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AI Algorithm Predicts Transfusion Need, Mortality Risk in Acute GI Bleeds
SAN DIEGO — , researchers reported at Digestive Disease Week® (DDW) 2025.
Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.
However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.
“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.
As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.
The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.
Defining the AI Framework
“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”
Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”
The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.
Study Details
The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.
Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.
The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.
The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.
The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.
Expert Perspective
“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.
“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”
Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”
“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”
“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.
The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.
Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.
A version of this article appeared on Medscape.com.
SAN DIEGO — , researchers reported at Digestive Disease Week® (DDW) 2025.
Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.
However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.
“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.
As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.
The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.
Defining the AI Framework
“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”
Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”
The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.
Study Details
The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.
Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.
The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.
The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.
The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.
Expert Perspective
“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.
“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”
Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”
“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”
“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.
The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.
Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.
A version of this article appeared on Medscape.com.
SAN DIEGO — , researchers reported at Digestive Disease Week® (DDW) 2025.
Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.
However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.
“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.
As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.
The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.
Defining the AI Framework
“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”
Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”
The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.
Study Details
The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.
Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.
The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.
The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.
The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.
Expert Perspective
“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.
“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”
Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”
“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”
“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.
The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.
Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Blood-Based Test May Predict Crohn’s Disease 2 Years Before Onset
SAN DIEGO — Crohn’s disease (CD) has become more common in the United States, and an estimated 1 million Americans have the condition. Still, much is unknown about how to evaluate the individual risk for the disease.
“It’s pretty much accepted that Crohn’s disease does not begin at diagnosis,” said Ryan Ungaro, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, speaking at Digestive Disease Week (DDW)® 2025.
Although individual blood markers have been associated with the future risk for CD, what’s needed, he said, is to understand which combination of biomarkers are most predictive.
Now, .
It’s an early version that will likely be further improved and needs additional validation, Ungaro told GI & Hepatology News.
“Once we can accurately identify individuals at risk for developing Crohn’s disease, we can then imagine a number of potential interventions,” Ungaro said.
Approaches would vary depending on how far away the onset is estimated to be. For people who likely wouldn’t develop disease for many years, one intervention might be close monitoring to enable diagnosis in the earliest stages, when treatment works best, he said. Someone at a high risk of developing CD in the next 2 or 3 years, on the other hand, might be offered a pharmaceutical intervention.
Developing and Testing the Risk Score
To develop the risk score, Ungaro and colleagues analyzed data of 200 patients with CD and 100 healthy control participants from PREDICTS, a nested case-controlled study of active US military service members. The study is within the larger Department of Defense Serum Repository, which began in 1985 and has more than 62.5 million samples, all stored at −30 °C.
The researchers collected serum samples at four timepoints up to 6 or more years before the diagnosis. They assayed antimicrobial antibodies using the Prometheus Laboratories platform, proteomic markers using the Olink inflammation panel, and anti–granulocyte macrophage colony-stimulating factor autoantibodies using enzyme-linked immunosorbent assay.
Participants (median age, 33 years for both groups) were randomly divided into equally sized training and testing sets. In both the group, 83% of patients were White and about 90% were men.
Time-varying trajectories of marker abundance were estimated for each biomarker. Then, logistic regression modeled disease status as a function of each marker for different timepoints and multivariate modeling was performed via logistic LASSO regression.
A risk score to predict CD onset within 2 years was developed. Prediction models were fit on the testing set and predictive performance evaluated using receiver operating characteristic curves and area under the curve (AUC).
Blood proteins and antibodies have differing associations with CD depending on the time before diagnosis, the researchers found.
The integrative model to predict CD onset within 2 years incorporated 10 biomarkers associated significantly with CD onset.
The AUC for the model was 0.87 (considered good, with 1 indicating perfect discrimination). It produced a specificity of 99% and a positive predictive value of 84%.
The researchers stratified the model scores into quartiles and found the CD incidence within 2 years increased from 2% in the first quartile to 57.7% in the fourth. The relative risk of developing CD in the top quartile individuals vs lower quartile individuals was 10.4.
The serologic and proteomic markers show dynamic changes years before the diagnosis, Ungaro said.
