S4 E50.11 - Wrapping Up 2023 - An Interview with Global Liver Institute Vice President, Liver Health Programs, Jeff McIntyre
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.