases, he continues, the interventions are similar, sometimes identical. The new nomenclature creates a new, broad umbrella under which providers and advocates can create an "echo chamber" for common solutions. The new nomenclature provides this. Jenn adds that much liver disease results from mental health issues, regardless of the specific etiology. One of the sounds from the echo chamber needs to promote understanding of these issues. 

Louise questions whether providers see the same inclusivity as patients and advocates. She cites her experiences in viral hepatitis, where providers tended to see patients from different geographic backgrounds or ethnicities as facing different challenges, and nurses as the patient advocates within the healthcare system to promote inclusivity. 

Roger shifts to focus on stigma, specifically the idea that the counterpoint to inclusivity is the idea that people who feel stigma tend to look for someone suffering under greater stigma, which means that patients whose primary issue is alcohol look with disdain on those whose primary issue is diet, and vice versa. He adds that Hannes Hagstrom stresses the idea that all liver disease is on a spectrum (S4 E50.5). Neeraj notes that stigma and mental health challenges lead to habits that become addictions that become tremendously hard to overcome. 

The discussion about stigma progresses in several directions: how it affects different stakeholders differently and the pivotal role of allied providers (Roger), how stigma represents a "tower of shame" and the importance of allied providers' empathy in overcoming shame (Jenn), the diverse skills and team treatment of mental health patients in NHS (Neeraj), and how viable models exist today (Jenn).

Roger notes that others in the system say that technology must be a pivotal part of the solution, given the lack of time available to doctors. Neeraj emphatically disagrees, noting that technology cannot be empathetic and that healing relies on interactions between people. Jenn concurs, noting that many patients in this system have relatively limited technological abilities or access beyond their cellphones.

The discussion closes with a question about 2024 and expressions of optimism and hope from the entire panel.