Commentary

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

The requisites of government are that there be sufficiency of food, sufficiency of military equipment, and the confidence of the people in their ruler.

Analects by Confucius¹

From ancient festivals to modern holidays, autumn has long been associated with the gathering of the harvest. Friends and families come together around tables laden with delicious food to enjoy the pleasures of peace and plenty. During these celebrations, we must never forget that without the strength of the nation’s military and the service of its veterans, this freedom and abundance would not be possible. Our debt of gratitude to the current and former members of the armed services makes the fact that a substantial minority experiences food insecurity not only a human tragedy, but a travesty of the nation’s promise to support those who wear or have worn the uniform.

The National Defense Authorization Act for Fiscal Year 2020 charged the Secretary of Defense to investigate food insecurity among active-duty service members and their dependents.² The RAND Corporation conducted the assessment and, based on the results of its analysis, made recommendations to reduce hunger among armed forces members and their families.³

The RAND study found that 10% of active-duty military met US Department of Agriculture (USDA) criteria for very low food security; another 15% were classified as having low food security. The USDA defines food insecurity with hunger as “reports of multiple indications of disrupted eating patterns and reduced food intake.” USDA defines low food security as “reports of reduced quality, variety, or desirability of diet. Little or no indication of reduced food intake.”⁴

As someone who grew up on an Army base with the commissary a short trip from military housing, I was unpleasantly surprised that food insecurity was more common among in-service members living on post. I was even more dismayed to read that a variety of factors constrained 14% of active-duty military experiencing food insecurity to seek public assistance to feed themselves and their families. As with so many health care and social services, (eg, mental health care), those wearing the uniform were concerned that participating in a food assistance program would damage their career or stigmatize them. Others did not seek help, perhaps because they believed they were not eligible, and in many cases were correct: they did not qualify for food banks or food stamps due to receiving other benefits. A variety of factors contribute to periods of food insecurity among military families, including remote or rural bases that lack access to grocery stores or jobs for partners or other family members, and low base military pay.⁵

Food insecurity is an even more serious concern among veterans who are frequently older and have more comorbidities, often leading to unemployment and homelessness. Feeding America, the nation’s largest organization of community food banks, estimates that 1 in 9 working-age veterans are food insecure.⁵ US Department of Veterans Affairs (VA) statistics indicate that veterans are 7% more likely to experience food insecurity than other sectors of the population.⁶ The Veterans Health Administration has recognized that food insecurity is directly related to medical problems already common among veterans, including diabetes, obesity, and depression. Women and minority veterans are the most at risk of food insecurity.⁷

Recognizing that many veterans are at risk of food insecurity, the US Department of Defense and VA have taken steps to try and reduce hunger among those who serve. In response to the shocking statistic that food insecurity was found in 27% of Iraq and Afghanistan veterans, the VA and Rockefeller Foundation are partnering on the Food as Medicine initiative to improve veteran nutrition as a means of improving nutrition-related health consequences of food insecurity.⁸

Like many federal practitioners, I was unaware of the food insecurity assistance available to active-duty service members or veterans, or how to help individuals access it. In addition to the resources outlined in the Table, there are many community-based options open to anyone, including veterans and service members. 

I have written columns on many difficult issues in my years as the Editor-in-Chief of Federal Practitioner, but personally this is one of the most distressing editorials I have ever published. That individuals dedicated to defending our rights and protecting our safety should be compelled to go hungry or not know if they have enough money at the end of the month to buy food is manifestly unjust. It is challenging when faced with such a large-scale injustice to think we cannot make a difference, but that resignation or abdication only magnifies this inequity. I have a friend who kept giving back even after they retired from federal service: they volunteered at a community garden and brought produce to the local food bank and helped distribute it. That may seem too much for those still working yet almost anyone can pick up a few items on their weekly shopping trip and donate them to a food drive. 

As we approach Veterans Day, let’s not just express our gratitude to our military and veterans in words but in deeds like feeding the hungry and urging elected representatives to fulfill their commitment to ensure that service members and veterans and their families do not experience food insecurity. Confucian wisdom written in a very distant time and vastly dissimilar context still rings true: there are direct and critical links between food and trust and between hunger and the military.¹

The requisites of government are that there be sufficiency of food, sufficiency of military equipment, and the confidence of the people in their ruler.

Analects by Confucius¹

From ancient festivals to modern holidays, autumn has long been associated with the gathering of the harvest. Friends and families come together around tables laden with delicious food to enjoy the pleasures of peace and plenty. During these celebrations, we must never forget that without the strength of the nation’s military and the service of its veterans, this freedom and abundance would not be possible. Our debt of gratitude to the current and former members of the armed services makes the fact that a substantial minority experiences food insecurity not only a human tragedy, but a travesty of the nation’s promise to support those who wear or have worn the uniform.

The National Defense Authorization Act for Fiscal Year 2020 charged the Secretary of Defense to investigate food insecurity among active-duty service members and their dependents.² The RAND Corporation conducted the assessment and, based on the results of its analysis, made recommendations to reduce hunger among armed forces members and their families.³

The RAND study found that 10% of active-duty military met US Department of Agriculture (USDA) criteria for very low food security; another 15% were classified as having low food security. The USDA defines food insecurity with hunger as “reports of multiple indications of disrupted eating patterns and reduced food intake.” USDA defines low food security as “reports of reduced quality, variety, or desirability of diet. Little or no indication of reduced food intake.”⁴

As someone who grew up on an Army base with the commissary a short trip from military housing, I was unpleasantly surprised that food insecurity was more common among in-service members living on post. I was even more dismayed to read that a variety of factors constrained 14% of active-duty military experiencing food insecurity to seek public assistance to feed themselves and their families. As with so many health care and social services, (eg, mental health care), those wearing the uniform were concerned that participating in a food assistance program would damage their career or stigmatize them. Others did not seek help, perhaps because they believed they were not eligible, and in many cases were correct: they did not qualify for food banks or food stamps due to receiving other benefits. A variety of factors contribute to periods of food insecurity among military families, including remote or rural bases that lack access to grocery stores or jobs for partners or other family members, and low base military pay.⁵

Food insecurity is an even more serious concern among veterans who are frequently older and have more comorbidities, often leading to unemployment and homelessness. Feeding America, the nation’s largest organization of community food banks, estimates that 1 in 9 working-age veterans are food insecure.⁵ US Department of Veterans Affairs (VA) statistics indicate that veterans are 7% more likely to experience food insecurity than other sectors of the population.⁶ The Veterans Health Administration has recognized that food insecurity is directly related to medical problems already common among veterans, including diabetes, obesity, and depression. Women and minority veterans are the most at risk of food insecurity.⁷

Recognizing that many veterans are at risk of food insecurity, the US Department of Defense and VA have taken steps to try and reduce hunger among those who serve. In response to the shocking statistic that food insecurity was found in 27% of Iraq and Afghanistan veterans, the VA and Rockefeller Foundation are partnering on the Food as Medicine initiative to improve veteran nutrition as a means of improving nutrition-related health consequences of food insecurity.⁸

Like many federal practitioners, I was unaware of the food insecurity assistance available to active-duty service members or veterans, or how to help individuals access it. In addition to the resources outlined in the Table, there are many community-based options open to anyone, including veterans and service members. 

I have written columns on many difficult issues in my years as the Editor-in-Chief of Federal Practitioner, but personally this is one of the most distressing editorials I have ever published. That individuals dedicated to defending our rights and protecting our safety should be compelled to go hungry or not know if they have enough money at the end of the month to buy food is manifestly unjust. It is challenging when faced with such a large-scale injustice to think we cannot make a difference, but that resignation or abdication only magnifies this inequity. I have a friend who kept giving back even after they retired from federal service: they volunteered at a community garden and brought produce to the local food bank and helped distribute it. That may seem too much for those still working yet almost anyone can pick up a few items on their weekly shopping trip and donate them to a food drive. 

As we approach Veterans Day, let’s not just express our gratitude to our military and veterans in words but in deeds like feeding the hungry and urging elected representatives to fulfill their commitment to ensure that service members and veterans and their families do not experience food insecurity. Confucian wisdom written in a very distant time and vastly dissimilar context still rings true: there are direct and critical links between food and trust and between hunger and the military.¹

The requisites of government are that there be sufficiency of food, sufficiency of military equipment, and the confidence of the people in their ruler.

Analects by Confucius¹

From ancient festivals to modern holidays, autumn has long been associated with the gathering of the harvest. Friends and families come together around tables laden with delicious food to enjoy the pleasures of peace and plenty. During these celebrations, we must never forget that without the strength of the nation’s military and the service of its veterans, this freedom and abundance would not be possible. Our debt of gratitude to the current and former members of the armed services makes the fact that a substantial minority experiences food insecurity not only a human tragedy, but a travesty of the nation’s promise to support those who wear or have worn the uniform.

The National Defense Authorization Act for Fiscal Year 2020 charged the Secretary of Defense to investigate food insecurity among active-duty service members and their dependents.² The RAND Corporation conducted the assessment and, based on the results of its analysis, made recommendations to reduce hunger among armed forces members and their families.³

The RAND study found that 10% of active-duty military met US Department of Agriculture (USDA) criteria for very low food security; another 15% were classified as having low food security. The USDA defines food insecurity with hunger as “reports of multiple indications of disrupted eating patterns and reduced food intake.” USDA defines low food security as “reports of reduced quality, variety, or desirability of diet. Little or no indication of reduced food intake.”⁴

As someone who grew up on an Army base with the commissary a short trip from military housing, I was unpleasantly surprised that food insecurity was more common among in-service members living on post. I was even more dismayed to read that a variety of factors constrained 14% of active-duty military experiencing food insecurity to seek public assistance to feed themselves and their families. As with so many health care and social services, (eg, mental health care), those wearing the uniform were concerned that participating in a food assistance program would damage their career or stigmatize them. Others did not seek help, perhaps because they believed they were not eligible, and in many cases were correct: they did not qualify for food banks or food stamps due to receiving other benefits. A variety of factors contribute to periods of food insecurity among military families, including remote or rural bases that lack access to grocery stores or jobs for partners or other family members, and low base military pay.⁵

Food insecurity is an even more serious concern among veterans who are frequently older and have more comorbidities, often leading to unemployment and homelessness. Feeding America, the nation’s largest organization of community food banks, estimates that 1 in 9 working-age veterans are food insecure.⁵ US Department of Veterans Affairs (VA) statistics indicate that veterans are 7% more likely to experience food insecurity than other sectors of the population.⁶ The Veterans Health Administration has recognized that food insecurity is directly related to medical problems already common among veterans, including diabetes, obesity, and depression. Women and minority veterans are the most at risk of food insecurity.⁷

Recognizing that many veterans are at risk of food insecurity, the US Department of Defense and VA have taken steps to try and reduce hunger among those who serve. In response to the shocking statistic that food insecurity was found in 27% of Iraq and Afghanistan veterans, the VA and Rockefeller Foundation are partnering on the Food as Medicine initiative to improve veteran nutrition as a means of improving nutrition-related health consequences of food insecurity.⁸

Like many federal practitioners, I was unaware of the food insecurity assistance available to active-duty service members or veterans, or how to help individuals access it. In addition to the resources outlined in the Table, there are many community-based options open to anyone, including veterans and service members. 

I have written columns on many difficult issues in my years as the Editor-in-Chief of Federal Practitioner, but personally this is one of the most distressing editorials I have ever published. That individuals dedicated to defending our rights and protecting our safety should be compelled to go hungry or not know if they have enough money at the end of the month to buy food is manifestly unjust. It is challenging when faced with such a large-scale injustice to think we cannot make a difference, but that resignation or abdication only magnifies this inequity. I have a friend who kept giving back even after they retired from federal service: they volunteered at a community garden and brought produce to the local food bank and helped distribute it. That may seem too much for those still working yet almost anyone can pick up a few items on their weekly shopping trip and donate them to a food drive. 

As we approach Veterans Day, let’s not just express our gratitude to our military and veterans in words but in deeds like feeding the hungry and urging elected representatives to fulfill their commitment to ensure that service members and veterans and their families do not experience food insecurity. Confucian wisdom written in a very distant time and vastly dissimilar context still rings true: there are direct and critical links between food and trust and between hunger and the military.¹

An October 1 article in GI & Hepatology News cautioned physicians against partnering with private equity firms, warning that they target “quick profits and quick exits, which can be inconsistent with quality long-term patient care.”

But several recent studies – and my own experience – show that affiliating with a private equity-backed management services organization can empower physician practices to deliver high-quality care at lower cost than other practice affiliation models.

A 2024 study conducted by Avalere Health found that per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated practice model to a PE-affiliated model declined by $963 in the 12 months following the transition. By contrast, per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated model to a hospital-affiliated one increased more than $1,300.

A 2025 peer-reviewed study published in Journal of Market Access & Health Policy found that physicians affiliated with private equity were far more likely to perform common high-volume procedures in the lowest-cost site of care – an ambulatory surgery center or medical office – than in higher-cost hospital outpatient departments. Physicians affiliated with hospitals were far more likely to perform procedures in HOPDs.

Partnering with a private equity-backed management services organization has enabled my practice to afford advanced technologies we never could have deployed on our own. Those technologies have helped improve our polyp detection rates, reduce the incidence of colon cancer, and more efficiently care for patients with ulcerative colitis. We also now provide patients seamless access to digital platforms that help them better manage chronic conditions.

Independent medical practice is under duress. Partnering with a private equity-backed management services organization is one of the most effective ways for a physician practice to retain its independence – and continue offering patients affordable, high-quality care.

George Dickstein, MD, AGAF, is senior vice president of clinical affairs, Massachusetts, for Gastro Health, and chairperson of Gastro Health’s Physician Leadership Council. He is based in Framingham, Mass. GI & Hepatology News encourages readers to submit letters to the editor to debate topics raised in the newspaper.

An October 1 article in GI & Hepatology News cautioned physicians against partnering with private equity firms, warning that they target “quick profits and quick exits, which can be inconsistent with quality long-term patient care.”