A Strong Start
The research represents “an ambitious and exciting frontier for the future of IBD [inflammatory bowel disease] care,” said Victor G. Chedid, MD, MS, consultant and assistant professor of medicine at Mayo Clinic, Rochester, Minnesota, who reviewed the findings but was not involved in the study.
Currently, physicians treat IBD once it manifests, and it’s difficult to predict who will get CD, he said.
The integrative model’s AUC of 0.87 is impressive, and its specificity and positive predictive value levels show it is highly accurate in predicting the onset of CD within 2 years, Chedid added.
Further validation in larger and more diverse population is needed, Chedid said, but he sees the potential for the model to be practical in clinical practice.
“Additionally, the use of blood-based biomarkers makes the model relatively noninvasive and easy to implement in a clinical setting,” he said.
Now, the research goal is to understand the best biomarkers for characterizing the different preclinical phases of CD and to test different interventions in prevention trials, Ungaro told GI & Hepatology News.
A few trials are planned or ongoing, he noted. The trial PIONIR trial will look at the impact of a specific diet on the risk of developing CD, and the INTERCEPT trial aims to develop a blood-based risk score that can identify individuals with a high risk of developing CD within 5 years after initial evaluation.
Ungaro reported being on the advisory board of and/or receiving speaker or consulting fees from AbbVie, Bristol Myer Squibb, Celltrion, ECM Therapeutics, Genentech, Jansen, Eli Lilly, Pfizer, Roivant, Sanofi, and Takeda. Chedid reported having no relevant disclosures.
The PROMISE Consortium is funded by the Helmsley Charitable Trust.
A version of this article appeared on Medscape.com.
SAN DIEGO — Crohn’s disease (CD) has become more common in the United States, and an estimated 1 million Americans have the condition. Still, much is unknown about how to evaluate the individual risk for the disease.
“It’s pretty much accepted that Crohn’s disease does not begin at diagnosis,” said Ryan Ungaro, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, speaking at Digestive Disease Week (DDW)® 2025.
Although individual blood markers have been associated with the future risk for CD, what’s needed, he said, is to understand which combination of biomarkers are most predictive.
Now, .
It’s an early version that will likely be further improved and needs additional validation, Ungaro told GI & Hepatology News.
“Once we can accurately identify individuals at risk for developing Crohn’s disease, we can then imagine a number of potential interventions,” Ungaro said.
Approaches would vary depending on how far away the onset is estimated to be. For people who likely wouldn’t develop disease for many years, one intervention might be close monitoring to enable diagnosis in the earliest stages, when treatment works best, he said. Someone at a high risk of developing CD in the next 2 or 3 years, on the other hand, might be offered a pharmaceutical intervention.
Developing and Testing the Risk Score
To develop the risk score, Ungaro and colleagues analyzed data of 200 patients with CD and 100 healthy control participants from PREDICTS, a nested case-controlled study of active US military service members. The study is within the larger Department of Defense Serum Repository, which began in 1985 and has more than 62.5 million samples, all stored at −30 °C.
The researchers collected serum samples at four timepoints up to 6 or more years before the diagnosis. They assayed antimicrobial antibodies using the Prometheus Laboratories platform, proteomic markers using the Olink inflammation panel, and anti–granulocyte macrophage colony-stimulating factor autoantibodies using enzyme-linked immunosorbent assay.
Participants (median age, 33 years for both groups) were randomly divided into equally sized training and testing sets. In both the group, 83% of patients were White and about 90% were men.
Time-varying trajectories of marker abundance were estimated for each biomarker. Then, logistic regression modeled disease status as a function of each marker for different timepoints and multivariate modeling was performed via logistic LASSO regression.
A risk score to predict CD onset within 2 years was developed. Prediction models were fit on the testing set and predictive performance evaluated using receiver operating characteristic curves and area under the curve (AUC).
Blood proteins and antibodies have differing associations with CD depending on the time before diagnosis, the researchers found.
The integrative model to predict CD onset within 2 years incorporated 10 biomarkers associated significantly with CD onset.
The AUC for the model was 0.87 (considered good, with 1 indicating perfect discrimination). It produced a specificity of 99% and a positive predictive value of 84%.
