Surfing the MASH Tsunami

Send us Fan Mail

For the first time, Surfing NASH takes a deep dive into the prospect of digital therapeutics, their ability to drive outcomes and the critical success factors for proper use and deployment. This is an increasingly apt topic which intermittently surfaces on the podcast but has never featured at the center of conversation. The Surfers are joined by Naim Alkhouri and two new guests with prominent focus in this space: Joe Rubinsztain, CEO and Co-Founder of ChronWell, and Mark Berman, CMO of Better Therapeutics.

In this session, the group continues to discuss the benefits behind having an app where patients are in command of their wellness journey. Roger Green prompts Mark to further detail the Better Therapeutics product deployed in the feasibility study of cognitive behavioral therapy for improved liver health. Mark confirms that the product used was effectively the same which was used in their trial to demonstrate meaningful changes in blood sugar control for Type 2 diabetic patients. He reiterates the behavioral similarities that often underlie cardiometabolic conditions. Their thesis is that with the right support or therapy to address these behaviors, we can target multiple conditions simultaneously. Mark explains that the challenge therein lies in demonstrating from a regulatory perspective that this is an evidence-based form of prescriptive therapy.

Louise spurs comments around the idea that transparency in patient participation is enhanced when levels of comfort and trust for a process are high. She goes on to describe an app she is developing called MyLife365.me. This is a free lifestyle app that tracks how your daily life choices of food, drink and exercise impacts your liver health.

While this session features ideas around both the enormous potential and daunting challenges behind the world of digital health and digital therapeutics, the panelists provide rich insights which remain optimistic. These are big questions with far-reaching implications for the future of medicine. If you enjoy this topic and would like to learn more, we kindly invite you to leave a review on your preferred listening platform. We also encourage our audience to write us questions to include your on-ground experiences and ideas in the weekly discourse. Thank you for your continued support - stay safe and surf on! 

Send us Fan Mail

For the first time, Surfing NASH takes a deep dive into the prospect of digital therapeutics, their ability to drive outcomes and the critical success factors for proper use and deployment. This is an increasingly apt topic which intermittently surfaces on the podcast but has never featured at the center of conversation. The Surfers are joined by Naim Alkhouri and two new guests with prominent focus in this space: Joe Rubinsztain, CEO and Co-Founder of ChronWell, and Mark Berman, CMO of Better Therapeutics.

In this conversation, Joe details the inception of ChronWell and the company’s mission of assisting providers and insurers to deliver optimal care beyond the medical practice with teams empowered by scalable technology. These compounding ideas originate in the advent of electronic health records in the 90s. At the time, many failed to understand the utility in transitioning from paper to digital. Today, the potential of digital health burgeons with opportunity. Joe envisions a future where “computers are treating simple, delimited diseases in a well designed pathway which is augmenting the ability of a doctor to deliver.” He goes on to discuss the role of insurers in this future and explains the nuances which align ChronWell’s identity as a digital platform. Jörn Schattenberg commends the term “augment” because of the need to leverage all tools available in identifying the swathes of unmet patients.

Joe highlights that ChronWell is partnering with both primary care providers and specialists to build understanding around the full spectrum of disease. When considering new generation tools to treat conditions like NAFLD and NASH, he asserts that “we need to think broadly about activating the ecosystem” and removing any friction for the health care provider to utilize. This leads Naim to comment on the importance of still striving to find solutions for all Fatty Liver patients and not just those with clinically significant fibrosis. 

...

If you enjoyed this episode and would like to learn more about digital therapeutics, we kindly invite you to leave a review on your preferred listening platform. We also encourage our audience to write us questions to include your on-ground experiences and ideas in the weekly discourse. Thank you for your continued support - stay safe and surf on! 

Send us Fan Mail

For the first time, Surfing NASH takes a deep dive into the prospect of digital therapeutics, their ability to drive outcomes and the critical success factors for proper use and deployment. This is an increasingly apt topic which intermittently surfaces on the podcast but has never featured at the center of conversation. The Surfers are joined by Naim Alkhouri and two new guests with prominent focus in this space: Joe Rubinsztain, CEO and Co-Founder of ChronWell, and Mark Berman, CMO of Better Therapeutics. 

