Surfing the MASH Tsunami

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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. 

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Surfing the MASH Tsunami continues its 2023 wrap-up conversations with hepatology researcher, key opinion leader and 2023 UEG Rising Star of the Year Hannes Hagstrom, along with co-hosts Louise Campbell and Roger Green. The conversation focuses largely on issues in diagnostics and clinical care pathways.
The conversation starts with Hannes describing highlights of 2023 as positive drug trials, excellent in-person meetings and the new nomenclature. Asked to clarify, he focuses on how the new nomenclature focuses on the interaction of alcohol consumption and what was previously called "non-alcoholic" disease. As a second point, he discussed the ability to use non-invasive tests (NITs) as a replacement for biopsy, if not entirely appropriate today, at some point in the near future.

Roger asks Hannes whether he has seen an impact of defining MetALD as a separate disease and including alcohol on the steatotic spectrum, he says he has not seen much yet, perhaps a little confusion about the new name (which he sees as necessary in any transition and appropriately timed now. 

Roger asks Hannes whether he sees any "storm clouds" in 2023. Hannes sees two points for concern: the pace at which regulatory agencies acknowledge the value of NITs in diagnosis and early signs of confusion around clinical care pathways. 

To Hannes, the entire community should prioritize simplification and streamlining to the degree possible. For example, primary care practitioners (PCPs) will send diabetes patients to ophthalmologists to test for retinopathy, after which the specialists will take responsibility for the specific condition but leave basic care to the PCP. He questions whether hepatologists have the bandwidth to play a similar role. Roger notes an earlier discussion (S4 E50.3), in which Naim Alkhouri mentions PCPs' concern that hepatologists will "steal" total care of the MASLD patient. Hannes notes that European systems do not operate this way. Louise comments that in the UK, 95% of all scans require no new treatment, which means that a nurse-based system can pinpoint challenges and spread workload among appropriate specialties.  To her, this makes pathway development "absolutely key." 

Hannes asks Roger for historical context on this issue. Roger suggests that acceptance of the importance of MASLD feels to him similar to the final acceptance of the cholesterol hypothesis in the 1980s, but in terms of drug development and treatments, more like hypertension in the 1950s when there were multiple modes of action available, none of which were efficacious for most patients as monotherapies. He also notes that we do not know which care paradigms will hold (his example: oncology, with its induction vs. maintenance drug choices and cycles). 

He notes the group is looking at many issues, most of which focus on prediction modeling and treatment response. One project he describes focuses on providing a prediction model that is meaningfully superior to FIB-4 and is based on primary care practices, not clinical trial groups. He also describes work on "emulated target trials," in which the researcher can compare historical data to current clinical trials using advanced statistical techniques. The goal here is to create comparisons on a range of questions, including intention to treat and protocol effects. Finally, Hannes mentions beginning work on treatment response markers, where his team is in the early stages, partly because there are no approved drugs to support these analyses in a larger population. 

In 2024, Hannes sees potential "game changers" as coming not only from drug development (and hopefully approvals), but also work on diagnostic markers and new kinds of multi-center, multi-region collaborations that will create larger, richer and more diverse data sets than researchers have today.