Surfing the MASH Tsunami

S6 - E3.3 - Expert: GLI's Jeff McIntyre discusses implications of FDA job cuts on MASH drugs

HEP Dynamics LLC Season 6 Episode 3

This week's Expert is Jeff McIntyre, Vice President, Liver Programs at the Global Liver Institute. His major topic is how recent high-level FDA job cuts might affect MASH drug and diagnostics development. He also shares reactions to FibroSIGHT, HistoIndex's new digital pathology service for clinical practice. 

Highlight: Recent job cuts at the FDA will produce chaos in government and slow response to any emerging crises.

Second Highlight: Patient self-advocacy becomes even more important in this environment.

The conversation takes place on April 1, which lends context to Jeff's opening comment about the rate and nature of change in Washington, DC. He and Roger quickly focus on high-level job cuts at the FDA. 

Jeff believes that the clearest outcome from these changes is that the government will be less able to respond promptly and in a medically appropriate manner to future health crises. Jeff agrees with former FDA Commissioner Rob Califf's comment that the FDA as we know it "is dead," and that we have little idea what the future holds. 

A slower-moving, more chaotic government with a Secretary of HHS who minimizes pharmacotherapies for alternative therapies presents a challenge for all SLD patients. Jeff states that patients need to become more vigilant self-advocates (even more than they are today). He also identifies patient advocacy organizations like GLI as a place patients can go to seek the guidance and support they need from patient advocates. 

Finally, the conversation turns to discuss FibroSIGHT. Jeff describes FibroSIGHT as "exactly where we should be and should not be at the same time," a technology that takes a significant step forward in understanding and patient support, but one that ties us to biopsy as a standard for clinical care. Jeff and Roger agree this issue will play out over the coming years.