Naim leads this conversation by elaborating on his involvement in a feasibility study with Better Therapuetics on use of Cognitive Behavioral Therapy for improving liver health. Mark and his team partnered with two of Naim’s clinics to conduct the study over the course of three months. Their aim was to recruit participants from a specialty clinic setting who exhibit a range of Fatty Liver disease states and develop data to understand the effects of their therapies on the liver and cardiometabolic condition. Naim discusses why they chose targeting MRI-PDFF as a primary outcome measure. He explains that while a 90-day window is restrictive in terms of identifying fibrosis improvement, changes in AST and ALT were examined in addition to analysis of FibroScan metrics. It’s noted that increased engagement with the app correlated with improved weight and liver enzyme values. Naim goes on to share ideas around implementing combination therapies which harness the unique utility of digital apps with agents like resmetirom or semaglutide. From here, the session opens up to impressions and questions of the other panelists. Jörn Schattenberg highlights quality of life as a valuable endpoint and Louise comments on the benefit behind what’s described as a “non-medical” approach where patients are in command of their wellness journey. Roger Green asks Mark to expand on the premise and deployment of Better Therapeutic’s curated cognitive behavioral therapy.

...

If you enjoyed this episode and would like to learn more about digital therapeutics, we kindly invite you to leave a review on your preferred listening platform. We also encourage our audience to write us questions to include your on-ground experiences and ideas in the weekly discourse. Thank you for your continued support - stay safe and surf on! 

Send us Fan Mail

For the first time, Surfing NASH takes a deep dive into the prospect of digital therapeutics, their ability to drive outcomes and the critical success factors for proper use and deployment. This is an increasingly apt topic which intermittently surfaces on the podcast but has never featured at the center of conversation. The Surfers are joined by Naim Alkhouri and two new guests with prominent focus in this space: Joe Rubinsztain, CEO and Co-Founder of ChronWell, and Mark Berman, CMO of Better Therapeutics.

In this conversation, Joe and Mark detail their backgrounds and respective roles at two leading digital therapeutics companies. Both Joe and Mark are physicians by training with unique interests which led them down fascinating paths. Joe discloses he is a “computer scientist at heart.” Mark shares that he has always had a passion for nutrition and behavior change. Mark goes on to elaborate on his work today, underscoring a fundamental idea at the foundation of Better Therapeutics. Much of cardiometabolic diseases - including NAFLD - is rooted in behavior. While both primary care and specialty clinics absorb the consequences, neither is adequately equipped to facilitate society-wide behavioral change. Better Therapeutics exists to answer this dilemma by developing forms of what's called Prescription Digital Therapies. Representing a new treatment modality, the use of digital therapeutics under physician supervision can enable digitally-delivered behavioral therapy that is prescribed, reimbursed and accessible to patients in need through the use of a smartphone. Last year, the company announced positive results of a pivotal trial in Type 2 diabetes which demonstrated the use of a Prescription Digital Therapeutic to have clinically meaningful changes in blood sugar control. The company has also expanded its efforts by applying Prescription Digital Therapeutics to combat the swelling burden of NAFLD and NASH. To do so, Mark and his team partnered with two of Naim’s clinics to conduct a feasibility study over the course of three months. Their aim was to recruit participants from a specialty clinic setting who exhibit a range of Fatty Liver disease states and develop data to understand the effects of their therapies on the liver and cardiometabolic condition. Targeting MRI-PDFF as a primary outcome measure, the topline results revealed that the majority of patients were able to demonstrate improved liver health.

...

If you enjoyed this episode and would like to learn more about digital therapeutics, we kindly invite you to leave a review on your preferred listening platform. We also encourage our audience to write us questions to include your on-ground experiences and ideas in the weekly discourse. Thank you for your continued support - stay safe and surf on! 

Send us Fan Mail

For the first time, Surfing NASH takes a deep dive into the prospect of digital therapeutics, their ability to drive outcomes and the critical success factors for proper use and deployment. This is an increasingly apt topic which intermittently surfaces on the podcast but has never featured at the center of conversation. The Surfers are joined by Naim Alkhouri and two new guests with prominent focus in this space: Joe Rubinsztain, CEO and Co-Founder of ChronWell, and Mark Berman, CMO of Better Therapeutics.

Among a plethora of discussion points unpacked, the panelists explore the following major themes:

09:24

Mark is first to elaborate on his work and underscores the big idea at the foundation of Better Therapeutics: much of cardiometabolic diseases - including NAFLD - is rooted in behavior. While both primary care and specialty clinics absorb the consequences, neither is adequately equipped to facilitate society-wide behavioral change. Better Therapeutics exists to answer this dilemma by developing forms of what's called Prescription Digital Therapies. Representing a new treatment modality, the use of digital therapeutics under physician supervision can enable digitally-delivered behavioral therapy that is prescribed, reimbursed and accessible to patients in need through the use of a smartphone.

