Surfing the MASH Tsunami

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Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.

Roger begins this conversation by pointing to Jörn’s diversifying role in the NASH community. Specifically, Jörn is prompted to elaborate on his unique perspective in regards to what sort of forward thinking is required in getting “questions asked in a different way.” Jörn first reminds that nomenclature consensus is an ongoing process that has yet to yield a definitive conclusion. More broadly, he goes on to underscore the importance of promoting awareness, education and advocacy around the real impact of Fatty Liver disease on patients and wider communities.

From here the group considers how the nomenclature debate emerged and what cultural and systemic differences may be impacted by a decision going forward. In example, Roger notes that in some countries the word nonalcoholic is useful in that it lifts stigma. The panelists also note the nuances and challenges nomenclature poses to the pediatric population. As the session winds down, Roger states that when dealing with a multi-stakeholder world, you need to start with a truly diffuse, multi-stakeholder solution. Finally, Donna closes with a quote from The Color Purple: “I shouldn't have to fight in my own house. And that's how I feel like as a patient in the NASH community right now.”

Listen to the full feature to engage with these impactful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.

This conversation begins with Jörn’s response to a preceding and powerful statement by Donna around the undervalued input of the patient community. Roger and Donna go on to define in different ways what and why it is that they are concerned about in both the context of the ICER draft report and the nomenclature consensus process. Roger relates this contention to the sociology of in-groups and out-groups. Louise adds her thoughts from the allied health perspective. Her main point is that the role of the nurse is to “listen to both sides” between the physician and the patient while ultimately serving the patients' “well-being, thoughts, feelings and the way they want things to be portrayed.” Not all patients have advocate family members present in hospitals and therefore critical that nurses and other allied health professionals be supported and present to bolster the patient voice. One way to achieve this would be by featuring stronger presence and representation of these groups in panels.  

Listen to the full feature to engage with many more insightful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On!

Send us Fan Mail

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.

Roger prefaces this conversation with a brief recap of Season 4 Episode 19 where a panel of patient advocates (Wayne Eskridge, Michael Betel and Anthony Villiotti) dissected glaring inaccuracies and shortcomings within the ICER draft report. Roger goes on to introduce the rollout of the nomenclature consensus work and candidly shares that it is appearing to be a compromised solution between academics. He reasons it's not clear that it takes into account what other stakeholders need and the practicality behind approving drugs, educating patients and moving the management of the disease forward. From here, Donna describes her frustrations with the weight and value allotted (or lack-thereof) to patient inputs on such important matters. Her statement is powerful and urgent, and describing it in words does not capture the gravity of the moment.

Listen to the full feature to engage with many more insightful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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This week, Donna Cryer (Global Liver Institute) joins Jörn Schattenberg, Louise Campbell and Roger Green for an impassioned and sobering episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. This powerful and at times emotional session expands recent discourse on the ICER draft report to also consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of fighting Fatty Liver through patient-centricity. Among this rich and tremendously honest discussion are the following themes:

00:00 Introduction

07:40 Who is going to be the Larry Kramer of NASH?

17:38 Allied Health for Patient Empowerment

26:59 Generating Data to Demonstrate Patient Needs and Inform Public Health

36:55 Donna’s Call to Action

42:37 Can we absorb enough different perspectives into a common discussion and give them each the weight they deserve?

Listen to the full feature to engage with the many insightful moments. If you enjoy the episode, have questions or interest around patient advocacy, allied health and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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On July 7 2022, Intercept Pharmaceuticals released new results from the continuation of the REGENERATE trial and announced their intent to file a new NDA for obeticholic acid (OCA) in NASH fibrosis. In this conversation From the Vault, Stephen Harrison leads Jörn Schattenberg, Louise Campbell and Roger Green in considering whether the evidence in the new release will be sufficient to get the drug approved.

Stephen starts by noting that we have not heard anything about the results of the REVERSE trial, which evaluated obeticholic acid (OCA) in patients with compensated cirrhosis. As he notes, even if OCA is not approved for cirrhosis, many hepatologists will consider giving this drug to cirrhotic patients, particularly compensated cirrhotics who face a significant worsening of their condition in a fairly short period of time.

Jörn comments on this briefly to agree that the cirrhosis data will create a complete data set, then returns to the pruritus issue. Mostly, his point about cirrhosis is that given the high placebo rate suggests there is “something about how the question is asked.” He finishes this comment by discussing the importance of getting a first drug approved and stating his anticipation of what happens when FDA reviews these data.