But several recent studies – and my own experience – show that affiliating with a private equity-backed management services organization can empower physician practices to deliver high-quality care at lower cost than other practice affiliation models.

A 2024 study conducted by Avalere Health found that per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated practice model to a PE-affiliated model declined by $963 in the 12 months following the transition. By contrast, per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated model to a hospital-affiliated one increased more than $1,300.

A 2025 peer-reviewed study published in Journal of Market Access & Health Policy found that physicians affiliated with private equity were far more likely to perform common high-volume procedures in the lowest-cost site of care – an ambulatory surgery center or medical office – than in higher-cost hospital outpatient departments. Physicians affiliated with hospitals were far more likely to perform procedures in HOPDs.

Partnering with a private equity-backed management services organization has enabled my practice to afford advanced technologies we never could have deployed on our own. Those technologies have helped improve our polyp detection rates, reduce the incidence of colon cancer, and more efficiently care for patients with ulcerative colitis. We also now provide patients seamless access to digital platforms that help them better manage chronic conditions.

Independent medical practice is under duress. Partnering with a private equity-backed management services organization is one of the most effective ways for a physician practice to retain its independence – and continue offering patients affordable, high-quality care.

George Dickstein, MD, AGAF, is senior vice president of clinical affairs, Massachusetts, for Gastro Health, and chairperson of Gastro Health’s Physician Leadership Council. He is based in Framingham, Mass. GI & Hepatology News encourages readers to submit letters to the editor to debate topics raised in the newspaper.

An October 1 article in GI & Hepatology News cautioned physicians against partnering with private equity firms, warning that they target “quick profits and quick exits, which can be inconsistent with quality long-term patient care.”

But several recent studies – and my own experience – show that affiliating with a private equity-backed management services organization can empower physician practices to deliver high-quality care at lower cost than other practice affiliation models.

A 2024 study conducted by Avalere Health found that per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated practice model to a PE-affiliated model declined by $963 in the 12 months following the transition. By contrast, per-beneficiary Medicare expenditures for physicians who shifted from an unaffiliated model to a hospital-affiliated one increased more than $1,300.

A 2025 peer-reviewed study published in Journal of Market Access & Health Policy found that physicians affiliated with private equity were far more likely to perform common high-volume procedures in the lowest-cost site of care – an ambulatory surgery center or medical office – than in higher-cost hospital outpatient departments. Physicians affiliated with hospitals were far more likely to perform procedures in HOPDs.

Partnering with a private equity-backed management services organization has enabled my practice to afford advanced technologies we never could have deployed on our own. Those technologies have helped improve our polyp detection rates, reduce the incidence of colon cancer, and more efficiently care for patients with ulcerative colitis. We also now provide patients seamless access to digital platforms that help them better manage chronic conditions.

Independent medical practice is under duress. Partnering with a private equity-backed management services organization is one of the most effective ways for a physician practice to retain its independence – and continue offering patients affordable, high-quality care.

George Dickstein, MD, AGAF, is senior vice president of clinical affairs, Massachusetts, for Gastro Health, and chairperson of Gastro Health’s Physician Leadership Council. He is based in Framingham, Mass. GI & Hepatology News encourages readers to submit letters to the editor to debate topics raised in the newspaper.

What are the American Academy of Dermatology’s (AAD’s) top advocacy priorities related to Medicare physician reimbursement?

Dr. Taylor: Medicare physician payment has failed to keep up with inflation, threatening the viability of medical practices. The AAD urges Congress to stabilize the Medicare payment system to ensure continued patient access to essential health care by cosponsoring the Medicare Patient Access and Practice Stabilization Act of 2025, which reverses the 2.83% cut and provides a positive inflationary adjustment for physician practices for 2025. In July 2025, Congress passed the One Big Beautiful Bill Act, which provides for a 1-year 2.5% increase to Medicare physician payment in 2026 to account for sustained cuts as Congress continues to work toward long-term payment reform. This short-term remedy is only applicable to 2026—a fix for 2025 as well as long-term reform still are needed. The AAD recently formed an ad-hoc task force on sustaining physician practices for senior citizen care that will continue to press for solutions to the Medicare payment crisis.

What is the AAD’s stance on transitioning from traditional fee-for-service to value-based care models in dermatology under Medicare?

Dr. Taylor: Current value-based programs are extremely burdensome, have not demonstrated improved patient care, and are not clinically relevant to physicians or patients. The AAD has serious concerns about the viability and effectiveness of the Quality Payment Program (QPP), especially the Merit-Based Incentive Payment System (MIPS). Numerous studies have highlighted persistent challenges associated with MIPS, including practices serving high-risk patients and those that are small or in rural areas. For instance, researchers examined whether MIPS disproportionately penalized surgeons who care for these patients and found a connection between caring for these patients, lower MIPS scores, and a higher likelihood of facing negative payment adjustments.

Additionally, the US Government Accountability Office was tasked with reviewing several aspects concerning small and rural practices in relation to Medicare payment incentive programs, including MIPS. Findings indicated that physician practices with 15 or fewer providers, whether located in rural or nonrural areas, had a higher likelihood of receiving negative payment adjustments in Medicare incentive programs compared to larger practices. To maximize participation and facilitate the best possible outcomes for dermatologists within the MIPS program, the AAD maintains that we must continue to develop and advocate that the Centers for Medicare and Medicaid Services approve dermatology-specific measures for MIPS reporting.

Does the AAD have plans to develop or expand dermatology-specific quality measures that are more clinically relevant and less administratively taxing?

Dr. Taylor: The AAD is committed to ensuring that dermatologists can be successful in the QPP and its MIPS Value Pathways and Advanced Alternative Payment Model programs. These payment pathways for QPP-eligible participants allow physicians to increase their future Medicare reimbursements but also penalize those who do not meet performance objectives. The AAD is constantly reviewing and proposing new dermatology-specific quality measures to the Centers for Medicare and Medicaid Services based on member feedback to reduce administrative burdens of MIPS reporting. All of our quality measures are developed by dermatologists for dermatologists.

How is the AAD supporting practices dealing with insurer-mandated switch policies that disrupt continuity of care and increase documentation burden?

Dr. Taylor: The AAD works with private payers to alleviate administrative burdens for dermatologists, maintain appropriate reimbursement for services provided, and ensure patients can access covered quality care by building and maintaining relationships with public and private payers. This critical collaboration addresses immediate needs affecting our members’ ability to deliver care, such as when policy changes affect claims and formulary coverage or payment. Our coordinated strategy ensures payer policies align with everyday practice for dermatologists so they can focus on treating patients. The AAD has resources and tools to guide dermatology practices in appropriate documentation and coding.

What initiatives is the AAD pursuing to specifically support independent or small dermatology practices in coping with administrative overload?

Dr. Taylor: The AAD is continuously advocating for our small and independent dermatology practices. In every comment letter we submit on proposed medical practice reporting regulation, we demand small practice exemptions. Moreover, the AAD has resources and practical tools for all types of practices to cope with administrative burdens, including MIPS reporting requirements. These resources and tools were created by dermatologists for dermatologists to take the guesswork out of administrative compliance. DataDerm is the AAD’s clinical data registry used for MIPS reporting. Since its launch in 2016, DataDerm has become dermatology’s largest clinical data registry, capturing information on more than 16 million unique patients and 69 million encounters. It supports the advancement of skin disease diagnosis and treatment, informs clinical practice, streamlines MIPS reporting, and drives clinically relevant research using real-world data.

What are the biggest contributors to physician burnout right now? What resources does AAD offer to support dermatologists in managing burnout?

Dr. Taylor: The biggest contributors to burnout that dermatologists are facing are demanding workloads, administrative burdens, and loss of autonomy. Dermatologists welcome medical challenges, but they face growing administrative and regulatory burdens that take time away from patient care and contribute to burnout. Taking a wellness-centered approach can help, which is why the AAD includes both practical tools to reduce burdens and strategies to sustain your practice in its online resources. The burnout and wellness section of the AAD website can help with administrative burdens, building a supportive work culture, recognizing drivers of burnout, reconnecting with your purpose, and more.

How is the AAD working to ensure that the expanding scope of practice does not compromise patient safety, particularly when it comes to diagnosis and treatment of complex skin cancers or prescribing systemic medications?

Dr. Taylor: The AAD advocates to ensure that each member of the care team is practicing at a level consistent with their training and education and opposes scope-of-practice expansions for physician assistants, nurse practitioners, and other nonphysician clinicians that threaten patient safety by allowing them to practice independently and advertise as skin experts. Each state has its own scope-of-practice laws governing what nonphysicians can do, whether supervision is required, and how they can represent their training, both in advertising and in a medical practice. The AAD supports appropriate safeguards to ensure patient safety and a focus on the highest-quality appropriate care as the nonphysician workforce expands. The AAD encourages patients to report adverse outcomes to the appropriate state licensing boards.

Is the AAD developing or recommending best practices for dermatologists who supervise NPs or PAs, especially in large practices or retail clinics where oversight can be inconsistent?

Dr. Taylor: The AAD firmly believes that the optimal quality of medical care is delivered when a qualified and licensed physician provides direct on-site supervision to all qualified nonphysician personnel. A medical director of a medical spa facility should be a physician licensed in the state where the facility is located and also should be clearly identified by state licensure and any state-recognized board certification as well as by medical specialty, training, and education. The individual also should be identified as the medical director in all marketing materials and on websites and social media accounts related to the medical spa facility. The AAD would like to see policies that would provide increased transparency in state licensure and specialty board certification including requiring disclosure that a physician is certified or eligible for certification by a private or public board, parent association, or multidisciplinary board or association; requiring disclosure of the certifying board or association with one’s field of study or specialty; requiring display of visible identification—including one’s state licensure, professional degree, field of study, and the use of clarifying titles—in facilities, in marketing materials, and on websites and social media; and requiring all personnel in private medical practices, hospitals, clinics, or other settings employing physicians and/or other personnel that offer medical, surgical, or aesthetic procedures to wear a photo identification name tag during all patient encounters.

What are the American Academy of Dermatology’s (AAD’s) top advocacy priorities related to Medicare physician reimbursement?

Dr. Taylor: Medicare physician payment has failed to keep up with inflation, threatening the viability of medical practices. The AAD urges Congress to stabilize the Medicare payment system to ensure continued patient access to essential health care by cosponsoring the Medicare Patient Access and Practice Stabilization Act of 2025, which reverses the 2.83% cut and provides a positive inflationary adjustment for physician practices for 2025. In July 2025, Congress passed the One Big Beautiful Bill Act, which provides for a 1-year 2.5% increase to Medicare physician payment in 2026 to account for sustained cuts as Congress continues to work toward long-term payment reform. This short-term remedy is only applicable to 2026—a fix for 2025 as well as long-term reform still are needed. The AAD recently formed an ad-hoc task force on sustaining physician practices for senior citizen care that will continue to press for solutions to the Medicare payment crisis.

What is the AAD’s stance on transitioning from traditional fee-for-service to value-based care models in dermatology under Medicare?

Dr. Taylor: Current value-based programs are extremely burdensome, have not demonstrated improved patient care, and are not clinically relevant to physicians or patients. The AAD has serious concerns about the viability and effectiveness of the Quality Payment Program (QPP), especially the Merit-Based Incentive Payment System (MIPS). Numerous studies have highlighted persistent challenges associated with MIPS, including practices serving high-risk patients and those that are small or in rural areas. For instance, researchers examined whether MIPS disproportionately penalized surgeons who care for these patients and found a connection between caring for these patients, lower MIPS scores, and a higher likelihood of facing negative payment adjustments.

Additionally, the US Government Accountability Office was tasked with reviewing several aspects concerning small and rural practices in relation to Medicare payment incentive programs, including MIPS. Findings indicated that physician practices with 15 or fewer providers, whether located in rural or nonrural areas, had a higher likelihood of receiving negative payment adjustments in Medicare incentive programs compared to larger practices. To maximize participation and facilitate the best possible outcomes for dermatologists within the MIPS program, the AAD maintains that we must continue to develop and advocate that the Centers for Medicare and Medicaid Services approve dermatology-specific measures for MIPS reporting.

Does the AAD have plans to develop or expand dermatology-specific quality measures that are more clinically relevant and less administratively taxing?

Dr. Taylor: The AAD is committed to ensuring that dermatologists can be successful in the QPP and its MIPS Value Pathways and Advanced Alternative Payment Model programs. These payment pathways for QPP-eligible participants allow physicians to increase their future Medicare reimbursements but also penalize those who do not meet performance objectives. The AAD is constantly reviewing and proposing new dermatology-specific quality measures to the Centers for Medicare and Medicaid Services based on member feedback to reduce administrative burdens of MIPS reporting. All of our quality measures are developed by dermatologists for dermatologists.

How is the AAD supporting practices dealing with insurer-mandated switch policies that disrupt continuity of care and increase documentation burden?

Dr. Taylor: The AAD works with private payers to alleviate administrative burdens for dermatologists, maintain appropriate reimbursement for services provided, and ensure patients can access covered quality care by building and maintaining relationships with public and private payers. This critical collaboration addresses immediate needs affecting our members’ ability to deliver care, such as when policy changes affect claims and formulary coverage or payment. Our coordinated strategy ensures payer policies align with everyday practice for dermatologists so they can focus on treating patients. The AAD has resources and tools to guide dermatology practices in appropriate documentation and coding.

What initiatives is the AAD pursuing to specifically support independent or small dermatology practices in coping with administrative overload?

Dr. Taylor: The AAD is continuously advocating for our small and independent dermatology practices. In every comment letter we submit on proposed medical practice reporting regulation, we demand small practice exemptions. Moreover, the AAD has resources and practical tools for all types of practices to cope with administrative burdens, including MIPS reporting requirements. These resources and tools were created by dermatologists for dermatologists to take the guesswork out of administrative compliance. DataDerm is the AAD’s clinical data registry used for MIPS reporting. Since its launch in 2016, DataDerm has become dermatology’s largest clinical data registry, capturing information on more than 16 million unique patients and 69 million encounters. It supports the advancement of skin disease diagnosis and treatment, informs clinical practice, streamlines MIPS reporting, and drives clinically relevant research using real-world data.