15:25

Better Therapeutics has recently focused on applying Prescription Digital Therapeutics to combat the swelling burden of NAFLD and NASH. In doing so, their team partnered with two of Naim's clinics to conduct a feasibility study. Naim elaborates on quantifying the analysis of that study. While a 90-day window is restrictive in terms of identifying fibrosis improvement, changes in AST and ALT were examined in addition to analysis of metrics provided by FibroScan. Naim shares ideas around implementing combination therapies which harness digital apps and agents like resmetirom or semaglutide. From here, conversation opens up to impressions and questions from the panelists. Jörn Schattenberg highlights quality of life as a valuable endpoint and Roger Green asks Mark to expand on the premise and deployment of cognitive behavioral therapy.

26:02

Joe details the inception of ChronWell and the company’s mission of assisting providers and insurers to deliver optimal care beyond the medical practice with teams empowered by scalable technology. He envisions a future where “computers are treating simple, delimited diseases in a well designed pathway which is augmenting the ability of a doctor to deliver.” He goes on to discuss the role of insurers in this future and explains the nuances that align ChronWell’s identity as a digital platform.

37:24

The group discusses the benefits behind having an app where patients are in command of their wellness journey. Louise spurs comments around the idea that transparency is enhanced when levels of patient comfort and trust with a process are high. She goes on to describe facets of an app she is developing called MyLife365.me. This is a free lifestyle app that tracks how your daily life choices of food, drink and exercise impacts your liver health.

46:00

Finally, Roger prompts the panelists to share final thoughts around the future of this space. Each offers a unique perspective accounting for different pieces of a collective puzzle: combating Fatty Liver through digital health. If you enjoy the episode or have questions on this subject, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write us directly at [email protected].

Send us Fan Mail

This week's episode From the Vault comes from Season 2, Episode 59.3. Lead author Jeffrey Lazarus and co-author Jörn Schattenberg join Stephen Harrison, Louise Campbell, and Roger Green to discuss the groundbreaking paper “Advancing the Global Health Agenda for NAFLD.” This conversation focuses on what will happen now, why NAFLD is “the canary in the coal mine,” and how we can combine strengths in different parts of the world to make all of our programs more robust.

For Jeff, “what’s next” includes a third, smaller Delphi study as well as a greater focus on Sustainable Development Goals (SDGs) around environment and possible diet. As it continues, Stephen discusses ways to persuade patients (and perhaps societies?) to change habits, practices and beliefs radically to fight this disease. Louise returns to the issue of SDGs to discuss how advocates can leverage the increasing volume of liver cancer patients to represent larger related issues, which leads Jeff to comment on how prevalent and costly liver cancer is today, compared to other cancers. In the end, Stephen recommends a two-item impact strategy: clear messages supported richly through large, high-impact multimedia campaigns.

Send us Fan Mail

In the final conversation on AASLD’s new practice guidance, Roger Green contextualizes a new project he is embarking on with Ken Cusi. Together as co-hosts, they will be debuting a new podcast series from next week titled The NASH Tsunami in Diabetes: Getting Ahead of the Rising Tide. The content featured will largely be targeted toward healthcare professionals who treat diabetic patients, the patients themselves and their caregivers. The NAFLD-diabetes dual prevalence is alarmingly high:

• 15% of diabetic patients may have fibrosis
• In one study, 70% of diabetics had fatty liver and 35% had NASH
• 25% of deaths in people with NAFLD are related to cardiovascular disease
• NAFLD is an independent risk factor for development of diabetes, cardiovascular and chronic kidney diseases

After the group exchanges comments around this exciting news, conversation shifts back toward the practice guidance. Louise Campbell notes approvingly of its array of considerations which include polycystic ovary, menopause, testosterone alteration and the thyroid to name a few. She goes so far as to describe its succinct qualities as “one of the best written guidance documents I think I've ever read.” Jörn Schattenberg adds his appreciation for the inclusion of some high level hepatology concepts around histology and cell ballooning. Roger compares this document to the new generation of hard-cover suitcases that can appear sleek and compact while in fact being stuffed full of important, neatly organized materials. After which, he prods the group in a final question focused on the greatest practical impact of this guidance in the next couple of years. Louise believes it may be the document that strikes the ultimate chord in raising awareness in primary care: “It’s readable, it's digestible and it's implementable.” Jörn reckons the document is a strong step toward embracing multidisciplinary models of care where the NAFLD patient sits at the intersection of many different disciplines. Ken follows with a sizeable wishlist and offers an apt final comment: “If a dream comes true in a lifetime, you didn't dream big enough.” Surf on to discover these thought-provoking final insights.

