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Arizona Liver Health Institute V.P. of Academic Affairs and Fatty Liver Program Director Naim Alkhouri and Global Liver Institute Founder and CEO Donna Cryer join Louise Campbell and Roger Green to discuss their recent projects and accomplishments. Each of them brings newsworthy stories that lead to thoughtful, stimulating conversations about a range of issues.

Naim Alkhouri's news includes two recent academic publications and some exciting, innovative new projects. One of his publications, the EDICT trial, contrasted two sets of T2D patients that were treated with different regimens. One set was treated with a "classic" regimen of metformin, a sulfonylurea and insulin -- agents that are liver-neutral or problematic. The other set was treated with a more friendly regimen of pioglitazone, a GLP-1 and metformin. Not surprisingly, when patients in the two groups were evaluated, the differences were dramatic. The other paper was a collaboration with the Pfizer NASH team, looking at 10,000 NHANES patients who were evaluated using FibroScan to estimate the proportions of NAFLD and NASH in the population. The numbers here were consistent with public health estimates. One interesting point: the CAP threshold the researchers used in this paper was far different from what Louise uses when evaluating patients with Tawazun Health. The difference? Louise chooses lower levels in the belief that lower levels will motivate more patients towards self-care, while Naim's higher levels reflect the score at which physicians are likely to prescribe medications. This led to a conversation on the value of this two-metric approach: one level for self-care and a higher one for medication. As Roger notes, this aligns with the concept of "prehypertension" that has him taking steps to reduce his blood pressure slightly without the aid of medication. Naim goes on to discuss two novel sets of studies he is conducting, one with the diet app Noom and the other with a range of digital therapeutics companies.

Donna Cryer begins by announcing she has three pieces of news to report: a recently released paper supported by Novo Nordisk and developed with a group convened by the National Committee for Quality Assurance, titled "A Rallying Cry: Improving Coordinated Care for People with Nonalcoholic Steatohepatitis," a scientific statement from the American Heart Association on the connection between NASH and cardiovascular disease, and the formal launch of GLI's "Liver Health is Public Health" campaign. The NCQA paper and entire idea of liver health as public health launch spirited conversation with emphatic agreement among the three participants. When Roger shares some thoughts from Naim's conversation about the potential for digital heath apps to become personalized and tailored over time, it leads Donna to a fourth announcement about a talk she is giving next week at the University of California Health System on the use of data for the public good. As with Naim, the conversation turns to the use of digital health in its many forms to improve liver care.

Combined with the Episode 20 conversation with the three permanent Surfers, this episode connects the many streams of Fatty Liver research into a single package that is part pharmacotherapy, part better diagnostics, part digital health and part public policy.

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Surfing the NASH Tsunami's "Seasons" start with the calendar year, but our first episode posted on April 15, 2020. As we begin our third year, we wanted to give listeners a chance to get to know Jörn Schattenberg a bit differently than you would just from listening to episodes. Jörn discusses how he decided to become a hepatologist, why Stephen Harrison's phrase "Greet 'em and Street 'em" has such resonance, the basic science work his laboratory in Maïnz does, and where he sees the podcast fitting into the future of Fatty Liver disease. Louise Campbell and Roger Green ask questions and share viewpoints in this fast-moving conversation.

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This conversation starts with Stephen Harrison discussing the scope of current NITs in the context of what NAIL-NIT needs to achieve. "We don't need to reinvent the wheel, " he says, "only to make it run smoother." After Naim Alkhouri and Mazen Noureddin discuss the Phase I facilities they are building for future research, the group closes the conversation by focusing on the medical, commercial, financial and patient-centric imperatives that make it so imperative to develop appropriate NIT-based solutions for drug development, diagnosisis and patient management within the next five years.

This week marks the 2nd anniversary of Surfing the NASH Tsunami! Thank you for being part of the process that has brought us this far: 126 episodes and 335 separate podcast postings and over 58,000 downloads by individuals in over 105 different countries! We promise you this: the best of NASH Tsunami lies ahead of us.

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This conversation starts with discussing how challenging it was to develop initial FDA test criteria for evaluating NASH drugs. Many years later, he notes, we have learned how flawed these criteria were, several in ways we cannot fix, but we need to do better. He relates this to what the British author Rupert Sheldrake describes as "morphic resonance" or mysterious telepathy type interconnections between organisms and collective memories within species. Once thing leading hepatologists have learned is that you can look at a liver or liver data and get a clear since you are looking at NASH, but it is harder to generate and vet consistently clear data on this point. He points to the REGENERATE trial as a place where specific data analysis did not reflect the gestalt impression and says, “that is what we need to get beyond.”