What are the biggest contributors to physician burnout right now? What resources does AAD offer to support dermatologists in managing burnout?

Dr. Taylor: The biggest contributors to burnout that dermatologists are facing are demanding workloads, administrative burdens, and loss of autonomy. Dermatologists welcome medical challenges, but they face growing administrative and regulatory burdens that take time away from patient care and contribute to burnout. Taking a wellness-centered approach can help, which is why the AAD includes both practical tools to reduce burdens and strategies to sustain your practice in its online resources. The burnout and wellness section of the AAD website can help with administrative burdens, building a supportive work culture, recognizing drivers of burnout, reconnecting with your purpose, and more.

How is the AAD working to ensure that the expanding scope of practice does not compromise patient safety, particularly when it comes to diagnosis and treatment of complex skin cancers or prescribing systemic medications?

Dr. Taylor: The AAD advocates to ensure that each member of the care team is practicing at a level consistent with their training and education and opposes scope-of-practice expansions for physician assistants, nurse practitioners, and other nonphysician clinicians that threaten patient safety by allowing them to practice independently and advertise as skin experts. Each state has its own scope-of-practice laws governing what nonphysicians can do, whether supervision is required, and how they can represent their training, both in advertising and in a medical practice. The AAD supports appropriate safeguards to ensure patient safety and a focus on the highest-quality appropriate care as the nonphysician workforce expands. The AAD encourages patients to report adverse outcomes to the appropriate state licensing boards.

Is the AAD developing or recommending best practices for dermatologists who supervise NPs or PAs, especially in large practices or retail clinics where oversight can be inconsistent?

Dr. Taylor: The AAD firmly believes that the optimal quality of medical care is delivered when a qualified and licensed physician provides direct on-site supervision to all qualified nonphysician personnel. A medical director of a medical spa facility should be a physician licensed in the state where the facility is located and also should be clearly identified by state licensure and any state-recognized board certification as well as by medical specialty, training, and education. The individual also should be identified as the medical director in all marketing materials and on websites and social media accounts related to the medical spa facility. The AAD would like to see policies that would provide increased transparency in state licensure and specialty board certification including requiring disclosure that a physician is certified or eligible for certification by a private or public board, parent association, or multidisciplinary board or association; requiring disclosure of the certifying board or association with one’s field of study or specialty; requiring display of visible identification—including one’s state licensure, professional degree, field of study, and the use of clarifying titles—in facilities, in marketing materials, and on websites and social media; and requiring all personnel in private medical practices, hospitals, clinics, or other settings employing physicians and/or other personnel that offer medical, surgical, or aesthetic procedures to wear a photo identification name tag during all patient encounters.

What are the American Academy of Dermatology’s (AAD’s) top advocacy priorities related to Medicare physician reimbursement?

Dr. Taylor: Medicare physician payment has failed to keep up with inflation, threatening the viability of medical practices. The AAD urges Congress to stabilize the Medicare payment system to ensure continued patient access to essential health care by cosponsoring the Medicare Patient Access and Practice Stabilization Act of 2025, which reverses the 2.83% cut and provides a positive inflationary adjustment for physician practices for 2025. In July 2025, Congress passed the One Big Beautiful Bill Act, which provides for a 1-year 2.5% increase to Medicare physician payment in 2026 to account for sustained cuts as Congress continues to work toward long-term payment reform. This short-term remedy is only applicable to 2026—a fix for 2025 as well as long-term reform still are needed. The AAD recently formed an ad-hoc task force on sustaining physician practices for senior citizen care that will continue to press for solutions to the Medicare payment crisis.

What is the AAD’s stance on transitioning from traditional fee-for-service to value-based care models in dermatology under Medicare?

Dr. Taylor: Current value-based programs are extremely burdensome, have not demonstrated improved patient care, and are not clinically relevant to physicians or patients. The AAD has serious concerns about the viability and effectiveness of the Quality Payment Program (QPP), especially the Merit-Based Incentive Payment System (MIPS). Numerous studies have highlighted persistent challenges associated with MIPS, including practices serving high-risk patients and those that are small or in rural areas. For instance, researchers examined whether MIPS disproportionately penalized surgeons who care for these patients and found a connection between caring for these patients, lower MIPS scores, and a higher likelihood of facing negative payment adjustments.

Additionally, the US Government Accountability Office was tasked with reviewing several aspects concerning small and rural practices in relation to Medicare payment incentive programs, including MIPS. Findings indicated that physician practices with 15 or fewer providers, whether located in rural or nonrural areas, had a higher likelihood of receiving negative payment adjustments in Medicare incentive programs compared to larger practices. To maximize participation and facilitate the best possible outcomes for dermatologists within the MIPS program, the AAD maintains that we must continue to develop and advocate that the Centers for Medicare and Medicaid Services approve dermatology-specific measures for MIPS reporting.

Does the AAD have plans to develop or expand dermatology-specific quality measures that are more clinically relevant and less administratively taxing?

Dr. Taylor: The AAD is committed to ensuring that dermatologists can be successful in the QPP and its MIPS Value Pathways and Advanced Alternative Payment Model programs. These payment pathways for QPP-eligible participants allow physicians to increase their future Medicare reimbursements but also penalize those who do not meet performance objectives. The AAD is constantly reviewing and proposing new dermatology-specific quality measures to the Centers for Medicare and Medicaid Services based on member feedback to reduce administrative burdens of MIPS reporting. All of our quality measures are developed by dermatologists for dermatologists.

How is the AAD supporting practices dealing with insurer-mandated switch policies that disrupt continuity of care and increase documentation burden?

Dr. Taylor: The AAD works with private payers to alleviate administrative burdens for dermatologists, maintain appropriate reimbursement for services provided, and ensure patients can access covered quality care by building and maintaining relationships with public and private payers. This critical collaboration addresses immediate needs affecting our members’ ability to deliver care, such as when policy changes affect claims and formulary coverage or payment. Our coordinated strategy ensures payer policies align with everyday practice for dermatologists so they can focus on treating patients. The AAD has resources and tools to guide dermatology practices in appropriate documentation and coding.

What initiatives is the AAD pursuing to specifically support independent or small dermatology practices in coping with administrative overload?

Dr. Taylor: The AAD is continuously advocating for our small and independent dermatology practices. In every comment letter we submit on proposed medical practice reporting regulation, we demand small practice exemptions. Moreover, the AAD has resources and practical tools for all types of practices to cope with administrative burdens, including MIPS reporting requirements. These resources and tools were created by dermatologists for dermatologists to take the guesswork out of administrative compliance. DataDerm is the AAD’s clinical data registry used for MIPS reporting. Since its launch in 2016, DataDerm has become dermatology’s largest clinical data registry, capturing information on more than 16 million unique patients and 69 million encounters. It supports the advancement of skin disease diagnosis and treatment, informs clinical practice, streamlines MIPS reporting, and drives clinically relevant research using real-world data.

What are the biggest contributors to physician burnout right now? What resources does AAD offer to support dermatologists in managing burnout?

Dr. Taylor: The biggest contributors to burnout that dermatologists are facing are demanding workloads, administrative burdens, and loss of autonomy. Dermatologists welcome medical challenges, but they face growing administrative and regulatory burdens that take time away from patient care and contribute to burnout. Taking a wellness-centered approach can help, which is why the AAD includes both practical tools to reduce burdens and strategies to sustain your practice in its online resources. The burnout and wellness section of the AAD website can help with administrative burdens, building a supportive work culture, recognizing drivers of burnout, reconnecting with your purpose, and more.

How is the AAD working to ensure that the expanding scope of practice does not compromise patient safety, particularly when it comes to diagnosis and treatment of complex skin cancers or prescribing systemic medications?

Dr. Taylor: The AAD advocates to ensure that each member of the care team is practicing at a level consistent with their training and education and opposes scope-of-practice expansions for physician assistants, nurse practitioners, and other nonphysician clinicians that threaten patient safety by allowing them to practice independently and advertise as skin experts. Each state has its own scope-of-practice laws governing what nonphysicians can do, whether supervision is required, and how they can represent their training, both in advertising and in a medical practice. The AAD supports appropriate safeguards to ensure patient safety and a focus on the highest-quality appropriate care as the nonphysician workforce expands. The AAD encourages patients to report adverse outcomes to the appropriate state licensing boards.

Is the AAD developing or recommending best practices for dermatologists who supervise NPs or PAs, especially in large practices or retail clinics where oversight can be inconsistent?

Dr. Taylor: The AAD firmly believes that the optimal quality of medical care is delivered when a qualified and licensed physician provides direct on-site supervision to all qualified nonphysician personnel. A medical director of a medical spa facility should be a physician licensed in the state where the facility is located and also should be clearly identified by state licensure and any state-recognized board certification as well as by medical specialty, training, and education. The individual also should be identified as the medical director in all marketing materials and on websites and social media accounts related to the medical spa facility. The AAD would like to see policies that would provide increased transparency in state licensure and specialty board certification including requiring disclosure that a physician is certified or eligible for certification by a private or public board, parent association, or multidisciplinary board or association; requiring disclosure of the certifying board or association with one’s field of study or specialty; requiring display of visible identification—including one’s state licensure, professional degree, field of study, and the use of clarifying titles—in facilities, in marketing materials, and on websites and social media; and requiring all personnel in private medical practices, hospitals, clinics, or other settings employing physicians and/or other personnel that offer medical, surgical, or aesthetic procedures to wear a photo identification name tag during all patient encounters.

The impact of pseudofolliculitis barbae (PFB) on military service members and other uniformed professionals has been a topic of recent interest due to the announcement of the US Army’s new shaving rule in July 2025.¹ The policy prohibits permanent shaving waivers, requires medical re-evaluation of shaving profiles within 90 days, and allows for administrative separation if a service member accumulates shaving exceptions totaling more than 12 months over a 24-month period.² A common skin condition triggered or worsened by shaving, PFB causes painful bumps, pustules, and hyperpigmentation most often in the beard and cheek areas and negatively impacts quality of life. It disproportionately affects 45% to 83% of men in the United States, particularly those of African, Hispanic, or Middle Eastern descent.^3,4 Genetic factors, particularly tightly coiled or coarse curly hair, can predispose individuals to PFB. The most successful treatment for PFB is to stop shaving, but this conflicts with military shaving standards and interferes with the use of protective equipment (eg, masks). Herein, we highlight the adverse impact of PFB on military career progression and provide context for clinicians who treat patients with PFB, especially as policies recently have shifted to allow nonmilitary clinicians to evaluate PFB in service members.⁵

Shaving Waivers and Advancement

Pseudofolliculitis barbae disproportionately prolongs the time to advancement of many service members, and those with PFB also are overburdened by policy changes related to shaving.⁶ In the US military, nearly 18% of the active-duty force is Black,⁷ a population that is more susceptible to PFB. Military personnel may request PFB-related accommodations, including medical shaving waivers that vary by branch. Through a formal documentation process, waivers allow service members to maintain facial hair up to one-quarter inch in length.⁵ Previously, waivers could be temporary (eg, up to 90 days) or permanent as subjectively determined based on clinician-documented disease severity. Almost 65% of US Air Force medical shaving waivers are held by Black men, and PFB is one of the most common reasons.⁶ Notably, the US Navy discontinued permanent shaving waivers in October 2019.⁸ A US Marine Corps policy issued in March 2025 now allows administrative separation of service members with PFB if symptoms do not improve after a 1-year medical shaving waiver due to “incompatibility with service.”⁹ This change reversed a 2022 policy that protected Marines from separation based on PFB.¹⁰ A Marine Corps spokesperson stated that this change aims to clarify how medical conditions can impact uniform compliance and standardize medical condition management while prioritizing compliance and duty readiness.¹

Even in the absence of policy changes, obtaining a medical shaving waiver for PFB can be challenging. Service members may have little to no access to military dermatologists who specialize in management of PFB and experience long wait times for civilian network deferment. Service members seen in civilian clinics may have restricted treatment options due to limited insurance coverage for laser hair reduction, even in the most difficult-to-manage areas (eg, neck, jawline). Expanding access to military dermatologists, civilian dermatologists who are experienced with PFB and understand the impact and necessity of military waivers, and teledermatology services could help improve and streamline care. Other challenges include the subjective nature of documenting PFB disease severity, the need for validated assessment tools, a lack of standardized policies across military branches, and stigma. A standardized approach to documentation may reduce variability in how shaving waivers are evaluated across service branches, but at a minimum, clinicians should document the diagnosis, clinical findings, severity of PFB, and the treatment used. Having a waiver would help these service members focus on mastering critical skillsets and performing duties without the time pressures, angst, and expense dedicated to caring for and managing PFB.