Roger goes on to note that he has a unique experience in this group: he has discontinued a drug therapy based on pruritus (in his case, a cancer drug). Having lived through that experience, he expresses skepticism that pruritus that resolves on discontinuation will be a reason for the drug to be rejected. Stephen concurs, and Roger goes on to state that the perceived cardiovascular risk in 2020 made sense as a reason not to approve, but not pruritus. Stephen and Louise concur that we will not know the entire story until we know the lengths to which providers went to keep patients in this study, but both are hopeful (and pretty much expect) that while there may be boundaries on patient types and guidance on treatment, the case for approval appears likely to succeed.

During the second half of this conversation, panelists share their common hope that this data will be sufficient to get OCA approved and discuss what this could mean for the entire Fatty Liver stakeholder community.

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Back in March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). This week, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.

This final conversation focuses on the most important thing each panelist would like ICER to learn before another NASH drug analysis. In our first conversation with Jeff McIntyre, he said that it while it was appreciated that patients have a voice, it's not the same as having a vote. The patient advocate comments in this conversation make it clear exactly how wide the gap between the two is right now. Fortunately, as Veronica miller noted during that preceding episode, ICER reporting has no impact on FDA decisions. However, as we discuss during this conversation, it might have an impact on payers.

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

Stay Safe and Surf On!

Send us Fan Mail

Back in March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). This week, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) explain the why they chose to deliver their specific testimonies.

Mike shares a compelling anecdote around the ongoing challenges which persist in the post-recovery of NAFLD. Specifically, he suggests the document made light of bariatric surgery as a treatment option and failed to consider the extent of preparations and persistence which it requires. Wayne expands on his disappointment with the fact that the document does not consider NAFLD/NASH as a progressive disease. As a numbers guy, Tony explains that he chose to discuss the significant fallacies in the populations and numbers chosen for the economic analysis.

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


Stay Safe and Surf On!

Send us Fan Mail

In March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). In this conversation, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.

Roger begins with the note that if the cost of biopsy is factored into the cost of diagnosing a patient, the cost of diagnosis will be absurd. The group goes on to more extensively explore the role of biopsy in prescribing NASH therapeutics. Wayne shares the idea that lifestyle adjustments take time and can be tremendously difficult to maintain. He asserts that because of this, it would be incredibly valuable if there were a therapeutic option that at least halted progression and in turn provides the time to successfully see through lifestyle interventions. Roger relates this perspective to how we consider trial endpoints. Louise adds comments around the recurring idea that while not every patient is symptomatic, we know this is a progressive disease which doesn’t necessarily fit the sort of spectrum described by ICER. Towards the end of the episode, Mike notes that the public comments session as a whole was rather liver-centric and siloed from more holistic metabolic thinking.

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

Stay Safe and Surf On!

Send us Fan Mail

In March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). In this conversation, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.

Roger begins by asking the group how the word empathy fits into this discussion. Tony shares that he was upset by the majority viewpoint of 15 featured voting members on a number of different issues. For example, 40% of these voting members suggested that a drug approval would have no impact on a caregiver’s life. Tony asserts the importance behind people needing to be aware of the impact of NAFLD/NASH not only on the patient, but also the families and those close to them. Speaking from personal experience, Wayne shares that he was perplexed on the document's position that NAFLD/NASH is not considered to be a progressive disease. This leads Louise and Roger to insert comments around the pricing and economic analysis surrounding the discussion. As the conversation winds down, Mike returns to the conundrum of the voting results. Listen on to hear why his reaction was, “I literally fell out of my chair.”

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


Stay Safe and Surf On!

Send us Fan Mail

In March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). In this conversation, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.

Roger leads by asking the panelists how each came to give commentary and be involved in the process. Both Wayne and Tony disclose that they have previously worked with ICER through different interviews and seamlessly discovered the opportunity to speak on this occasion as a patient advocate. Wayne subsequently invited Mike to deliver a testimony as well. Next, Roger provides a soft introduction which teases the group to consider their feelings about the document and why each chose to comment on the items in which they noted in their testimonies. Similar to the reactions on our first episode on the Draft Report, it immediately becomes clear that the patient advocates also hold reservations regarding a number of different aspects that comprise the document. On one positive note, Tony commends ICER’s willingness to engage with the patient advocate community on a certain level.

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

Stay Safe and Surf On!