S3-E19.4 – NAIL-NIT: “Morphic Resonance” and FDA Test Criteria

S3-E19.4 - NAIL-NIT: "Morphic Resonance" and FDA Test Criteria
The NAIL-NIT leaders explore exactly what makes it so challenging to develop FDA test criteria that match the overall picture of whether a drug is succeeding or not.

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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