patient advocacy

Today, June 9, was the 5th International NASH Day (#NASHDay). Global Liver Institute (@GlobalLiver), the largest liver patient advocacy organization in the world, and 200 partner organizations held a day of education, awareness and motivation for Fatty Liver stakeholders the world around.

For its wrap-up panel, GLI invited the SurfingNASH co-host team to sit with Jeff McIntyre and review some of the day's major themes as well as major developments since the last International NASH Day. Like a typical SurfingNASH episode, there were equal parts big picture thinking, references to recent events, and laughs. Listen for a fast-paced discussion of big-picture items, most of which are different from the Episode 28 discussion.

On May 27 and 28, Surfing the NASH Tsunami covered the 5th Global NASH Congress, which discussed a wide range of NAFLD topics. In this conversation, Louise Campbell and Rachel Zayas, who attended the conference for Surfing the NASH Tsunami, discuss what they considered the most important and interesting presentations at the Congress.

This fast-moving conversation touches on a range of topics, each of which was a key element of at least one Congress presentation. Specific topics include (1) the importance of patient advocacy and patient presence at events like this, (2) liver science, both in terms of Sven Franque's discussion of how liver fat affects the hepatic vascular bad and Recebba Taub's presentation on the variable relationship between liver fat and liver volume, (3) the idea of transfer RNA as a therapeutic intervention instead of merely a diagnostic, (4) a new VCTE device designed to compete with FibroScan, and (5) an innovative study to evaluate the fatty liver profiles of patients with multiple metabolic diseases currently being treated in primary care practices in Europe. Louise and Rachel focus on what they consider important, challenging or controversial on each subject.

On May 6 and 7, over 100 NAFLD stakeholders convened in Barcelona and on-line for the inaugural Innovations in NAFLD Care 2022 conference (#INCBCN.) Surfing the NASH Tsunami was there, with Jörn Schattenberg serving as event co-founder and Louise Campbell and Roger Green moderating sessions. This week's episode is less a formal recap of the meeting than recollections of key moments and messages from the co-founders and Surfers. Serious comments about meeting design and the importance of stakeholder diversity are interspersed with the conference's lighter moments, in this case referring to Louise being pressed into co-chair services at the last moment.

This conversation starts with the three regular hosts describing the one memory from the weekend that will last the longest for them. Jörn discusses the intensity of the dialogues between stakeholders. Louise focuses on Cyrielle Caussy's presentation on the "fatal triple" of metabolic diseases. Roger identifies two: the passion of the patient advocates and the differences in perspective between traditional top-down, command-and-control specialist medicine as compared to data-driven patient empowerment as depicted by Marcus Ranney's Mito app in development. Given the focus on diverse stakeholders throughout the meeting, the conversation shifts to focus on stakeholders who were NOT well represented: nurses for one, payers and regulators for another. As a final comment, Louise mentions the consistency of a meeting where every presentation, every session was enlightening and satisfying.

On May 6 and 7, over 100 NAFLD stakeholders convened in Barcelona and on-line for the inaugural Innovations in NAFLD Care 2022 conference (#INCBCN.) Surfing the NASH Tsunami was there, with Jörn Schattenberg serving as event co-chair and Louise Campbell and Roger Green moderating sessions. This week's episode is less a formal recap of the meeting than recollections of key moments and messages from the co-founders and Surfers.

This discussion starts with #INCBCN co-founder Jeff Lazarus and Roger Green what Jeff considered the successes and surprises of the conference. Jeff speaks about the "palpable" energy of the attendees, the number of people who attended virtually and engaged through Q & A and the range of issued addressed at the conference as three strong positives. On a more prosaic note, he also mentions how well the technology worked throughout the meeting. Roger Green suggests that much of the energy came from merging three separate streams of activity -- medical specialists, primary care and patient advocates -- into a single conversation that touched on all three groups' issues. He also suggests that having Marcus Ranney and Jeff to share a digital health vision of the future added additional energy and the prospect of what Roger calls "radical patient empowerment." As co-founder Jörn Schattenberg and then Louise Campbell join the conversation, levity ensues as the four discuss the surprise closing statement from Jeff and Jörn and then a more serious tone as the group discusses the benefits that multidisciplinary conversation brought to all the participants.