Louise Campbell interjects a very different kind of question, asking whether the NAL-NIT analyses can include questions that patients answer on initial screening in pursuit of AI-driven analyses of these questions to screen patients into or out of further tests..an idea that draws an immediate, enthusiastic response from Naim Alkhouri. In the end, the discussion turns light-hearted and focuses on how many papers the panelists will have to produce in the first year of the program.

This week marks the 2nd anniversary of Surfing the NASH Tsunami! Thank you for being part of the process that has brought us this far: 126 episodes and 335 separate podcast postings and over 58,000 downloads by individuals in over 105 different countries! We promise you this: the best of NASH Tsunami lies ahead of us.

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This conversation starts with Naim Alkhouri and Jörn Schattenberg defining the wealth of data resources and hypotheses they are bringing to their roles as co-leads of retrospective analysis for NAIL-NIT. Mazen Noureddin then asks each of them to describe his "passionate first project." This leads Naim to discuss drug evaluation principles he finds so counterproductive that they fit into Nassim Taleb's definition of "IYI" ("Intellectual Yet Idiot"). As the discussion ends, Roger Green ties this issue to the analytical fallacy of quantifying a soft qualitative measure for drug evaluation purposes and Mazen points out that we will need to expand patient evaluation to NIT-only rules in order to recruit enough patients for all the drug trials on the horizon. 

This week marks the 2nd anniversary of Surfing the NASH Tsunami! Thank you for being part of the process that has brought us this far: 126 episodes and 335 separate podcast postings and over 58,000 downloads by individuals in over 105 different countries! We promise you this: the best of NASH Tsunami lies ahead of us.

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In this brief conversation, Stephen Harrison discusses the exciting goal and ambitious research plan for NAIL-NIT, after which Mazen Noureddin describes the patient-focused issues and conference conversations that motivated Stephen and Mazen to form and recruit members for this consortium. It is a short but rich listen that will help you understand exactly what NAIL-NIT is driving to accomplish. 

This week marks the 2nd anniversary of Surfing the NASH Tsunami! Thank you for being part of the process that has brought us this far: 126 episodes and 335 separate podcast postings and over 58,000 downloads by individuals in over 105 different countries! We promise you this: the best of NASH Tsunami lies ahead of us.

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This week marks the 2nd anniversary for Surfing the NASH Tsunami! This conversation celebrates our anniversary and brings news about the formation of a new company dedicated to using podcasts and related media to put big dent in Fatty Liver disease and changing roles for co-founder Stephen Harrison and "fifth Beatle" Jörn Schattenberg.

Before you listen, you might want to join us in the "Stephen Harrison Drinking Game." Get a cup or glass of coffee (hot or iced, as you prefer), feel free to add a non-dairy milk and low-glycemic index sweetener if you need to. Then write down a "Harrisonism" (a distinctive phrase commonly associated with Stephen). Then listen to this conversation to see whether any of our panelists (Stephen, Jörn, Louise Campbell, Mazen Noureddin, Naim Alkhouri and Roger Green) select the same phrase you did.

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This 2nd Anniversary episode focuses on what the retrospective analysis from the NAIL-NIT consortium can achieve in terms of driving the shift beyond the biopsy in NASH diagnostics while simultaneously celebrating Stephen Harrison's contribution to the podcast while announcing that Jörn Schattenberg will become our weekly Key Opinion Leader (other commitments will force Stephen Harrison miss roughly half the episodes).

The first part of the discussion focuses on Stephen's role in the podcast, culminating in what SurfingNASH's audio engineer, MiC Wilson, has dubbed "The Stephen Harrison Drinking Game." (Listen to learn about it.)

Stephen begins discussion of NAIL-NIT by describing what triggered this effort - a chance to "break down stovepipes" (Harrisonism) to create a multi-study data set that can address some of the biggest issues we face today around NITs.  "We want to find the right tests for the right situation at the right time to answer the right question" whether that's diagnosis, monitoring for therapeutic efficacy or  prognosis." 

Stephen then describes a two-step process: (i) Analysis of retrospective data from completed and existing clinical trials, which should provide guidance, followed by (ii) a prospective study that can "nail" the right NIT for each situation within the next 5-6 years.

Mazen discusses the patient perspective: what happens for the patient (and physician) who clearly has NASH (maybe even F3) but cannot get into a trial because the biopsy does not reveal presence of ballooning? Over time, casual discussions about this issue with Stephen led them to drive the NAIL-NIT initiative. Mazen goes on to note the valuable work that LITMUS, NIMBLE and the Goldmine project at UCSD have done, but feels that this is the time - and NAIL-NIT is the project - to pull all this together into a focused, eventually conclusive effort. 

After Naim and Jörn discuss their motivation to participate,  Mazen shifts the tone of the conversation by asking each of them to describe his "passionate first project." Naim's answer focuses on thresholds that correspond to histological responses for the different NITs. Jörn focuses on questions of effect size, particularly related to varying placebo responses across  different trials.