Clinical and Policy Barriers

Unfortunately, service members with PFB or shaving waivers often face stigma that can hinder career advancement.⁶ In a recent analysis of 9339 US Air Force personnel, those with shaving waivers experienced longer times to promotion compared to those without waivers: in the waiver group, 94.47% were enlisted and 5.53% were officers; in the nonwaiver group, 72.11% were enlisted and 27.89% were officers (P=.0003).⁶ While delays in promotion were consistent across racial groups, most of the waiver holders identified as Black (64.8%), despite this demographic group representing only a small portion of the overall cohort (12.9%).⁶ Promotion delays may be linked to perceptions of unprofessionalism and exclusion from high-profile assignments, which notably require “the highest standards of military appearance and professional conduct.”¹¹ The burden of career-limiting shaving policies falls disproportionately on military personnel with PFB who self-identify as Black. Perceptions about unprofessional appearance or job readiness often unintentionally introduce bias, unjustly restricting career advancement.⁶

Safety Equipment and Shaving Standards

Conditions that potentially affect the use of masks and chemical defense equipment extend beyond the military. Firefighters and law enforcement officers generally are required to maintain a clean-shaven face for proper fit of respirator masks; the standard is that no respirator fit test shall be conducted if hair—including stubble, beards, mustaches, or sideburns—grows between the skin and the facepiece sealing surface, and any apparel interfering with a proper seal must be altered or removed.¹² This creates challenges for uniformed professionals with PFB who must manage their condition while adhering to safety requirements. Some endure long-term pain and scarring in order to comply, while others seek waivers to treat and prevent symptoms while also facing the stigma of doing so.¹³ One of the most effective treatments for PFB is to discontinue shaving,¹⁴ which may not be feasible for those in uniformed professions with strict grooming standards. Research on mask seal effectiveness in individuals with neatly trimmed beards or PFB remains limited.⁵ Studies evaluating mask fit across facial hair types and lengths are needed, along with the development of protective equipment that accommodates career-limiting conditions such as PFB, cystic acne, and acne keloidalis nuchae. This also may encourage development of equipment that does not induce such conditions (eg, mechanical acne from friction). These efforts would promote safety, scientific innovation for dermatologic follicular-based disorders, and overall quality of life for service members as well as increase their ability to serve without stigma. These developments also would positively impact other fields that require intermittent or full-time use of masks, including health care and some food service industries.

Final Thoughts

The disproportionate impact of PFB in the military highlights the need for improved access to treatment, culturally informed care, and policies that avoid penalizing service members with tightly coiled hair and a desire to serve. We discussed PFB management strategies, clinical features, and implications across various skin tones in a previous publication.¹⁴ It is important to consider insights from individuals with PFB who are serving in the military as well as the medical personnel who care for them. Ensuring or creating effective treatment options drives innovation, and evidence-based accommodation plans can help individuals in uniformed professions avoid choosing between PFB management and their career. Promoting awareness about the impact of PFB beyond the razor is key to reducing disparities and supporting excellence among those who serve and desire to continue to do so.

The impact of pseudofolliculitis barbae (PFB) on military service members and other uniformed professionals has been a topic of recent interest due to the announcement of the US Army’s new shaving rule in July 2025.¹ The policy prohibits permanent shaving waivers, requires medical re-evaluation of shaving profiles within 90 days, and allows for administrative separation if a service member accumulates shaving exceptions totaling more than 12 months over a 24-month period.² A common skin condition triggered or worsened by shaving, PFB causes painful bumps, pustules, and hyperpigmentation most often in the beard and cheek areas and negatively impacts quality of life. It disproportionately affects 45% to 83% of men in the United States, particularly those of African, Hispanic, or Middle Eastern descent.^3,4 Genetic factors, particularly tightly coiled or coarse curly hair, can predispose individuals to PFB. The most successful treatment for PFB is to stop shaving, but this conflicts with military shaving standards and interferes with the use of protective equipment (eg, masks). Herein, we highlight the adverse impact of PFB on military career progression and provide context for clinicians who treat patients with PFB, especially as policies recently have shifted to allow nonmilitary clinicians to evaluate PFB in service members.⁵

Shaving Waivers and Advancement

Pseudofolliculitis barbae disproportionately prolongs the time to advancement of many service members, and those with PFB also are overburdened by policy changes related to shaving.⁶ In the US military, nearly 18% of the active-duty force is Black,⁷ a population that is more susceptible to PFB. Military personnel may request PFB-related accommodations, including medical shaving waivers that vary by branch. Through a formal documentation process, waivers allow service members to maintain facial hair up to one-quarter inch in length.⁵ Previously, waivers could be temporary (eg, up to 90 days) or permanent as subjectively determined based on clinician-documented disease severity. Almost 65% of US Air Force medical shaving waivers are held by Black men, and PFB is one of the most common reasons.⁶ Notably, the US Navy discontinued permanent shaving waivers in October 2019.⁸ A US Marine Corps policy issued in March 2025 now allows administrative separation of service members with PFB if symptoms do not improve after a 1-year medical shaving waiver due to “incompatibility with service.”⁹ This change reversed a 2022 policy that protected Marines from separation based on PFB.¹⁰ A Marine Corps spokesperson stated that this change aims to clarify how medical conditions can impact uniform compliance and standardize medical condition management while prioritizing compliance and duty readiness.¹

Even in the absence of policy changes, obtaining a medical shaving waiver for PFB can be challenging. Service members may have little to no access to military dermatologists who specialize in management of PFB and experience long wait times for civilian network deferment. Service members seen in civilian clinics may have restricted treatment options due to limited insurance coverage for laser hair reduction, even in the most difficult-to-manage areas (eg, neck, jawline). Expanding access to military dermatologists, civilian dermatologists who are experienced with PFB and understand the impact and necessity of military waivers, and teledermatology services could help improve and streamline care. Other challenges include the subjective nature of documenting PFB disease severity, the need for validated assessment tools, a lack of standardized policies across military branches, and stigma. A standardized approach to documentation may reduce variability in how shaving waivers are evaluated across service branches, but at a minimum, clinicians should document the diagnosis, clinical findings, severity of PFB, and the treatment used. Having a waiver would help these service members focus on mastering critical skillsets and performing duties without the time pressures, angst, and expense dedicated to caring for and managing PFB.

Clinical and Policy Barriers

Unfortunately, service members with PFB or shaving waivers often face stigma that can hinder career advancement.⁶ In a recent analysis of 9339 US Air Force personnel, those with shaving waivers experienced longer times to promotion compared to those without waivers: in the waiver group, 94.47% were enlisted and 5.53% were officers; in the nonwaiver group, 72.11% were enlisted and 27.89% were officers (P=.0003).⁶ While delays in promotion were consistent across racial groups, most of the waiver holders identified as Black (64.8%), despite this demographic group representing only a small portion of the overall cohort (12.9%).⁶ Promotion delays may be linked to perceptions of unprofessionalism and exclusion from high-profile assignments, which notably require “the highest standards of military appearance and professional conduct.”¹¹ The burden of career-limiting shaving policies falls disproportionately on military personnel with PFB who self-identify as Black. Perceptions about unprofessional appearance or job readiness often unintentionally introduce bias, unjustly restricting career advancement.⁶

Safety Equipment and Shaving Standards

Conditions that potentially affect the use of masks and chemical defense equipment extend beyond the military. Firefighters and law enforcement officers generally are required to maintain a clean-shaven face for proper fit of respirator masks; the standard is that no respirator fit test shall be conducted if hair—including stubble, beards, mustaches, or sideburns—grows between the skin and the facepiece sealing surface, and any apparel interfering with a proper seal must be altered or removed.¹² This creates challenges for uniformed professionals with PFB who must manage their condition while adhering to safety requirements. Some endure long-term pain and scarring in order to comply, while others seek waivers to treat and prevent symptoms while also facing the stigma of doing so.¹³ One of the most effective treatments for PFB is to discontinue shaving,¹⁴ which may not be feasible for those in uniformed professions with strict grooming standards. Research on mask seal effectiveness in individuals with neatly trimmed beards or PFB remains limited.⁵ Studies evaluating mask fit across facial hair types and lengths are needed, along with the development of protective equipment that accommodates career-limiting conditions such as PFB, cystic acne, and acne keloidalis nuchae. This also may encourage development of equipment that does not induce such conditions (eg, mechanical acne from friction). These efforts would promote safety, scientific innovation for dermatologic follicular-based disorders, and overall quality of life for service members as well as increase their ability to serve without stigma. These developments also would positively impact other fields that require intermittent or full-time use of masks, including health care and some food service industries.

Final Thoughts

The disproportionate impact of PFB in the military highlights the need for improved access to treatment, culturally informed care, and policies that avoid penalizing service members with tightly coiled hair and a desire to serve. We discussed PFB management strategies, clinical features, and implications across various skin tones in a previous publication.¹⁴ It is important to consider insights from individuals with PFB who are serving in the military as well as the medical personnel who care for them. Ensuring or creating effective treatment options drives innovation, and evidence-based accommodation plans can help individuals in uniformed professions avoid choosing between PFB management and their career. Promoting awareness about the impact of PFB beyond the razor is key to reducing disparities and supporting excellence among those who serve and desire to continue to do so.

The impact of pseudofolliculitis barbae (PFB) on military service members and other uniformed professionals has been a topic of recent interest due to the announcement of the US Army’s new shaving rule in July 2025.¹ The policy prohibits permanent shaving waivers, requires medical re-evaluation of shaving profiles within 90 days, and allows for administrative separation if a service member accumulates shaving exceptions totaling more than 12 months over a 24-month period.² A common skin condition triggered or worsened by shaving, PFB causes painful bumps, pustules, and hyperpigmentation most often in the beard and cheek areas and negatively impacts quality of life. It disproportionately affects 45% to 83% of men in the United States, particularly those of African, Hispanic, or Middle Eastern descent.^3,4 Genetic factors, particularly tightly coiled or coarse curly hair, can predispose individuals to PFB. The most successful treatment for PFB is to stop shaving, but this conflicts with military shaving standards and interferes with the use of protective equipment (eg, masks). Herein, we highlight the adverse impact of PFB on military career progression and provide context for clinicians who treat patients with PFB, especially as policies recently have shifted to allow nonmilitary clinicians to evaluate PFB in service members.⁵

Shaving Waivers and Advancement

Pseudofolliculitis barbae disproportionately prolongs the time to advancement of many service members, and those with PFB also are overburdened by policy changes related to shaving.⁶ In the US military, nearly 18% of the active-duty force is Black,⁷ a population that is more susceptible to PFB. Military personnel may request PFB-related accommodations, including medical shaving waivers that vary by branch. Through a formal documentation process, waivers allow service members to maintain facial hair up to one-quarter inch in length.⁵ Previously, waivers could be temporary (eg, up to 90 days) or permanent as subjectively determined based on clinician-documented disease severity. Almost 65% of US Air Force medical shaving waivers are held by Black men, and PFB is one of the most common reasons.⁶ Notably, the US Navy discontinued permanent shaving waivers in October 2019.⁸ A US Marine Corps policy issued in March 2025 now allows administrative separation of service members with PFB if symptoms do not improve after a 1-year medical shaving waiver due to “incompatibility with service.”⁹ This change reversed a 2022 policy that protected Marines from separation based on PFB.¹⁰ A Marine Corps spokesperson stated that this change aims to clarify how medical conditions can impact uniform compliance and standardize medical condition management while prioritizing compliance and duty readiness.¹

Even in the absence of policy changes, obtaining a medical shaving waiver for PFB can be challenging. Service members may have little to no access to military dermatologists who specialize in management of PFB and experience long wait times for civilian network deferment. Service members seen in civilian clinics may have restricted treatment options due to limited insurance coverage for laser hair reduction, even in the most difficult-to-manage areas (eg, neck, jawline). Expanding access to military dermatologists, civilian dermatologists who are experienced with PFB and understand the impact and necessity of military waivers, and teledermatology services could help improve and streamline care. Other challenges include the subjective nature of documenting PFB disease severity, the need for validated assessment tools, a lack of standardized policies across military branches, and stigma. A standardized approach to documentation may reduce variability in how shaving waivers are evaluated across service branches, but at a minimum, clinicians should document the diagnosis, clinical findings, severity of PFB, and the treatment used. Having a waiver would help these service members focus on mastering critical skillsets and performing duties without the time pressures, angst, and expense dedicated to caring for and managing PFB.

Clinical and Policy Barriers

Unfortunately, service members with PFB or shaving waivers often face stigma that can hinder career advancement.⁶ In a recent analysis of 9339 US Air Force personnel, those with shaving waivers experienced longer times to promotion compared to those without waivers: in the waiver group, 94.47% were enlisted and 5.53% were officers; in the nonwaiver group, 72.11% were enlisted and 27.89% were officers (P=.0003).⁶ While delays in promotion were consistent across racial groups, most of the waiver holders identified as Black (64.8%), despite this demographic group representing only a small portion of the overall cohort (12.9%).⁶ Promotion delays may be linked to perceptions of unprofessionalism and exclusion from high-profile assignments, which notably require “the highest standards of military appearance and professional conduct.”¹¹ The burden of career-limiting shaving policies falls disproportionately on military personnel with PFB who self-identify as Black. Perceptions about unprofessional appearance or job readiness often unintentionally introduce bias, unjustly restricting career advancement.⁶

Safety Equipment and Shaving Standards

Conditions that potentially affect the use of masks and chemical defense equipment extend beyond the military. Firefighters and law enforcement officers generally are required to maintain a clean-shaven face for proper fit of respirator masks; the standard is that no respirator fit test shall be conducted if hair—including stubble, beards, mustaches, or sideburns—grows between the skin and the facepiece sealing surface, and any apparel interfering with a proper seal must be altered or removed.¹² This creates challenges for uniformed professionals with PFB who must manage their condition while adhering to safety requirements. Some endure long-term pain and scarring in order to comply, while others seek waivers to treat and prevent symptoms while also facing the stigma of doing so.¹³ One of the most effective treatments for PFB is to discontinue shaving,¹⁴ which may not be feasible for those in uniformed professions with strict grooming standards. Research on mask seal effectiveness in individuals with neatly trimmed beards or PFB remains limited.⁵ Studies evaluating mask fit across facial hair types and lengths are needed, along with the development of protective equipment that accommodates career-limiting conditions such as PFB, cystic acne, and acne keloidalis nuchae. This also may encourage development of equipment that does not induce such conditions (eg, mechanical acne from friction). These efforts would promote safety, scientific innovation for dermatologic follicular-based disorders, and overall quality of life for service members as well as increase their ability to serve without stigma. These developments also would positively impact other fields that require intermittent or full-time use of masks, including health care and some food service industries.