Founder & CEO of Dreamclinic, Inc. Larisa Goldin, MBA joins us to share how she helps people maneuver and survive the harmful and deadly "Covid" treatment protocols that hospitals are paid to enforce if a patient is declared "Covid positive."

Notes:

• Larisa Goldin's company Dreamclinic https://dreamclinic.com/
• Ivermectin success in India https://newsrescue.com/the-undeniable-ivermectin-miracle-indias-240m-populated-largest-state-uttar-pradesh-horowitz/
• Medicare pays hospitals to list patients as "Covid" & put them on ventilators https://www.usatoday.com/story/news/factcheck/2020/04/24/fact-check-medicare-hospitals-paid-more-covid-19-patients-coronavirus/3000638001/
• Robert Malone MD discusses how hospital administrators are behind the assaults on doctors & science 1:17:28-1:21:36 https://odysee.com/@InformationWarArchive:6/Joe-Rogan-Interviews-Dr-Robert-Malone-M.D.:9e
• NIH study: Remdesivir ineffective for treating Covid https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214279/
• Doctor Reveals Remdesivir Is Real Cause Of COVID-19 Maladies https://principia-scientific.com/doctor-reveals-remdesivir-is-real-cause-of-covid-19-maladies/
• Most Covid 19 patients on ventilators died https://www.webmd.com/lung/news/20200422/most-covid-19-patients-placed-on-ventilators-died-new-york-study-shows#1
• 88% of Covid patients on ventilators died https://www.syracuse.com/coronavirus/2020/04/study-88-of-coronavirus-patients-on-ventilators-died-in-ny.html
• America's Frontline Doctors https://americasfrontlinedoctors.org/
• America's Frontline Nurses https://www.americanfrontlinenurses.com/
• Directory of Doctors Prescribing Outpatient COVID-19 Therapy https://www.exstnc.com/
• Find all our content at https://irida.tv

Factors that make treating NASH and NAFLD a unique challenge for non-Hispanic Black Americans range from Social Determinants of Health (SDOH) to omics suggesting that the disease in Black Americans may be different than in Caucasians or a range of behavioral elements (for example, smoking) that are more closely associated with Black Americans.

This conversation begins with Stephen Harrison noting that a combination of lower incidence of Fatty Liver disease within this population and an historically appropriate trust deficit that non-Hispanic Black Americans feel toward medical trials leads to study samples without enough sample to tell us whether a given diagnostic or course of therapy works better or worse in a non-Hispanic Black American population. As a result, he notes, we do not know how negative health behaviors like smoking or alcohol, genomic patterns and comorbidities affect liver health in this population. Later on, Zaki Sherif notes that in omics work in HCC, he and colleagues identified metabolites that upregulated in Caucasians and down-regulated in Blacks. All this culminated in Donna Cryer's point that this is an historic moment to enrich non-Hispanic Black American populations in these trials so that from the moment we begin using these drugs in the general population, we will know how these drugs work among Blacks instead of simply "assuming" they work as they do with other racial groups, only to lear 5-10 years later than this is wrong.

This wrap-up conversation of our NAIL-NIT episode provides greater detail on NAIL-NIT's research plan. The plan itself includes two elements: a retrospective analysis of data collected to date by drug developers in their own clinical development programs and a six-year prospective study currently estimated to include 1,000 - 1,300 patients, with major adverse liver outcomes (MALOs) anticipated to report in four years and final results in six.
In response to a question, Mazen Noureddin suggested that we might see some significant guidance to drug developers and manufacturers within a year on the topic of screen failure rates. Over time, the retrospective data will also afford the opportunity to test some of the newer composite test measures like FAST and MAST against larger samples of patients. Sen Sundaram expressed a different target for one-year results: guidance from one or more regulatory agencies about how many patients they will want to see in key clinical trial patient cohorts and sub-populations.