The researchers stratified the model scores into quartiles and found the CD incidence within 2 years increased from 2% in the first quartile to 57.7% in the fourth. The relative risk of developing CD in the top quartile individuals vs lower quartile individuals was 10.4.
The serologic and proteomic markers show dynamic changes years before the diagnosis, Ungaro said.
A Strong Start
The research represents “an ambitious and exciting frontier for the future of IBD [inflammatory bowel disease] care,” said Victor G. Chedid, MD, MS, consultant and assistant professor of medicine at Mayo Clinic, Rochester, Minnesota, who reviewed the findings but was not involved in the study.
Currently, physicians treat IBD once it manifests, and it’s difficult to predict who will get CD, he said.
The integrative model’s AUC of 0.87 is impressive, and its specificity and positive predictive value levels show it is highly accurate in predicting the onset of CD within 2 years, Chedid added.
Further validation in larger and more diverse population is needed, Chedid said, but he sees the potential for the model to be practical in clinical practice.
“Additionally, the use of blood-based biomarkers makes the model relatively noninvasive and easy to implement in a clinical setting,” he said.
Now, the research goal is to understand the best biomarkers for characterizing the different preclinical phases of CD and to test different interventions in prevention trials, Ungaro told GI & Hepatology News.
A few trials are planned or ongoing, he noted. The trial PIONIR trial will look at the impact of a specific diet on the risk of developing CD, and the INTERCEPT trial aims to develop a blood-based risk score that can identify individuals with a high risk of developing CD within 5 years after initial evaluation.
Ungaro reported being on the advisory board of and/or receiving speaker or consulting fees from AbbVie, Bristol Myer Squibb, Celltrion, ECM Therapeutics, Genentech, Jansen, Eli Lilly, Pfizer, Roivant, Sanofi, and Takeda. Chedid reported having no relevant disclosures.
The PROMISE Consortium is funded by the Helmsley Charitable Trust.
A version of this article appeared on Medscape.com.
SAN DIEGO — Crohn’s disease (CD) has become more common in the United States, and an estimated 1 million Americans have the condition. Still, much is unknown about how to evaluate the individual risk for the disease.
“It’s pretty much accepted that Crohn’s disease does not begin at diagnosis,” said Ryan Ungaro, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, speaking at Digestive Disease Week (DDW)® 2025.
Although individual blood markers have been associated with the future risk for CD, what’s needed, he said, is to understand which combination of biomarkers are most predictive.
Now, .
It’s an early version that will likely be further improved and needs additional validation, Ungaro told GI & Hepatology News.
“Once we can accurately identify individuals at risk for developing Crohn’s disease, we can then imagine a number of potential interventions,” Ungaro said.
Approaches would vary depending on how far away the onset is estimated to be. For people who likely wouldn’t develop disease for many years, one intervention might be close monitoring to enable diagnosis in the earliest stages, when treatment works best, he said. Someone at a high risk of developing CD in the next 2 or 3 years, on the other hand, might be offered a pharmaceutical intervention.
Developing and Testing the Risk Score
To develop the risk score, Ungaro and colleagues analyzed data of 200 patients with CD and 100 healthy control participants from PREDICTS, a nested case-controlled study of active US military service members. The study is within the larger Department of Defense Serum Repository, which began in 1985 and has more than 62.5 million samples, all stored at −30 °C.
The researchers collected serum samples at four timepoints up to 6 or more years before the diagnosis. They assayed antimicrobial antibodies using the Prometheus Laboratories platform, proteomic markers using the Olink inflammation panel, and anti–granulocyte macrophage colony-stimulating factor autoantibodies using enzyme-linked immunosorbent assay.
Participants (median age, 33 years for both groups) were randomly divided into equally sized training and testing sets. In both the group, 83% of patients were White and about 90% were men.
Time-varying trajectories of marker abundance were estimated for each biomarker. Then, logistic regression modeled disease status as a function of each marker for different timepoints and multivariate modeling was performed via logistic LASSO regression.
A risk score to predict CD onset within 2 years was developed. Prediction models were fit on the testing set and predictive performance evaluated using receiver operating characteristic curves and area under the curve (AUC).