Final Thoughts

The disproportionate impact of PFB in the military highlights the need for improved access to treatment, culturally informed care, and policies that avoid penalizing service members with tightly coiled hair and a desire to serve. We discussed PFB management strategies, clinical features, and implications across various skin tones in a previous publication.¹⁴ It is important to consider insights from individuals with PFB who are serving in the military as well as the medical personnel who care for them. Ensuring or creating effective treatment options drives innovation, and evidence-based accommodation plans can help individuals in uniformed professions avoid choosing between PFB management and their career. Promoting awareness about the impact of PFB beyond the razor is key to reducing disparities and supporting excellence among those who serve and desire to continue to do so.

Federal grants have supported cutting-edge research in scientific and biomedical fields since the mid-20th century, fueling public health breakthroughs and health innovations. This crucial support has been greatly diminished in recent months with deep cuts to federal research dollars.

As these acute policy changes continue to disrupt academic institutions and their investigators, introducing financial strain and operational uncertainty, the importance of research support from professional societies and foundations has become increasingly evident. Their targeted funding plays a critical role in sustaining biomedical research, which directly impacts clinical innovation and patient care. As one example, the AGA Research Foundation provides over $2 million annually to spur discoveries in gastroenterology and hepatology. This vital research support, awarded to 74 unique recipients (including 7 early-career Research Scholar Award recipients) in 2025, represents one of the most important investments that AGA makes in the future of gastroenterology and the patients we treat.

While foundation awards such as these cannot completely close the federal funding gap, they serve as an important lifeline both in supporting the core work of early career and established investigators in an uncertain funding environment and in funding high-risk, high-reward research that more conservative funders are often hesitant to invest in. Please consider joining me in contributing to the AGA Research Foundation to support its important work – now more than ever, the funding it provides has tremendous impact.

In this issue of GI & Hepatology News, we update you on the FDA’s recent approval of semaglutide as a treatment for MASH with fibrosis and highlight a recent target trial emulation study that casts doubt on our traditional understanding regarding the link between common medications such as PPIs and NSAIDs and microscopic colitis in older adults. We also summarize newly-released, global guidelines for pregnancy and IBD, which deserve a careful read. In this month’s Member Spotlight, we feature Pascale White, MD, MBA, MS (Mount Sinai), a recent recipient of the AGA-Pfizer Beacon of Hope Award for Gender and Health Equity, who shares her inspirational work to improve colorectal cancer screening among underserved, high-risk patients in East Harlem. We hope you enjoy this and all the exciting content in our October issue.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

Federal grants have supported cutting-edge research in scientific and biomedical fields since the mid-20th century, fueling public health breakthroughs and health innovations. This crucial support has been greatly diminished in recent months with deep cuts to federal research dollars.

As these acute policy changes continue to disrupt academic institutions and their investigators, introducing financial strain and operational uncertainty, the importance of research support from professional societies and foundations has become increasingly evident. Their targeted funding plays a critical role in sustaining biomedical research, which directly impacts clinical innovation and patient care. As one example, the AGA Research Foundation provides over $2 million annually to spur discoveries in gastroenterology and hepatology. This vital research support, awarded to 74 unique recipients (including 7 early-career Research Scholar Award recipients) in 2025, represents one of the most important investments that AGA makes in the future of gastroenterology and the patients we treat.

While foundation awards such as these cannot completely close the federal funding gap, they serve as an important lifeline both in supporting the core work of early career and established investigators in an uncertain funding environment and in funding high-risk, high-reward research that more conservative funders are often hesitant to invest in. Please consider joining me in contributing to the AGA Research Foundation to support its important work – now more than ever, the funding it provides has tremendous impact.

In this issue of GI & Hepatology News, we update you on the FDA’s recent approval of semaglutide as a treatment for MASH with fibrosis and highlight a recent target trial emulation study that casts doubt on our traditional understanding regarding the link between common medications such as PPIs and NSAIDs and microscopic colitis in older adults. We also summarize newly-released, global guidelines for pregnancy and IBD, which deserve a careful read. In this month’s Member Spotlight, we feature Pascale White, MD, MBA, MS (Mount Sinai), a recent recipient of the AGA-Pfizer Beacon of Hope Award for Gender and Health Equity, who shares her inspirational work to improve colorectal cancer screening among underserved, high-risk patients in East Harlem. We hope you enjoy this and all the exciting content in our October issue.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

Federal grants have supported cutting-edge research in scientific and biomedical fields since the mid-20th century, fueling public health breakthroughs and health innovations. This crucial support has been greatly diminished in recent months with deep cuts to federal research dollars.

As these acute policy changes continue to disrupt academic institutions and their investigators, introducing financial strain and operational uncertainty, the importance of research support from professional societies and foundations has become increasingly evident. Their targeted funding plays a critical role in sustaining biomedical research, which directly impacts clinical innovation and patient care. As one example, the AGA Research Foundation provides over $2 million annually to spur discoveries in gastroenterology and hepatology. This vital research support, awarded to 74 unique recipients (including 7 early-career Research Scholar Award recipients) in 2025, represents one of the most important investments that AGA makes in the future of gastroenterology and the patients we treat.

While foundation awards such as these cannot completely close the federal funding gap, they serve as an important lifeline both in supporting the core work of early career and established investigators in an uncertain funding environment and in funding high-risk, high-reward research that more conservative funders are often hesitant to invest in. Please consider joining me in contributing to the AGA Research Foundation to support its important work – now more than ever, the funding it provides has tremendous impact.

In this issue of GI & Hepatology News, we update you on the FDA’s recent approval of semaglutide as a treatment for MASH with fibrosis and highlight a recent target trial emulation study that casts doubt on our traditional understanding regarding the link between common medications such as PPIs and NSAIDs and microscopic colitis in older adults. We also summarize newly-released, global guidelines for pregnancy and IBD, which deserve a careful read. In this month’s Member Spotlight, we feature Pascale White, MD, MBA, MS (Mount Sinai), a recent recipient of the AGA-Pfizer Beacon of Hope Award for Gender and Health Equity, who shares her inspirational work to improve colorectal cancer screening among underserved, high-risk patients in East Harlem. We hope you enjoy this and all the exciting content in our October issue.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

If I have seen further, it is by standing on the shoulders of giants.

Sir Isaac Newton (1642-1727) ¹

Early in residency, I decided I only wanted to work at the US Department of Veterans Affairs (VA). It was a way to follow the example of service that my parents, an Army doctor and nurse, had set. I spent much of my residency, including all of my last year of training, at a VA medical center, hoping a vacancy would open in the psychiatry service. In those days, VA jobs were hard to come by; doctors spent their entire careers in the system, only retiring after decades of commitment to its unique mission. Finally, close to graduation, one of my favorite attending physicians left his post. After mountains of paperwork and running the human resources obstacle course with the usual stumbles, I arrived at my dream job as a VA psychiatrist.

So, it is with immense sadness and even shock that I read a recent ProPublica article reporting that from January to March 2025 almost 40% of the physicians who received employment offers from the Veterans Health Administration (VHA) declined the positions.² Medical media rapidly picked up the story, likely further discouraging potential applicants.³

There have always been health care professionals (HCPs) who had zero interest in working for the VA. Medical students and residents often have a love/hate relationship with the VA, with some trainees not having the patience for the behemoth pace of the bureaucracy or finding the old-style physical environment and more relaxed pace antiquated and inefficient.

The reasons doctors are saying no to VA employment at 4 times the previous rate are different and more disturbing. According to ProPublica, VA officials in Texas reported in a June internal presentation that about 90 people had turned down job offers due to the “uncertainty of reorganization.”² They reported that low morale was causing existing employees to recommend against working at the VA. My own anecdotal experience is similar: contrary to prior years, few residents, if any, are interested in working at the VA because of concerns about the stability of employment and the direction of its organizational culture.

It is fair to question the objectivity of the ProPublica report. However, the latest VA Office of the Inspector General (OIG) analysis of staffing had similar findings. “Despite the ability to make noncompetitive appointments for such occupations, VHA continues to experience severe occupational staffing shortages for these occupations that are fundamental to the delivery of health care.” The 4434 severe occupational shortage figures in fiscal year (FY) 2025 were 50% higher than in FY 2024.⁴ OIG reported that 57% of facilities noted severe occupational staffing shortages for psychology, making it the most frequently reported clinical shortage.

At this critical juncture, when new health care professional energy is not flowing into the VHA, there is an unprecedented drain of the lifeblood of any system—the departure of the bearers of institutional memory. Early and scheduled retirements, the deferred resignation program, and severance have decimated the ranks of senior HCPs, experienced leaders, and career clinicians. ProPublica noted the loss of 600 doctors and 1900 nurses at the VHA so far in 2025.² Internal VA data from exit interviews suggest similar motivations. Many cited lack of trust and confidence in senior leaders and job stress/pressure.⁵

It should be noted the VA has an alternative and plausible explanation for the expected departure of 30,000 employees. They argue that the VHA was overstaffed and the increased workforce decreased the efficiency of service. Voluntary separation from employment, VA contends, has avoided the need for a far more disruptive reduction in force. VA leaders avow that downsizing has not adversely impacted its ability to deliver high-quality health care and benefits and they assert that a reduction in red tape will enable VA to provide easier access to care. VA Secretary Doug Collins has concluded that because of these difficult but necessary changes, “VA is headed in the right direction.”⁶

What is institutional memory, and why is it important? “The core of institutional memory is collective awareness and understanding of a collective set of facts, concepts, experiences, and know-how,” Bhugra and Ventriglio explain. “These are all held collectively at various levels in any given institution. Thus, collective memory or history can be utilized to build on what has gone before and how we take things forward.”⁷

The authors of this quote offer a modern twist on what Sir Isaac Newton described in more metaphorical language in the epigraph: to survive, and even more to thrive, an enterprise must have those who have accumulated technical knowledge and professional wisdom as well as those who assume responsibility for appropriating and adding to this storehouse of operational skill, expertise, unique cultural values, and ethical commitments. The VHA is losing its instructors and students of institutional memory which deals a serious blow to the stability and vitality of any learning health system.⁶ As Bhugra and Ventriglio put it, institutional memory identifies “what has worked in delivering the aims in the past and what has not, thereby ensuring the lessons learnt are remembered and passed on to the next generation.”⁷

Nearly every week, at all levels of the agency, I have encountered this exodus of builders and bearers of institutional memory. Those who have left did so for many of the same reasons cited by those who declined to come, leaving incalculable gaps at both ends of the career spectrum. Both the old and new are essential for organizational resilience: fresh ideas enable an institution to be agile in responding to challenges, while operational savvy ensures responses are ecologically aligned with the organizational mission.⁸

The dire shortage of HCPs—especially in mental health and primary care—has opened up unprecedented opportunities.⁹ Colleagues have noted that with only a little searching they found multiple lucrative positions. Once, HCPs picked the VA because they valued the commitment to public service and being part of a community of education and research more than fame or fortune. Having the best benefits packages in the industry only reinforced its value. 

Even so, surpassing a genius such as Sir Isaac Newton, writing to a scientific competitor, Robert Hooke, recognized that progress and discovery in science and medicine are nigh well impossible without the collective achievements housed in institutional memory.¹ It was inspiring teachers and attending physicians—Newton’s giants—who attracted the best and brightest in medicine and nursing, other HCPs, and research, to the VA, where they could participate in a transactive organizational learning process from their seniors, and then grow that fund of knowledge to improve patient care, educate their learners, and innovate. What will happen when there are no longer shoulders of giants or anyone to stand on them?

If I have seen further, it is by standing on the shoulders of giants.

Sir Isaac Newton (1642-1727) ¹

Early in residency, I decided I only wanted to work at the US Department of Veterans Affairs (VA). It was a way to follow the example of service that my parents, an Army doctor and nurse, had set. I spent much of my residency, including all of my last year of training, at a VA medical center, hoping a vacancy would open in the psychiatry service. In those days, VA jobs were hard to come by; doctors spent their entire careers in the system, only retiring after decades of commitment to its unique mission. Finally, close to graduation, one of my favorite attending physicians left his post. After mountains of paperwork and running the human resources obstacle course with the usual stumbles, I arrived at my dream job as a VA psychiatrist.

So, it is with immense sadness and even shock that I read a recent ProPublica article reporting that from January to March 2025 almost 40% of the physicians who received employment offers from the Veterans Health Administration (VHA) declined the positions.² Medical media rapidly picked up the story, likely further discouraging potential applicants.³

There have always been health care professionals (HCPs) who had zero interest in working for the VA. Medical students and residents often have a love/hate relationship with the VA, with some trainees not having the patience for the behemoth pace of the bureaucracy or finding the old-style physical environment and more relaxed pace antiquated and inefficient.

The reasons doctors are saying no to VA employment at 4 times the previous rate are different and more disturbing. According to ProPublica, VA officials in Texas reported in a June internal presentation that about 90 people had turned down job offers due to the “uncertainty of reorganization.”² They reported that low morale was causing existing employees to recommend against working at the VA. My own anecdotal experience is similar: contrary to prior years, few residents, if any, are interested in working at the VA because of concerns about the stability of employment and the direction of its organizational culture.

It is fair to question the objectivity of the ProPublica report. However, the latest VA Office of the Inspector General (OIG) analysis of staffing had similar findings. “Despite the ability to make noncompetitive appointments for such occupations, VHA continues to experience severe occupational staffing shortages for these occupations that are fundamental to the delivery of health care.” The 4434 severe occupational shortage figures in fiscal year (FY) 2025 were 50% higher than in FY 2024.⁴ OIG reported that 57% of facilities noted severe occupational staffing shortages for psychology, making it the most frequently reported clinical shortage.