In terms of the prospective studies, Louise Campbell asked whether certain segments of patients who had screened out of previous studies would be appropriate for the prospective sample. Stephen Harrison noted that one particular clinical trial, North Sea Therapeutics, included over 100 patients with F3 and NAS of 3 but no balloon hepatocytes. He also noted that by using the Summit Clinical Trial network to recruit a significant share of patients, they would be recruiting a significant share of patients through community trial sites, which can produce patients faster than academic sites. In response to the closing question, NAIL-NIT panelists made a plea for more companies to join this effort.

The conversation looks at how the NAIL-NIT program design improves on the quality of insight provided by the NAS score, both in terms of drug development and treatment of individual patients. Also, note that during this conversation, Mazen Noureddin thanks a relatively large group of individuals and companies supporting this project. 

The first section focuses mostly on what we can and cannot learn from a NAS score, and implications of its shortcomings on the drug development process. After this, Stephen Harrison notes the complex role the liver plays in energy transfer throughout the entire metabolic process. This suggests that the effects of Fatty Liver disease vary among individual patients and, as a result, drug development and patient diagnosis and treatment should provide sufficient insight to optimize each patient's therapy. As the conversation closes, Mazen Noureddin is responding to a question from Louise Campbell about what we will learn about optimal testing strategy. Mazen suggests there is unlikely to be a single "winning" test but, instead, a combination of NITs probably will be necessary to answer all the questions necessary to optimize therapy.

NAIL-NIT is both a response to the challenges of histopathology and an effort to create a different vision of testing liver patients.

This episode starts with Stephen Harrison describing the events that came to demonstrate how challenging current histopathology approaches: a series of drug development failures that reflect shortcomings in methodology rather than in the developmental drugs themselves. Sen Sundaram notes that the difference between the NAIL-NIT approach and that of other consortia is that NAIL-NIT seeks to link NITs directly to outcomes rather than correlating them to histopathology-based measures. Mazen Noureddin discussed the frequency at which patients with obvious NASH and fibrosis fail to screen into studies due to inability to find balloon hepatocytes in the biopsy-derived slides and raises the human ethical implications of excluding these patients. Amy Articolo encourages us to envision a future in which drugs are available to treat patients and make sure we have the best possible testing to diagnose and prescribe the proper therapeutic regimens to patients. From there, the discuss shifts as Stephen Harrison and Sen Sundaram discuss the quality of data existing today that links NITs directly to outcomes. Sen notes that "if we think about the amount of data that we have" for NITs and outcomes, "we probably have more data now than is cited to support histopathology in a current guidance."

NAIL-NIT is a new NAFLD consortium dedicated to exploring the direct relationship between non-invasive testing (NITs) and outcomes in Fatty Liver disease. In this opening conversation, study co-directors Stephen Harrison and Mazen Noureddin are joined by Steering Committee members Amy Articolo, Medical Director for NASH at Novo Nordisk and Senthil Sundaram, CEO of Terns Pharmaceuticals. 

One at a time, the four panelists describe their motivations for forming and becoming a part of this consortium. Mazen Noureddin talks about the group's common goal to produce data that will shape a shift from biopsy-derived drug approval analyses to NITs. Stephen Harrison describes the group's strategy and two main efforts: retrospective analysis of the significant amount of available data that link NITs and outcomes, and a prospective study to be conducted over the next 4-6 years designed to establish correlations and links to outcomes not only for individual tests, for also for combinations of NITs. Sen Sundaram discussed his earlier work with a similar consortium that asked the same kinds of questions about PBC and demonstrated that alkaline phosphatase could provide the analyses necessary for drug approval. Finally, Amy Articolo starts by noting that she has transitioned from a full-time treating OB/GYN to a corporate executive and brought with her a "passion" for "patient-driven, patient-centric care" and several ways that supporting analysis driven entirely by NITs can support support that passion. 