Blood proteins and antibodies have differing associations with CD depending on the time before diagnosis, the researchers found.
The integrative model to predict CD onset within 2 years incorporated 10 biomarkers associated significantly with CD onset.
The AUC for the model was 0.87 (considered good, with 1 indicating perfect discrimination). It produced a specificity of 99% and a positive predictive value of 84%.
The researchers stratified the model scores into quartiles and found the CD incidence within 2 years increased from 2% in the first quartile to 57.7% in the fourth. The relative risk of developing CD in the top quartile individuals vs lower quartile individuals was 10.4.
The serologic and proteomic markers show dynamic changes years before the diagnosis, Ungaro said.
A Strong Start
The research represents “an ambitious and exciting frontier for the future of IBD [inflammatory bowel disease] care,” said Victor G. Chedid, MD, MS, consultant and assistant professor of medicine at Mayo Clinic, Rochester, Minnesota, who reviewed the findings but was not involved in the study.
Currently, physicians treat IBD once it manifests, and it’s difficult to predict who will get CD, he said.
The integrative model’s AUC of 0.87 is impressive, and its specificity and positive predictive value levels show it is highly accurate in predicting the onset of CD within 2 years, Chedid added.
Further validation in larger and more diverse population is needed, Chedid said, but he sees the potential for the model to be practical in clinical practice.
“Additionally, the use of blood-based biomarkers makes the model relatively noninvasive and easy to implement in a clinical setting,” he said.
Now, the research goal is to understand the best biomarkers for characterizing the different preclinical phases of CD and to test different interventions in prevention trials, Ungaro told GI & Hepatology News.
A few trials are planned or ongoing, he noted. The trial PIONIR trial will look at the impact of a specific diet on the risk of developing CD, and the INTERCEPT trial aims to develop a blood-based risk score that can identify individuals with a high risk of developing CD within 5 years after initial evaluation.
Ungaro reported being on the advisory board of and/or receiving speaker or consulting fees from AbbVie, Bristol Myer Squibb, Celltrion, ECM Therapeutics, Genentech, Jansen, Eli Lilly, Pfizer, Roivant, Sanofi, and Takeda. Chedid reported having no relevant disclosures.
The PROMISE Consortium is funded by the Helmsley Charitable Trust.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Winning Strategies to Retain Private Practice Gastroenterologists
SAN DIEGO — With the recently updated recommendations by the US Preventive Services Task Force lowering the age for colorectal cancer screening to 45 instead of 50, an additional 19 million patients now require screening, Asma Khapra, MD, AGAF, a gastroenterologist at Gastro Health in Fairfax, Virginia, told attendees at Digestive Disease Week® (DDW) 2025.
That change, coupled with the expected shortage of gastroenterologists, means one thing: The current workforce can’t meet patient demand, she said. , Khapra added.
The private practice model is already declining, she said. The fraction of US gastroenterologists in “fully independent” private practice was about 30% in 2019, Khapra noted. Then, “COVID really changed the landscape even more.” By 2022, “that number has shrunk to 13%.” Meanwhile, 67% are employed gastroenterologists (not in private practice), 7% work in large group practices, and 13% are private equity (PE) backed.
That makes effective retention strategies crucial for private practices, Khapra said. She first addressed the common attractions of private practices, then the challenges, and finally the winning strategies to retain and keep a viable private practice gastroenterology workforce.
The Attractions of Private Practice
The reasons for choosing private practice are many, Khapra said, including:
- Autonomy,
- Flexibility,
- Competitive compensation,
- Ownership mindset,
- Partnership paths, and
- Work-life balance including involvement in community and culture.
On the other hand, private practices have unique challenges, including:
- Administrative burdens such as EHR documentation, paperwork, prior authorizations, and staffing issues,
- Financial pressures, including competition with the employment packages offered by hospitals, as reimbursements continue to drop and staffing costs increase,
- Burnout,
- Variety of buy-ins and partnership tracks,
- Limited career development, and
- The strains of aging and endoscopy. “We used to joke in our practice that at any given time, three staff members are in physical therapy due to injuries and disabilities.”