At this critical juncture, when new health care professional energy is not flowing into the VHA, there is an unprecedented drain of the lifeblood of any system—the departure of the bearers of institutional memory. Early and scheduled retirements, the deferred resignation program, and severance have decimated the ranks of senior HCPs, experienced leaders, and career clinicians. ProPublica noted the loss of 600 doctors and 1900 nurses at the VHA so far in 2025.² Internal VA data from exit interviews suggest similar motivations. Many cited lack of trust and confidence in senior leaders and job stress/pressure.⁵

It should be noted the VA has an alternative and plausible explanation for the expected departure of 30,000 employees. They argue that the VHA was overstaffed and the increased workforce decreased the efficiency of service. Voluntary separation from employment, VA contends, has avoided the need for a far more disruptive reduction in force. VA leaders avow that downsizing has not adversely impacted its ability to deliver high-quality health care and benefits and they assert that a reduction in red tape will enable VA to provide easier access to care. VA Secretary Doug Collins has concluded that because of these difficult but necessary changes, “VA is headed in the right direction.”⁶

What is institutional memory, and why is it important? “The core of institutional memory is collective awareness and understanding of a collective set of facts, concepts, experiences, and know-how,” Bhugra and Ventriglio explain. “These are all held collectively at various levels in any given institution. Thus, collective memory or history can be utilized to build on what has gone before and how we take things forward.”⁷

The authors of this quote offer a modern twist on what Sir Isaac Newton described in more metaphorical language in the epigraph: to survive, and even more to thrive, an enterprise must have those who have accumulated technical knowledge and professional wisdom as well as those who assume responsibility for appropriating and adding to this storehouse of operational skill, expertise, unique cultural values, and ethical commitments. The VHA is losing its instructors and students of institutional memory which deals a serious blow to the stability and vitality of any learning health system.⁶ As Bhugra and Ventriglio put it, institutional memory identifies “what has worked in delivering the aims in the past and what has not, thereby ensuring the lessons learnt are remembered and passed on to the next generation.”⁷

Nearly every week, at all levels of the agency, I have encountered this exodus of builders and bearers of institutional memory. Those who have left did so for many of the same reasons cited by those who declined to come, leaving incalculable gaps at both ends of the career spectrum. Both the old and new are essential for organizational resilience: fresh ideas enable an institution to be agile in responding to challenges, while operational savvy ensures responses are ecologically aligned with the organizational mission.⁸

The dire shortage of HCPs—especially in mental health and primary care—has opened up unprecedented opportunities.⁹ Colleagues have noted that with only a little searching they found multiple lucrative positions. Once, HCPs picked the VA because they valued the commitment to public service and being part of a community of education and research more than fame or fortune. Having the best benefits packages in the industry only reinforced its value. 

Even so, surpassing a genius such as Sir Isaac Newton, writing to a scientific competitor, Robert Hooke, recognized that progress and discovery in science and medicine are nigh well impossible without the collective achievements housed in institutional memory.¹ It was inspiring teachers and attending physicians—Newton’s giants—who attracted the best and brightest in medicine and nursing, other HCPs, and research, to the VA, where they could participate in a transactive organizational learning process from their seniors, and then grow that fund of knowledge to improve patient care, educate their learners, and innovate. What will happen when there are no longer shoulders of giants or anyone to stand on them?

If I have seen further, it is by standing on the shoulders of giants.

Sir Isaac Newton (1642-1727) ¹

Early in residency, I decided I only wanted to work at the US Department of Veterans Affairs (VA). It was a way to follow the example of service that my parents, an Army doctor and nurse, had set. I spent much of my residency, including all of my last year of training, at a VA medical center, hoping a vacancy would open in the psychiatry service. In those days, VA jobs were hard to come by; doctors spent their entire careers in the system, only retiring after decades of commitment to its unique mission. Finally, close to graduation, one of my favorite attending physicians left his post. After mountains of paperwork and running the human resources obstacle course with the usual stumbles, I arrived at my dream job as a VA psychiatrist.

So, it is with immense sadness and even shock that I read a recent ProPublica article reporting that from January to March 2025 almost 40% of the physicians who received employment offers from the Veterans Health Administration (VHA) declined the positions.² Medical media rapidly picked up the story, likely further discouraging potential applicants.³

There have always been health care professionals (HCPs) who had zero interest in working for the VA. Medical students and residents often have a love/hate relationship with the VA, with some trainees not having the patience for the behemoth pace of the bureaucracy or finding the old-style physical environment and more relaxed pace antiquated and inefficient.

The reasons doctors are saying no to VA employment at 4 times the previous rate are different and more disturbing. According to ProPublica, VA officials in Texas reported in a June internal presentation that about 90 people had turned down job offers due to the “uncertainty of reorganization.”² They reported that low morale was causing existing employees to recommend against working at the VA. My own anecdotal experience is similar: contrary to prior years, few residents, if any, are interested in working at the VA because of concerns about the stability of employment and the direction of its organizational culture.

It is fair to question the objectivity of the ProPublica report. However, the latest VA Office of the Inspector General (OIG) analysis of staffing had similar findings. “Despite the ability to make noncompetitive appointments for such occupations, VHA continues to experience severe occupational staffing shortages for these occupations that are fundamental to the delivery of health care.” The 4434 severe occupational shortage figures in fiscal year (FY) 2025 were 50% higher than in FY 2024.⁴ OIG reported that 57% of facilities noted severe occupational staffing shortages for psychology, making it the most frequently reported clinical shortage.

At this critical juncture, when new health care professional energy is not flowing into the VHA, there is an unprecedented drain of the lifeblood of any system—the departure of the bearers of institutional memory. Early and scheduled retirements, the deferred resignation program, and severance have decimated the ranks of senior HCPs, experienced leaders, and career clinicians. ProPublica noted the loss of 600 doctors and 1900 nurses at the VHA so far in 2025.² Internal VA data from exit interviews suggest similar motivations. Many cited lack of trust and confidence in senior leaders and job stress/pressure.⁵

It should be noted the VA has an alternative and plausible explanation for the expected departure of 30,000 employees. They argue that the VHA was overstaffed and the increased workforce decreased the efficiency of service. Voluntary separation from employment, VA contends, has avoided the need for a far more disruptive reduction in force. VA leaders avow that downsizing has not adversely impacted its ability to deliver high-quality health care and benefits and they assert that a reduction in red tape will enable VA to provide easier access to care. VA Secretary Doug Collins has concluded that because of these difficult but necessary changes, “VA is headed in the right direction.”⁶

What is institutional memory, and why is it important? “The core of institutional memory is collective awareness and understanding of a collective set of facts, concepts, experiences, and know-how,” Bhugra and Ventriglio explain. “These are all held collectively at various levels in any given institution. Thus, collective memory or history can be utilized to build on what has gone before and how we take things forward.”⁷

The authors of this quote offer a modern twist on what Sir Isaac Newton described in more metaphorical language in the epigraph: to survive, and even more to thrive, an enterprise must have those who have accumulated technical knowledge and professional wisdom as well as those who assume responsibility for appropriating and adding to this storehouse of operational skill, expertise, unique cultural values, and ethical commitments. The VHA is losing its instructors and students of institutional memory which deals a serious blow to the stability and vitality of any learning health system.⁶ As Bhugra and Ventriglio put it, institutional memory identifies “what has worked in delivering the aims in the past and what has not, thereby ensuring the lessons learnt are remembered and passed on to the next generation.”⁷

Nearly every week, at all levels of the agency, I have encountered this exodus of builders and bearers of institutional memory. Those who have left did so for many of the same reasons cited by those who declined to come, leaving incalculable gaps at both ends of the career spectrum. Both the old and new are essential for organizational resilience: fresh ideas enable an institution to be agile in responding to challenges, while operational savvy ensures responses are ecologically aligned with the organizational mission.⁸

The dire shortage of HCPs—especially in mental health and primary care—has opened up unprecedented opportunities.⁹ Colleagues have noted that with only a little searching they found multiple lucrative positions. Once, HCPs picked the VA because they valued the commitment to public service and being part of a community of education and research more than fame or fortune. Having the best benefits packages in the industry only reinforced its value. 

Even so, surpassing a genius such as Sir Isaac Newton, writing to a scientific competitor, Robert Hooke, recognized that progress and discovery in science and medicine are nigh well impossible without the collective achievements housed in institutional memory.¹ It was inspiring teachers and attending physicians—Newton’s giants—who attracted the best and brightest in medicine and nursing, other HCPs, and research, to the VA, where they could participate in a transactive organizational learning process from their seniors, and then grow that fund of knowledge to improve patient care, educate their learners, and innovate. What will happen when there are no longer shoulders of giants or anyone to stand on them?

Prurigo nodularis (PN) is a chronic, severely pruritic neuroimmunologic skin disorder characterized by multiple firm hyperkeratotic nodules and intense pruritus, often leading to considerable impairment in quality of life and increased rates of depression and anxiety.¹ It is considered difficult to treat due to its complex pathogenesis, the severity and chronicity of pruritus, and the limited efficacy of conventional therapies.^2,3 The disease is driven by a self-perpetuating itch-scratch cycle, underpinned by dysregulation of both immune and neural pathways including type 2 (interleukin [IL] 4, IL-13, IL-31), Th17, and Th22 cytokines as well as neuropeptides and altered cutaneous nerve architecture.^1,3 This results in persistent severe pruritus and nodular lesions that are highly refractory to standard treatments.¹ Conventional therapies (eg, locally acting agents, phototherapy, and systemic immunomodulators and neuromodulators) have varied efficacy and notable adverse effect profiles.³ While the approval of targeted biologics has transformed the therapeutic landscape, several other treatment options also are being explored in clinical trials. Herein, we review all recently approved therapies as well as emerging treatments currently under investigation.

Dupilumab

Dupilumab, the first therapy for PN approved by the US Food and Drug Administration (FDA) in 2022—is a monoclonal antibody that inhibits signaling of IL-4 and IL-13, key drivers of type 2 inflammation implicated in PN pathogenesis.^4,5 In 2 pivotal phase 3 randomized controlled trials (LIBERTY-PN PRIME and PRIME2),⁵ dupilumab demonstrated notable efficacy in adults with moderate to severe PN. A reduction of 4 points or more on the Worst Itch Numeric Rating Scale (WI-NRS) was achieved by 60.0% (45/75) of patients treated with dupilumab at week 24 compared with 18.4% (14/76) receiving placebo in the PRIME trial. In PRIME2, the same outcome was achieved by 37.2% (29/78) of patients receiving dupilumab at week 12 compared with 22.0% (18/82) of patients receiving placebo.⁵ Dupilumab also led to a greater proportion of patients achieving a substantial reduction in nodule count (≤5 nodules) and improved quality of life compared with placebo.^5,6 The safety profile of dupilumab for treatment of PN was favorable and consistent with prior experience in atopic dermatitis; conjunctivitis was the most common adverse event.^5,6

Nemolizumab

Nemolizumab, an IL-31 receptor A antagonist, is the most recent agent approved by the FDA for PN in 2024.⁷ In the OLYMPIA 1 and OLYMPIA 2 phase 3 trials,⁸ nemolizumab produced a clinically meaningful reduction in itch (defined as a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score) in 56.3% (103/183) of patients at week 16 compared with 20.9% (19/91) receiving placebo. Additionally, 37.7% (69/183) of patients receiving nemolizumab achieved clear or almost clear skin (Investigator’s Global Assessment score of 0 or 1 with a ≥2-point reduction) vs 11.0% with placebo (both P<.001). Benefits were observed as early as week 4, including rapid improvements in itch, sleep disturbance, and nodule count.⁸ Nemolizumab also improved quality of life and reduced symptoms of anxiety and depression. The safety profile was favorable, with headache and atopic dermatitis the most common adverse events; serious adverse events were infrequent and similar between groups.⁸

Abrocitinib

Abrocitinib, an oral selective Janus kinase 1 inhibitor, is an investigational therapy for PN and currently has not been approved by the FDA for this indication. In a phase 2 open-label trial, abrocitinib 200 mg daily for 12 weeks led to a 78.3% reduction in weekly Peak Pruritus Numerical Rating Scale scores in PN, with 80.0% (8/10) of patients achieving a clinically meaningful improvement of 4 points or higher. Nodule counts and quality of life also improved, with an onset of itch relief as early as week 2. The safety profile was favorable, with acneform eruptions the most common adverse event and no serious adverse events reported⁹; however, these results are based on small, nonrandomized studies and require confirmation in larger randomized controlled trials before abrocitinib can be considered a standard therapy for PN.