Send us Fan Mail

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation focuses around the influence the guidance imparts outside of the US.

Jörn Schattenberg shares that an EASL guideline commission has been set forward which will refer to the AASLD guidance in supporting its development. Louise comments on the density of information made available through the guidance, commending its extensive list of references. She expresses concern that NICE will not tap into what’s available here by remaining restricted to data obtained exclusively within the UK. She goes on to advocate for the enormous potential in constructing a guideline that collectively harnesses the “masses of evidence” available in the different guidances emerging throughout the world. When Roger Green asks whether this will be possible, Louise suggests that NICE might be headed in a less insular direction and cites the approval of FibroScan in primary care settings as a recent “leap of faith.” Lastly, she discusses her desire for an investigation into the dynamics of CAP scores to be included in these documents. Jörn agrees and adds that CAP ultimately provides a barometer for metabolic health. At the end of the session, Ken circles these ideas back to the importance behind screening in at-risk populations. 

Send us Fan Mail

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation focuses on the impact this guidance may have on patients: will it make a difference and if so, how?

Ken asserts his position that both patients and providers need to be educated on solutions available today. Measures range from effective diet modifications to bariatric surgery and anti-obesity drugs. Louise Campbell reminds that not all patients interact with physicians and that nurses, dieticians and other allied health professionals experience more numerous contact points in terms of co-morbidity management. She asserts that guidances and guidelines need to make an effective impression on the frontline professionals, caretakers and even the patients themselves. This prompts Ken to share some exciting news with regards to the ADA formally recognizing NASH as a problem associated with diabetes. He reveals that he is chairing a committee which will work to create a consensus statement on this subject through consulting an array of stakeholders. Notably, they are inviting the participation of dieticians, diabetes educators, pharmacy representatives, obesity management leaders, primary care representatives and hepatologists among other groups. Ken expresses his optimism for the momentous energy and convergence of fields in an unprecedented effort to collectively combat Fatty Liver diseases. Jörn adds that such collaboration will drive stronger patient advocacy and better education around what specific questions they should be asking their treaters. 

Send us Fan Mail

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation introduces ideas around how the guidance describes use of biomarkers and NITs to either exclude advanced disease or identify those with a high probability of fibrosis.

Roger Green begins by recalling how the US addressed cholesterol 35 years ago. Reference labs were asked to change what was considered the normal value of cholesterol from two standard deviations above the mean down to a fixed number. This anecdote draws a parallel to the duality facing ALT. He suggests a lower high standard of 30U/L rather than 40U/L could be used, but recognizes that it might not be of benefit to emphasize ALT if patients with normal liver function also have NAFLD. He asks the panelists for their ideas around how we balance these issues to bring ALT into perspective. Jörn Schattenberg notes that typically the upper limit of normal is defined based on the reference population of where the test is evaluated. For example, his hospital in Mainz uses 50U/L on the basis of their reference population. Jörn explains that if this number is changed, an influx of abnormal tests will change the dynamics and economics of patients referred for suspected liver disease. On the other hand, reevaluating cut off points is relevant because patients with normal ALTs are far less likely to be investigated in terms of liver disease. His main takeaway: the guidance demonstrates that the advanced fibrosis disease stage would greatly benefit from the utility of FIB-4. Using this test at a large scale is sufficient and ultimately something to build on. Ken adds that the guidance has aimed to improve the sensitivity of FIB-4 in regards to false positives. He looks forward to the near future of increased precision where the right patients are appropriately referred to clinicians.

Roger notes that as a guidance document in the context of primary care, having three to four statements around ALT might be slightly confusing. He refocuses on the question of whether reference labs have a role in creating clarity around this issue. From a European perspective, Jörn suggests education is needed to drive the question from the physician to the lab. Ken points out that the US electronic medical record system should be able to integrate notifications around cut offs. Louise Campbell asserts the need for AST and ALT to be universally included within blood profiles. At the moment, this is not standard in many countries outside of the US. She harkens back to the potential AI has in the future of automated data analysis, but the essential first step is to ensure tests are able to be computed. In the final comment of this conversation, Ken reiterates the importance of recognizing and driving the message of harnessing what’s readily available today to positively influence the natural history of patient disease.