Employing the Iceberg Model
One strategy, Khapra said, is to follow Edward T. Hall’s Iceberg Model of Culture , which focuses on the importance of both visible and invisible elements.
“The key to retention in private practice is to develop a value system where everyone is treated well and respected and compensated fairly,” she said. “That doesn’t mean you split the pie [equally].”
“Visible” elements of the model include the physical environment, policies and practices, symbols and behaviors, she said. While under the surface (“invisible” elements) are shared values, perceptions and attitudes, leadership style, conflict resolution, decision making and unwritten rules.
The key, she said, is to provide physicians an actual voice in decision making and to avoid favouritism, thus avoiding comments such as “Why do the same two people always get the prime scoping blocks?”
Financial transparency is also important, Khapra said. And people want flexibility without it being called special treatment. She provided several practical suggestions to accomplish the invisible Iceberg goals.
For instance, she suggested paying for activities outside the practice that physicians do, such as serving on committees. If the practice can’t afford that, she suggested asking the affiliated hospitals to do so, noting that such an initiative can often build community support.
Paying more attention to early associates than is typical can also benefit the practice, Khapra said. “So much effort is made to recruit them, and then once there, we’re on to the next [recruits].” Instead, she suggested, “pay attention to their needs.”
Providing support to physicians who are injured is also crucial and can foster a community culture, she said. For example, one Gastro Health physician was out for 4 weeks due to complications from surgery. “Everyone jumped in” to help fill the injured physician’s shifts, she said, reassuring the physician that the money would be figured out later. “That’s the culture you want to instill.”
To prevent burnout, another key to retaining physicians, “you have to provide support staff.” And offering good benefits, including parental and maternal leave and disability benefits, is also crucial, Khapra said. Consider practices such as having social dinners, another way to build a sense of community.
Finally, bring in national and local gastroenterologist organizations for discussions, including advocating for fair reimbursement for private practice. Consider working with the Digestive Health Physicians Alliance, which describes itself as the voice of independent gastroenterology, she suggested.
More Perspectives
Jami Kinnucan, MD, AGAF, a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville , Florida, spoke about optimizing recruitment of young gastroenterologists and provided perspective on Khapra’s talk.
“I think there’s a lot of overlap” with her topic and retaining private practice gastroenterologists, she said in an interview with GI & Hepatology News. Most important, she said, is having an efficient system in which the administrative flow is left to digital tools or other staff, not physicians. “That will also help to reduce burnout,” she said, and allow physicians to do what they most want to do, which is to focus on providing care to patients.
“People want to feel valued for their work,” she agreed. “People want opportunity for career development, opportunities for growth.”
As gastroenterologists age, flexibility is important, as it in in general for all physicians, Kinnucan said. She suggested schedule flexibility as one way. For instance, “if I tell 10 providers, ‘I need you to see 100 patients this week, but you can do it however you want,’ that promotes flexibility. They might want to see all of them on Monday and Tuesday, for instance. If you give people choice and autonomy, they are more likely to feel like they are part of the decision.”
How do you build a high-functioning team? “You do it by letting them operate autonomously,” and “you let people do the things they are really excited about.” And always, as Khapra said, focus on the invisible elements that are so crucial.
Khapra and Kinnucan had no relevant disclosures. Khapra received no funding for her presentation.
A version of this article appeared on Medscape.com.
SAN DIEGO — With the recently updated recommendations by the US Preventive Services Task Force lowering the age for colorectal cancer screening to 45 instead of 50, an additional 19 million patients now require screening, Asma Khapra, MD, AGAF, a gastroenterologist at Gastro Health in Fairfax, Virginia, told attendees at Digestive Disease Week® (DDW) 2025.
That change, coupled with the expected shortage of gastroenterologists, means one thing: The current workforce can’t meet patient demand, she said. , Khapra added.
The private practice model is already declining, she said. The fraction of US gastroenterologists in “fully independent” private practice was about 30% in 2019, Khapra noted. Then, “COVID really changed the landscape even more.” By 2022, “that number has shrunk to 13%.” Meanwhile, 67% are employed gastroenterologists (not in private practice), 7% work in large group practices, and 13% are private equity (PE) backed.