Cryosim-1

Transient receptor potential melastatin 8 (TRPM8) is a cold-sensing ion channel found in unmyelinated sensory neurons within the dorsal root and trigeminal ­ganglia.¹⁰ It is activated by cool temperatures (15-28 °C) and compounds such as menthol, leading to calcium influx and a cooling sensation. In a randomized, double-blind, vehicle-controlled trial, researchers investigated the efficacy of cryosim-1 (a synthetic TRPM8 agonist) in treating PN.¹⁰ Thirty patients were enrolled, with 18 (60.0%) receiving cryosim-1 and 12 (40.0%) receiving placebo over 8 weeks. By week 8, cryosim-1 significantly reduced itch severity (mean numerical rating scale score postapplication, 2.8 vs 4.3; P=.031) and improved sleep disturbances (2.2 vs 4.2; P=.031) compared to placebo. Patients reported higher satisfaction with itch relief, and no adverse effects were observed. The study concluded that cryosim-1 is a safe, effective topical therapy for PN, likely working by interrupting the itch-scratch cycle and potentially modulating inflammatory pathways involved in chronic itch.¹⁰

Nalbuphine

Nalbuphine is a κ opioid receptor agonist and μ opioid receptor antagonist that has been investigated for the treatment of PN.¹¹ In a phase 2 randomized controlled trial, oral nalbuphine extended release (NAL-ER) 162 mg twice daily provided measurable antipruritic efficacy, with 44.4% (8/18) of patients achieving at least a 30% reduction in 7-day WI-NRS at week 10 compared with 36.4% (8/22) in the placebo group. Among those who completed the study, 66.7% (8/12) of patients receiving NAL-ER 162 mg achieved significant itch reduction vs 40% (8/20) receiving placebo (P=.03). At least a 50% reduction in WI-NRS was achieved by 33.3% (6/18) of patients receiving NAL-ER 162 mg twice daily. Extended open-label treatment was associated with further improvements in itch and lesion activity. Adverse events were mostly mild to moderate (eg, nausea, dizziness, headache, and fatigue) and occurred during dose titration. Physiologic opioid withdrawal symptoms were limited and resolved within a few days of discontinuing the medication.¹¹

Final Thoughts

In conclusion, PN remains one of the most challenging chronic dermatologic conditions to manage and is driven by a complex interplay of neuroimmune mechanisms and resistance to many conventional therapies. The approval of dupilumab and nemolizumab has marked a pivotal shift in the therapeutic landscape, offering hope to patients who previously had limited options^5,8; however, the burden of PN remains substantial, and many patients continue to experience relentless itch, poor sleep, and reduced quality of life.¹ Emerging therapies such as TRPM8 agonists, Janus kinase inhibitors, and opioid modulators represent promising additions to the treatment options, targeting novel pathways beyond traditional immunosuppression.^9-11

Prurigo nodularis (PN) is a chronic, severely pruritic neuroimmunologic skin disorder characterized by multiple firm hyperkeratotic nodules and intense pruritus, often leading to considerable impairment in quality of life and increased rates of depression and anxiety.¹ It is considered difficult to treat due to its complex pathogenesis, the severity and chronicity of pruritus, and the limited efficacy of conventional therapies.^2,3 The disease is driven by a self-perpetuating itch-scratch cycle, underpinned by dysregulation of both immune and neural pathways including type 2 (interleukin [IL] 4, IL-13, IL-31), Th17, and Th22 cytokines as well as neuropeptides and altered cutaneous nerve architecture.^1,3 This results in persistent severe pruritus and nodular lesions that are highly refractory to standard treatments.¹ Conventional therapies (eg, locally acting agents, phototherapy, and systemic immunomodulators and neuromodulators) have varied efficacy and notable adverse effect profiles.³ While the approval of targeted biologics has transformed the therapeutic landscape, several other treatment options also are being explored in clinical trials. Herein, we review all recently approved therapies as well as emerging treatments currently under investigation.

Dupilumab

Dupilumab, the first therapy for PN approved by the US Food and Drug Administration (FDA) in 2022—is a monoclonal antibody that inhibits signaling of IL-4 and IL-13, key drivers of type 2 inflammation implicated in PN pathogenesis.^4,5 In 2 pivotal phase 3 randomized controlled trials (LIBERTY-PN PRIME and PRIME2),⁵ dupilumab demonstrated notable efficacy in adults with moderate to severe PN. A reduction of 4 points or more on the Worst Itch Numeric Rating Scale (WI-NRS) was achieved by 60.0% (45/75) of patients treated with dupilumab at week 24 compared with 18.4% (14/76) receiving placebo in the PRIME trial. In PRIME2, the same outcome was achieved by 37.2% (29/78) of patients receiving dupilumab at week 12 compared with 22.0% (18/82) of patients receiving placebo.⁵ Dupilumab also led to a greater proportion of patients achieving a substantial reduction in nodule count (≤5 nodules) and improved quality of life compared with placebo.^5,6 The safety profile of dupilumab for treatment of PN was favorable and consistent with prior experience in atopic dermatitis; conjunctivitis was the most common adverse event.^5,6

Nemolizumab

Nemolizumab, an IL-31 receptor A antagonist, is the most recent agent approved by the FDA for PN in 2024.⁷ In the OLYMPIA 1 and OLYMPIA 2 phase 3 trials,⁸ nemolizumab produced a clinically meaningful reduction in itch (defined as a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score) in 56.3% (103/183) of patients at week 16 compared with 20.9% (19/91) receiving placebo. Additionally, 37.7% (69/183) of patients receiving nemolizumab achieved clear or almost clear skin (Investigator’s Global Assessment score of 0 or 1 with a ≥2-point reduction) vs 11.0% with placebo (both P<.001). Benefits were observed as early as week 4, including rapid improvements in itch, sleep disturbance, and nodule count.⁸ Nemolizumab also improved quality of life and reduced symptoms of anxiety and depression. The safety profile was favorable, with headache and atopic dermatitis the most common adverse events; serious adverse events were infrequent and similar between groups.⁸

Abrocitinib

Abrocitinib, an oral selective Janus kinase 1 inhibitor, is an investigational therapy for PN and currently has not been approved by the FDA for this indication. In a phase 2 open-label trial, abrocitinib 200 mg daily for 12 weeks led to a 78.3% reduction in weekly Peak Pruritus Numerical Rating Scale scores in PN, with 80.0% (8/10) of patients achieving a clinically meaningful improvement of 4 points or higher. Nodule counts and quality of life also improved, with an onset of itch relief as early as week 2. The safety profile was favorable, with acneform eruptions the most common adverse event and no serious adverse events reported⁹; however, these results are based on small, nonrandomized studies and require confirmation in larger randomized controlled trials before abrocitinib can be considered a standard therapy for PN.

Cryosim-1

Transient receptor potential melastatin 8 (TRPM8) is a cold-sensing ion channel found in unmyelinated sensory neurons within the dorsal root and trigeminal ­ganglia.¹⁰ It is activated by cool temperatures (15-28 °C) and compounds such as menthol, leading to calcium influx and a cooling sensation. In a randomized, double-blind, vehicle-controlled trial, researchers investigated the efficacy of cryosim-1 (a synthetic TRPM8 agonist) in treating PN.¹⁰ Thirty patients were enrolled, with 18 (60.0%) receiving cryosim-1 and 12 (40.0%) receiving placebo over 8 weeks. By week 8, cryosim-1 significantly reduced itch severity (mean numerical rating scale score postapplication, 2.8 vs 4.3; P=.031) and improved sleep disturbances (2.2 vs 4.2; P=.031) compared to placebo. Patients reported higher satisfaction with itch relief, and no adverse effects were observed. The study concluded that cryosim-1 is a safe, effective topical therapy for PN, likely working by interrupting the itch-scratch cycle and potentially modulating inflammatory pathways involved in chronic itch.¹⁰

Nalbuphine

Nalbuphine is a κ opioid receptor agonist and μ opioid receptor antagonist that has been investigated for the treatment of PN.¹¹ In a phase 2 randomized controlled trial, oral nalbuphine extended release (NAL-ER) 162 mg twice daily provided measurable antipruritic efficacy, with 44.4% (8/18) of patients achieving at least a 30% reduction in 7-day WI-NRS at week 10 compared with 36.4% (8/22) in the placebo group. Among those who completed the study, 66.7% (8/12) of patients receiving NAL-ER 162 mg achieved significant itch reduction vs 40% (8/20) receiving placebo (P=.03). At least a 50% reduction in WI-NRS was achieved by 33.3% (6/18) of patients receiving NAL-ER 162 mg twice daily. Extended open-label treatment was associated with further improvements in itch and lesion activity. Adverse events were mostly mild to moderate (eg, nausea, dizziness, headache, and fatigue) and occurred during dose titration. Physiologic opioid withdrawal symptoms were limited and resolved within a few days of discontinuing the medication.¹¹

Final Thoughts

In conclusion, PN remains one of the most challenging chronic dermatologic conditions to manage and is driven by a complex interplay of neuroimmune mechanisms and resistance to many conventional therapies. The approval of dupilumab and nemolizumab has marked a pivotal shift in the therapeutic landscape, offering hope to patients who previously had limited options^5,8; however, the burden of PN remains substantial, and many patients continue to experience relentless itch, poor sleep, and reduced quality of life.¹ Emerging therapies such as TRPM8 agonists, Janus kinase inhibitors, and opioid modulators represent promising additions to the treatment options, targeting novel pathways beyond traditional immunosuppression.^9-11

Prurigo nodularis (PN) is a chronic, severely pruritic neuroimmunologic skin disorder characterized by multiple firm hyperkeratotic nodules and intense pruritus, often leading to considerable impairment in quality of life and increased rates of depression and anxiety.¹ It is considered difficult to treat due to its complex pathogenesis, the severity and chronicity of pruritus, and the limited efficacy of conventional therapies.^2,3 The disease is driven by a self-perpetuating itch-scratch cycle, underpinned by dysregulation of both immune and neural pathways including type 2 (interleukin [IL] 4, IL-13, IL-31), Th17, and Th22 cytokines as well as neuropeptides and altered cutaneous nerve architecture.^1,3 This results in persistent severe pruritus and nodular lesions that are highly refractory to standard treatments.¹ Conventional therapies (eg, locally acting agents, phototherapy, and systemic immunomodulators and neuromodulators) have varied efficacy and notable adverse effect profiles.³ While the approval of targeted biologics has transformed the therapeutic landscape, several other treatment options also are being explored in clinical trials. Herein, we review all recently approved therapies as well as emerging treatments currently under investigation.

Dupilumab

Dupilumab, the first therapy for PN approved by the US Food and Drug Administration (FDA) in 2022—is a monoclonal antibody that inhibits signaling of IL-4 and IL-13, key drivers of type 2 inflammation implicated in PN pathogenesis.^4,5 In 2 pivotal phase 3 randomized controlled trials (LIBERTY-PN PRIME and PRIME2),⁵ dupilumab demonstrated notable efficacy in adults with moderate to severe PN. A reduction of 4 points or more on the Worst Itch Numeric Rating Scale (WI-NRS) was achieved by 60.0% (45/75) of patients treated with dupilumab at week 24 compared with 18.4% (14/76) receiving placebo in the PRIME trial. In PRIME2, the same outcome was achieved by 37.2% (29/78) of patients receiving dupilumab at week 12 compared with 22.0% (18/82) of patients receiving placebo.⁵ Dupilumab also led to a greater proportion of patients achieving a substantial reduction in nodule count (≤5 nodules) and improved quality of life compared with placebo.^5,6 The safety profile of dupilumab for treatment of PN was favorable and consistent with prior experience in atopic dermatitis; conjunctivitis was the most common adverse event.^5,6

Nemolizumab

Nemolizumab, an IL-31 receptor A antagonist, is the most recent agent approved by the FDA for PN in 2024.⁷ In the OLYMPIA 1 and OLYMPIA 2 phase 3 trials,⁸ nemolizumab produced a clinically meaningful reduction in itch (defined as a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score) in 56.3% (103/183) of patients at week 16 compared with 20.9% (19/91) receiving placebo. Additionally, 37.7% (69/183) of patients receiving nemolizumab achieved clear or almost clear skin (Investigator’s Global Assessment score of 0 or 1 with a ≥2-point reduction) vs 11.0% with placebo (both P<.001). Benefits were observed as early as week 4, including rapid improvements in itch, sleep disturbance, and nodule count.⁸ Nemolizumab also improved quality of life and reduced symptoms of anxiety and depression. The safety profile was favorable, with headache and atopic dermatitis the most common adverse events; serious adverse events were infrequent and similar between groups.⁸

Abrocitinib

Abrocitinib, an oral selective Janus kinase 1 inhibitor, is an investigational therapy for PN and currently has not been approved by the FDA for this indication. In a phase 2 open-label trial, abrocitinib 200 mg daily for 12 weeks led to a 78.3% reduction in weekly Peak Pruritus Numerical Rating Scale scores in PN, with 80.0% (8/10) of patients achieving a clinically meaningful improvement of 4 points or higher. Nodule counts and quality of life also improved, with an onset of itch relief as early as week 2. The safety profile was favorable, with acneform eruptions the most common adverse event and no serious adverse events reported⁹; however, these results are based on small, nonrandomized studies and require confirmation in larger randomized controlled trials before abrocitinib can be considered a standard therapy for PN.

Cryosim-1

Transient receptor potential melastatin 8 (TRPM8) is a cold-sensing ion channel found in unmyelinated sensory neurons within the dorsal root and trigeminal ­ganglia.¹⁰ It is activated by cool temperatures (15-28 °C) and compounds such as menthol, leading to calcium influx and a cooling sensation. In a randomized, double-blind, vehicle-controlled trial, researchers investigated the efficacy of cryosim-1 (a synthetic TRPM8 agonist) in treating PN.¹⁰ Thirty patients were enrolled, with 18 (60.0%) receiving cryosim-1 and 12 (40.0%) receiving placebo over 8 weeks. By week 8, cryosim-1 significantly reduced itch severity (mean numerical rating scale score postapplication, 2.8 vs 4.3; P=.031) and improved sleep disturbances (2.2 vs 4.2; P=.031) compared to placebo. Patients reported higher satisfaction with itch relief, and no adverse effects were observed. The study concluded that cryosim-1 is a safe, effective topical therapy for PN, likely working by interrupting the itch-scratch cycle and potentially modulating inflammatory pathways involved in chronic itch.¹⁰

Nalbuphine

Nalbuphine is a κ opioid receptor agonist and μ opioid receptor antagonist that has been investigated for the treatment of PN.¹¹ In a phase 2 randomized controlled trial, oral nalbuphine extended release (NAL-ER) 162 mg twice daily provided measurable antipruritic efficacy, with 44.4% (8/18) of patients achieving at least a 30% reduction in 7-day WI-NRS at week 10 compared with 36.4% (8/22) in the placebo group. Among those who completed the study, 66.7% (8/12) of patients receiving NAL-ER 162 mg achieved significant itch reduction vs 40% (8/20) receiving placebo (P=.03). At least a 50% reduction in WI-NRS was achieved by 33.3% (6/18) of patients receiving NAL-ER 162 mg twice daily. Extended open-label treatment was associated with further improvements in itch and lesion activity. Adverse events were mostly mild to moderate (eg, nausea, dizziness, headache, and fatigue) and occurred during dose titration. Physiologic opioid withdrawal symptoms were limited and resolved within a few days of discontinuing the medication.¹¹

Final Thoughts

In conclusion, PN remains one of the most challenging chronic dermatologic conditions to manage and is driven by a complex interplay of neuroimmune mechanisms and resistance to many conventional therapies. The approval of dupilumab and nemolizumab has marked a pivotal shift in the therapeutic landscape, offering hope to patients who previously had limited options^5,8; however, the burden of PN remains substantial, and many patients continue to experience relentless itch, poor sleep, and reduced quality of life.¹ Emerging therapies such as TRPM8 agonists, Janus kinase inhibitors, and opioid modulators represent promising additions to the treatment options, targeting novel pathways beyond traditional immunosuppression.^9-11

This transcript has been edited for clarity.