Naim then goes on to quote Nassim Taleb, author of the recent book, "Skin in the Game," on a concept he describes as "IYI", "intellectual yet idiot". Naim provides two examples of IYI in NASH trials. Example 1:  an F3 patient cannot be enrolled in a trial due to lack of balloon hepatocytes. As Naim notes, F3 is "aggressive disease," so, he asks, "what else do you need to know?" Example 2:  a 0 score on ballooning is required to describe a patient's NASH as having reached resolution. 

Mazen notes that in a future with 10-15 Phase 3 trials, we will never generate the requisite sample sizes if trials are tethered to biopsy and ballooning. Stephen cites the English author Rupert Sheldrake on the concept of "morphic resonance." Here, it means that you can know something is NASH even if specific metrics do not prove it. 

After Jörn discusses the project's ability to shape the prospective trial, Louise asks whether the group plans to analyze presenting symptoms. She points out that a goal of research should be to develop a questionnaire a primary care physician can administer to the patient that will point those at higher risk toward additional evaluation.

From there, the discussion focuses on other implications of the trial on drug development and patient diagnosis and care. There is not enough room to describe all of it. Listen on to learn why a 5-year timeline to get the answer both makes sense and might be imperative.

Make sure to allow the energy and "get it done" (another Harrisonism) tone

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This week's episode and conversations preview the inaugural Innovations in NAFLD Care Workshop, premiering in Barcelona on May 6 and 7. Surfing the NASH Tsunami is a Media Partner for this conference. We will be conducting and posting interviews from the conference, co-host Roger Green is moderating a panel there, and Surfing NASH will present a follow-up episode on Wednesday, May 11.

This conversation previews Sessions 4, 5 and 6, which comprise the bulk of the Day Two Agenda. The overall theme of the day is that NASH treatment is integrated and multifactorial. The day starts with Jeff Lazarus discussing Comprehensive Care Models for NASH, the path there and desired endpoints. The rest of Session 4 focuses on two forms of technical support: integrating non-invasive tests for NAFLD into clinical practices outside the liver space and looking at the power of apps to transform the weight management process. Session 5 focuses on pharmacotherapy, including use of current pharmacotherapy in weight loss and diabetes and some of the future agents that will come into use over the next few years. Finally, Session 6, which Roger Green will moderate, pulls together a diverse set of panelists to consider the NAFLD/NASH Roadmap in the context of social media and digital transformations. Listening to this conversation provides a clear sense of how broad the scope of Day Two issues will be.

In the interest of time, this summary does not list the names of the speakers giving each talk. This is an absolutely first-class global faculty. If you are curious, go to the meeting program to learn who these exceptional speakers are.

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This week's episode and conversations preview the inaugural Innovations in NAFLD Care Workshop, premiering in Barcelona on May 6 and 7. Surfing the NASH Tsunami is a Media Partner for this conference. We will be conducting and posting interviews from the conference, co-host Roger Green is moderating a panel there, and Surfing NASH will present a follow-up episode on Wednesday, May 11.
This conversation focuses largely on Session 3 of the Innovations in NAFLD Care 2022 Workshop and the Patient Organizing Session that starts Day Two.

Session 3 focuses on the role that different types of health professionals will need to play for a successful attack on the coming NASH pandemic. Specifically, it looks at differences between what primary care physicians, nutritionists and bariatricians can achieve. The first two talks are expected to touch on structural issues and well as individual patient care. The bariatrician talk will present study data and devote significant attention to practical uses of endoscopy and non-invasive tests to track and demonstrate progress.

Before the discussion shifts to Day Two, Roger Green asks the co-chairs what they hope listeners will take away from Day One. Answers focus on two related issues: the scale of the NASH pandemic and how much impact health professionals can have for individual patients.

The rest of this conversation revolves around the importance of patient organizations both in motivating and educating individual patients and in driving broader social change around liver health issues.

One of the gaps in diagnosis and treatment is the question that different specialists need guidance to appreciate the roles they can play in the process. This session discusses the role that primary care physicians, nutritionists and bariatricians each can play on diagnosing and treating NAFLD and NASH patients.

The primary care discussion focuses on what is feasible for a primary care physician in a time-constrained environment to achieve in terms of NASH. The nutritionist point of view looks at both individual and structural issues. The individual issue is exactly what it sounds like -- wayss to support individual patients during liver workups. The structural issues address food insufficiency and poor dietary choices. The bariatric discussion will focus not only on population studies, but on practical use of different interventions and NITs to be certain that these interventions are having desired effect on the bariatric patient's liver.

In the interest of time, this summary does not list the names of the speakers giving each talk. This is an absolutely first-class global faculty. If you are curious, go to the meeting program to learn who these exceptional speakers are.