The NAIL-NIT initiative has potential to transform how we evaluate drugs for approval and patients throughout the course of their disease. This is an important episode (and conversation) for anyone with a personal or professional stake in simplifying the NASH/NAFLD drug development process while simultaneously improving the quality of data for regulators and treating physicians alike.

Episode 10 dives into recent NAFLD and NASH Prevalence studies in the US, UK and Germany and explores what this can tell us about who to screen for NAFLD and NASH, when to screen first and how often to screen after that.

This wrap-up conversation wrestles with the question who to screen, when to start and how to reckon with the dual challenge that the early effects of Fatty Liver disease are more about metabolism than liver per se and that there are not enough hepatologists to treat everyone with Fatty Livers. The group's conclusion: we need to test more and earlier, but do not have enough data yet to tell us exactly how to implement this very, very high level statement.

Episode 10 dives into recent NAFLD and NASH Prevalence studies in the US, UK and Germany and explores what this can tell us about who to screen for NAFLD and NASH, when to screen first and how often to screen after that. This conversation focuses on the paper Screening for undiagnosed NAFLD and NASH: A population-based risk factor assessment using Vibration-Controlled Transient Elastography (VCTE), which was published last November in the refereed journal PLOS ONE.

Lead author Wayne Eskridge describes the study and presents key findings. In this conversation, two of the striking points he raises about the study are: (1) that relatively high percentages of study participants, volunteers with no previous history of liver disease, exhibited different levels of liver fat and even disease; and (2) that many of these were patients in their 40s as compared to the 50s and 60s where we more conventionally think about disease. After the group shared some concepts and numbers, participants agreed that the number of adults exhibiting some level of fatty liver with an accompanying metabolic challenge is 3 in 8.

Louise Campbell convenes  liver nursing and nurse educator experts Kathryn Jack, Michele Clayton, Pam O'Donoghue and Patrizia Kunzler to consider where liver nurses and advanced nursing practitioners should fit into treatment and communication paradigms and what support they will need. Stephen Harrison joined to offer a different viewpoint.

Timestamps:
2:42 – Roger introduces session
4:07 – Louise starts discussion
5:37 – Stephen reviews patient case
12:10 – Panel introductions 
22:33 – FIRST QUESTION: health discrimination and quality of care
24:58 – Michele: 2012-3 report stated that patients admitted with alcohol-related liver disease lacked HEP access, received poor treatment. We have made some progress but see similar issues today with COVID-19
27:59 – Patrizia: in Switzerland, liver patients come to care late in disease.  Nurses provide excellent care but are not involved in prevention. Doctors drive the entire decision hierarchy
29:24 – Michele: Similar issue in UK;  where nurses need decision input and greater investment in specialists, particularly in rural areas
31:47 – Kate: Agreed. We lose too many opportunities for nurses to inform and educate
32:40 – Pam: HCC patients on wards present "extremely unwell", in late stages. Nursing “short-staffed.” Not enough time to coach patients. 
33:43 – Pam: I did recordings so I could work with one patient while another consumed recording. We also worked with patients in groups 
36:06 – Stephen: We’re getting closer to our first NASH drug, which will reduce frequency of NASH-HCC if we can treat early enough in disease progression. Also, we need to create a communication model that combines nurses and doctors
37:33 – Stephen: Another target: podiatrists. They  check patients' liver enzymes before Lamisil therapy,  see dysfunction and don’t know what to do. And  which other specialties? Obesity? Cardiology? ENDO? GYN? KEY: two “foundational pillars of education” - doctors and nurses - working collectively to develop and share content
39:38 – Pam: This requires trust between doctors and nurses. Trust takes time
41:24 – Kate: In prisons, once patients are diagnosed, we arrange conversations in person or video. Harder to build rapport without in person. With rapport, everything flows smoothly
43:15 – Kate: We have a system for GPs to refer patients for FibroScan, which is an excellent communication opportunity for nurses
44:58 – Michele: Some UK universities offer liver education, most do not. This is a global challenge
47:07 – Pam:  We should invest some of this billions we spend on HCC systemic therapies in education before and early in  disease progression
48:43 – Michele: Liver "blindsided" countries and planners who focused on renal,  CV and cancer
49:34 – Louise: We spend heavily on expensive late-stage drugs but lack funds to locate and educate at-risk people early in  process or steer them to clinical trials
50:39 – Louise: How can we use the Lancet Commission's  competency documents better?
51:15 – Michele: Others have local competency documents in their own languages
53:25 – Patrizia: Not certain about Swiss association 
54:15 – Stephen: Not aware of a common framework in US
57:48 – FINAL QUESTION: something you would like to see in next 2 years
58:46 – Michele: More global action from/for nurses
58:58 – Kate: Engage other specialties. New UK competency criteria around Fatty Liver
1:00:07 – Kate: More inclusive trial recruitment based on communication in patients' own languages
1:03:14 – Patrizia: Collaboration matters, but support/fund nurses today in research  and publication
1:04:18 – Pam: Encourage British Liver Trust to be more aggressive;  they can be quite effective
1:05:10 – Louise: Bring all the liver disease competencies we have to bear on NAFLD
1:06:53 - Business report