Hi, I’m Doctor Monty Pal, and I’m a medical oncologist at City of Hope Comprehensive Cancer Center.

I run the kidney cancer program there, and it’s really been amazing to see the tidal wave of new therapies that we’ve developed for kidney cancer over the years.

What I will say is that most of the treatments that we have, the doublet therapies and adjuvant treatments, really pertain to the most dominant subset of kidney cancer, and that’s clear cell; that really represents about 75%-80% of all cases of kidney cancer.

Having said that, I’d like to focus on perhaps a less dominant subset of kidney cancer known as papillary. This represents about 15%-20% of cases.

To be fair, there are other rare subtypes and those certainly warrant focus as well: Chromophobe represents about 5% of all diseases; translocation, unclassified, a percentage point or 2.

But papillary really is a setting in which we can do — and as I’ll demonstrate, have done — clinical trials.

Now papillary kidney cancer is similar in terms of its demographics to clear cell renal cell carcinoma (RCC). There still tends to be a male predominance. It may have a slightly lower age of initial presentation, but otherwise there’s many commonalities.

I do think one of the areas where it differs, and this is critical, is in the context of biology: We think that papillary RCC is really driven by the MET proto-oncogene amongst other things. With that in mind, there have been a whole host of therapies directed at the MET proto-oncogene, and we’ll discuss that in just a moment.

I wanted to first talk about management of localized papillary kidney cancer. This management doesn’t differ significantly from what we would perhaps consider in the context of localized clear cell kidney cancer. For stage 1 through 3 disease, patients still receive surgery as the mainstay, and I would argue that, in the context of stage 4 disease, we should still really consider aggressive local definitive therapies if at all possible.

Having said that, the role of adjuvant therapy is a bit unclear in this context. I would suggest that in the context of adjuvant therapy for papillary kidney cancer, it’s a bit of a no go until we have greater data in this setting. Therapies like pembrolizumab and sunitinib really were only tested in the context of clear cell disease.

And with that background, I wanted to move into metastatic disease. For patients with stage 4 papillary kidney cancer, therapy may or may not resemble the treatments that we use for clear cell kidney cancer.

There have been trials in yesteryear with really creative names, ASPEN and ESPN for instance, that actually juxtaposed older therapies against one another. Sunitinib against everolimus, for instance, was common to both of those studies. And it really suggested perhaps that sunitinib was the preferred choice between those two targeted therapies. Sunitinib then became a bit of a standard when it came to randomized trials, and in fact, it still remains something that’s incorporated as a base regimen at phase 3 clinical trials.

I’ll show you that in the PAPMET clinical trial, which was a randomized phase 2 experience, we were able to compare sunitinib to cabozantinib, crizotinib, and savolitinib. The latter three drugs are all so-called MET inhibitors. And what’s quite interesting about this study is that cabozantinib, the dual VEGF/MET inhibitor, really is the one that seemed to win out.

When you look at median progression-free survival (PFS), in sunitinib in that study was around 6 months. When you look at cabozantinib, it was around 9 months.

Having said that, with cabozantinib, there was no overall survival advantage, and I will say that the PFS benefit is modest. So, we still need more in the way of clinical trials.

To that end, there’s a number of single arm studies supporting cabozantinib-based regimens, cabozantinib/atezolizumab and cabozantinib/nivolumab, with healthy response rates. For papillary kidney cancer, the response rate with those regimens is around 43%-47%.

In the context of lenvatinib and pembrolizumab, we actually see the response rate augmented to approximately 53%.

So, with those numbers in mind, I definitely think that doublet therapy is promising, but as we always tell our fellows in the clinic, randomization is really king.

So, we do have two phase 3 clinical trials, STELLAR-304, which is a study that I’m running, and the second study is known as SAMETA. Both evaluate papillary patients, but in very different ways.

STELLAR-304 includes patients with papillary, translocation, and unclassified kidney cancer and randomizes to sunitinib vs zanzalintinib, a novel TKI, with nivolumab.

In contrast, SAMETA takes the very interesting approach of actually selecting out patients with MET abnormalities and randomizing them to sunitinib vs savolitinib.

There are other approaches. For instance, the SUNNIFORECAST study recently assessed nivolumab and ipilimumab. There are randomized phase 2 studies looking at axitinib and pembrolizumab or perhaps axitinib and, sorry, cabozantinib with atezolizumab.

But I do think these phase 3 studies, SAMETA and STELLAR-304, are the ones that are really poised to change the landscape of therapy for papillary kidney cancer.

Sumanta K. Pal, MD, Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, California, has disclosed the following relevant financial relationships: Received travel from: CRISPR; Ipsen. A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi, I’m Doctor Monty Pal, and I’m a medical oncologist at City of Hope Comprehensive Cancer Center.

I run the kidney cancer program there, and it’s really been amazing to see the tidal wave of new therapies that we’ve developed for kidney cancer over the years.

What I will say is that most of the treatments that we have, the doublet therapies and adjuvant treatments, really pertain to the most dominant subset of kidney cancer, and that’s clear cell; that really represents about 75%-80% of all cases of kidney cancer.

Having said that, I’d like to focus on perhaps a less dominant subset of kidney cancer known as papillary. This represents about 15%-20% of cases.

To be fair, there are other rare subtypes and those certainly warrant focus as well: Chromophobe represents about 5% of all diseases; translocation, unclassified, a percentage point or 2.

But papillary really is a setting in which we can do — and as I’ll demonstrate, have done — clinical trials.

Now papillary kidney cancer is similar in terms of its demographics to clear cell renal cell carcinoma (RCC). There still tends to be a male predominance. It may have a slightly lower age of initial presentation, but otherwise there’s many commonalities.

I do think one of the areas where it differs, and this is critical, is in the context of biology: We think that papillary RCC is really driven by the MET proto-oncogene amongst other things. With that in mind, there have been a whole host of therapies directed at the MET proto-oncogene, and we’ll discuss that in just a moment.

I wanted to first talk about management of localized papillary kidney cancer. This management doesn’t differ significantly from what we would perhaps consider in the context of localized clear cell kidney cancer. For stage 1 through 3 disease, patients still receive surgery as the mainstay, and I would argue that, in the context of stage 4 disease, we should still really consider aggressive local definitive therapies if at all possible.

Having said that, the role of adjuvant therapy is a bit unclear in this context. I would suggest that in the context of adjuvant therapy for papillary kidney cancer, it’s a bit of a no go until we have greater data in this setting. Therapies like pembrolizumab and sunitinib really were only tested in the context of clear cell disease.

And with that background, I wanted to move into metastatic disease. For patients with stage 4 papillary kidney cancer, therapy may or may not resemble the treatments that we use for clear cell kidney cancer.

There have been trials in yesteryear with really creative names, ASPEN and ESPN for instance, that actually juxtaposed older therapies against one another. Sunitinib against everolimus, for instance, was common to both of those studies. And it really suggested perhaps that sunitinib was the preferred choice between those two targeted therapies. Sunitinib then became a bit of a standard when it came to randomized trials, and in fact, it still remains something that’s incorporated as a base regimen at phase 3 clinical trials.

I’ll show you that in the PAPMET clinical trial, which was a randomized phase 2 experience, we were able to compare sunitinib to cabozantinib, crizotinib, and savolitinib. The latter three drugs are all so-called MET inhibitors. And what’s quite interesting about this study is that cabozantinib, the dual VEGF/MET inhibitor, really is the one that seemed to win out.

When you look at median progression-free survival (PFS), in sunitinib in that study was around 6 months. When you look at cabozantinib, it was around 9 months.

Having said that, with cabozantinib, there was no overall survival advantage, and I will say that the PFS benefit is modest. So, we still need more in the way of clinical trials.

To that end, there’s a number of single arm studies supporting cabozantinib-based regimens, cabozantinib/atezolizumab and cabozantinib/nivolumab, with healthy response rates. For papillary kidney cancer, the response rate with those regimens is around 43%-47%.

In the context of lenvatinib and pembrolizumab, we actually see the response rate augmented to approximately 53%.

So, with those numbers in mind, I definitely think that doublet therapy is promising, but as we always tell our fellows in the clinic, randomization is really king.

So, we do have two phase 3 clinical trials, STELLAR-304, which is a study that I’m running, and the second study is known as SAMETA. Both evaluate papillary patients, but in very different ways.

STELLAR-304 includes patients with papillary, translocation, and unclassified kidney cancer and randomizes to sunitinib vs zanzalintinib, a novel TKI, with nivolumab.

In contrast, SAMETA takes the very interesting approach of actually selecting out patients with MET abnormalities and randomizing them to sunitinib vs savolitinib.

There are other approaches. For instance, the SUNNIFORECAST study recently assessed nivolumab and ipilimumab. There are randomized phase 2 studies looking at axitinib and pembrolizumab or perhaps axitinib and, sorry, cabozantinib with atezolizumab.

But I do think these phase 3 studies, SAMETA and STELLAR-304, are the ones that are really poised to change the landscape of therapy for papillary kidney cancer.

Sumanta K. Pal, MD, Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, California, has disclosed the following relevant financial relationships: Received travel from: CRISPR; Ipsen. A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi, I’m Doctor Monty Pal, and I’m a medical oncologist at City of Hope Comprehensive Cancer Center.

I run the kidney cancer program there, and it’s really been amazing to see the tidal wave of new therapies that we’ve developed for kidney cancer over the years.

What I will say is that most of the treatments that we have, the doublet therapies and adjuvant treatments, really pertain to the most dominant subset of kidney cancer, and that’s clear cell; that really represents about 75%-80% of all cases of kidney cancer.

Having said that, I’d like to focus on perhaps a less dominant subset of kidney cancer known as papillary. This represents about 15%-20% of cases.

To be fair, there are other rare subtypes and those certainly warrant focus as well: Chromophobe represents about 5% of all diseases; translocation, unclassified, a percentage point or 2.

But papillary really is a setting in which we can do — and as I’ll demonstrate, have done — clinical trials.

Now papillary kidney cancer is similar in terms of its demographics to clear cell renal cell carcinoma (RCC). There still tends to be a male predominance. It may have a slightly lower age of initial presentation, but otherwise there’s many commonalities.

I do think one of the areas where it differs, and this is critical, is in the context of biology: We think that papillary RCC is really driven by the MET proto-oncogene amongst other things. With that in mind, there have been a whole host of therapies directed at the MET proto-oncogene, and we’ll discuss that in just a moment.

I wanted to first talk about management of localized papillary kidney cancer. This management doesn’t differ significantly from what we would perhaps consider in the context of localized clear cell kidney cancer. For stage 1 through 3 disease, patients still receive surgery as the mainstay, and I would argue that, in the context of stage 4 disease, we should still really consider aggressive local definitive therapies if at all possible.

Having said that, the role of adjuvant therapy is a bit unclear in this context. I would suggest that in the context of adjuvant therapy for papillary kidney cancer, it’s a bit of a no go until we have greater data in this setting. Therapies like pembrolizumab and sunitinib really were only tested in the context of clear cell disease.

And with that background, I wanted to move into metastatic disease. For patients with stage 4 papillary kidney cancer, therapy may or may not resemble the treatments that we use for clear cell kidney cancer.

There have been trials in yesteryear with really creative names, ASPEN and ESPN for instance, that actually juxtaposed older therapies against one another. Sunitinib against everolimus, for instance, was common to both of those studies. And it really suggested perhaps that sunitinib was the preferred choice between those two targeted therapies. Sunitinib then became a bit of a standard when it came to randomized trials, and in fact, it still remains something that’s incorporated as a base regimen at phase 3 clinical trials.

I’ll show you that in the PAPMET clinical trial, which was a randomized phase 2 experience, we were able to compare sunitinib to cabozantinib, crizotinib, and savolitinib. The latter three drugs are all so-called MET inhibitors. And what’s quite interesting about this study is that cabozantinib, the dual VEGF/MET inhibitor, really is the one that seemed to win out.

When you look at median progression-free survival (PFS), in sunitinib in that study was around 6 months. When you look at cabozantinib, it was around 9 months.

Having said that, with cabozantinib, there was no overall survival advantage, and I will say that the PFS benefit is modest. So, we still need more in the way of clinical trials.

To that end, there’s a number of single arm studies supporting cabozantinib-based regimens, cabozantinib/atezolizumab and cabozantinib/nivolumab, with healthy response rates. For papillary kidney cancer, the response rate with those regimens is around 43%-47%.

In the context of lenvatinib and pembrolizumab, we actually see the response rate augmented to approximately 53%.

So, with those numbers in mind, I definitely think that doublet therapy is promising, but as we always tell our fellows in the clinic, randomization is really king.

So, we do have two phase 3 clinical trials, STELLAR-304, which is a study that I’m running, and the second study is known as SAMETA. Both evaluate papillary patients, but in very different ways.

STELLAR-304 includes patients with papillary, translocation, and unclassified kidney cancer and randomizes to sunitinib vs zanzalintinib, a novel TKI, with nivolumab.

In contrast, SAMETA takes the very interesting approach of actually selecting out patients with MET abnormalities and randomizing them to sunitinib vs savolitinib.

There are other approaches. For instance, the SUNNIFORECAST study recently assessed nivolumab and ipilimumab. There are randomized phase 2 studies looking at axitinib and pembrolizumab or perhaps axitinib and, sorry, cabozantinib with atezolizumab.

But I do think these phase 3 studies, SAMETA and STELLAR-304, are the ones that are really poised to change the landscape of therapy for papillary kidney cancer.

Sumanta K. Pal, MD, Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, California, has disclosed the following relevant financial relationships: Received travel from: CRISPR; Ipsen. A version of this article appeared on Medscape.com.