The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this conversation, Stephen Harrison, Louise Campbell and Roger Green join Professors Schattenberg and Lazarus to consider innovative elements for this and future programs and to discuss the outcomes they would like this program (and others like it) to produce.

The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this conversation, Stephen Harrison, Louise Campbell and Roger Green join Professors Schattenberg and Lazarus in discussing structural issues and social determinants of health that are shaping the growing Fatty Liver pandemic and why education is so important to combatting the pandemic.

On this episode of the Mejer Journey Podcast, Nicole DiMonda & Jaime Brambila, Co-Founders of Grace Health and Wellness, take us down the path of what their journey was in uncovering the healing powers of the cannabis plant, how they first got involved at a business-level, and what they're focusing on today to serve the needs of medical patients all over the world.

Joins us for Part 2 of this eye-opening conversation with Dr. Dedeshya Holowenko about menopause.  In this episode we  discuss  the Women's Health Initiative  in the early 2000's and how it derailed the treatment of menopause for a generation of women and their healthcare providers.  Learn  what current research shows about different treatments and what they can do for women and their menopause symptoms.  And even with all the latest research, women still may find it difficult  to access the support they need. Find out what to do if you feel unsupported in your menopause journey. Help IS out there! 

About Dr. Dedeshya Holowenko

Dr. Dedeshya Holowenko is a family physician with a special interest in women's health. She  has a referral based practice where she focuses on women and their unique needs.

Website: www.Iskinpure.com

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Shoni gets vulnerable and candid about her mom’s and her own experience with cancer and why her voice as a Black woman, matters.

You can connect with Shoni on Instagram @brsuga and learn more about For the Breast of Us on their website.

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Thank you for listening!

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My reflections on the conversation:

After our recording, I thought a lot about Shoni’s experience with the receptionist at the oncologist’s office. It’s the kind of experience that is so familiar to those of us who have had to navigate the healthcare system to get care for complex medical conditions. But it is even more stressful when you know that by speaking up, you will be labeled and dismissed with a negative stereotype, like the “angry black woman.” 

These kinds of stressors, even if seemingly minor in isolation, add up over time, and not just in healthcare, but across all kinds of important areas in life, such as education, work, and housing. It’s therefore not surprising that minority groups have less positive health outcomes - living with cancer is completely overwhelming as it is, so some days you just may not have the energy to get over the extra hurdle thrown at you. But that sometimes can make all the difference in your trajectory.

A big shout out to Shoni for bringing to life what we read about in research papers and textbooks. You are not just a number, and we thank you for helping us see you.