That makes effective retention strategies crucial for private practices, Khapra said. She first addressed the common attractions of private practices, then the challenges, and finally the winning strategies to retain and keep a viable private practice gastroenterology workforce.
The Attractions of Private Practice
The reasons for choosing private practice are many, Khapra said, including:
- Autonomy,
- Flexibility,
- Competitive compensation,
- Ownership mindset,
- Partnership paths, and
- Work-life balance including involvement in community and culture.
On the other hand, private practices have unique challenges, including:
- Administrative burdens such as EHR documentation, paperwork, prior authorizations, and staffing issues,
- Financial pressures, including competition with the employment packages offered by hospitals, as reimbursements continue to drop and staffing costs increase,
- Burnout,
- Variety of buy-ins and partnership tracks,
- Limited career development, and
- The strains of aging and endoscopy. “We used to joke in our practice that at any given time, three staff members are in physical therapy due to injuries and disabilities.”
Employing the Iceberg Model
One strategy, Khapra said, is to follow Edward T. Hall’s Iceberg Model of Culture , which focuses on the importance of both visible and invisible elements.
“The key to retention in private practice is to develop a value system where everyone is treated well and respected and compensated fairly,” she said. “That doesn’t mean you split the pie [equally].”
“Visible” elements of the model include the physical environment, policies and practices, symbols and behaviors, she said. While under the surface (“invisible” elements) are shared values, perceptions and attitudes, leadership style, conflict resolution, decision making and unwritten rules.
The key, she said, is to provide physicians an actual voice in decision making and to avoid favouritism, thus avoiding comments such as “Why do the same two people always get the prime scoping blocks?”
Financial transparency is also important, Khapra said. And people want flexibility without it being called special treatment. She provided several practical suggestions to accomplish the invisible Iceberg goals.
For instance, she suggested paying for activities outside the practice that physicians do, such as serving on committees. If the practice can’t afford that, she suggested asking the affiliated hospitals to do so, noting that such an initiative can often build community support.
Paying more attention to early associates than is typical can also benefit the practice, Khapra said. “So much effort is made to recruit them, and then once there, we’re on to the next [recruits].” Instead, she suggested, “pay attention to their needs.”
Providing support to physicians who are injured is also crucial and can foster a community culture, she said. For example, one Gastro Health physician was out for 4 weeks due to complications from surgery. “Everyone jumped in” to help fill the injured physician’s shifts, she said, reassuring the physician that the money would be figured out later. “That’s the culture you want to instill.”
To prevent burnout, another key to retaining physicians, “you have to provide support staff.” And offering good benefits, including parental and maternal leave and disability benefits, is also crucial, Khapra said. Consider practices such as having social dinners, another way to build a sense of community.
Finally, bring in national and local gastroenterologist organizations for discussions, including advocating for fair reimbursement for private practice. Consider working with the Digestive Health Physicians Alliance, which describes itself as the voice of independent gastroenterology, she suggested.
More Perspectives
Jami Kinnucan, MD, AGAF, a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville , Florida, spoke about optimizing recruitment of young gastroenterologists and provided perspective on Khapra’s talk.
“I think there’s a lot of overlap” with her topic and retaining private practice gastroenterologists, she said in an interview with GI & Hepatology News. Most important, she said, is having an efficient system in which the administrative flow is left to digital tools or other staff, not physicians. “That will also help to reduce burnout,” she said, and allow physicians to do what they most want to do, which is to focus on providing care to patients.
“People want to feel valued for their work,” she agreed. “People want opportunity for career development, opportunities for growth.”
As gastroenterologists age, flexibility is important, as it in in general for all physicians, Kinnucan said. She suggested schedule flexibility as one way. For instance, “if I tell 10 providers, ‘I need you to see 100 patients this week, but you can do it however you want,’ that promotes flexibility. They might want to see all of them on Monday and Tuesday, for instance. If you give people choice and autonomy, they are more likely to feel like they are part of the decision.”
How do you build a high-functioning team? “You do it by letting them operate autonomously,” and “you let people do the things they are really excited about.” And always, as Khapra said, focus on the invisible elements that are so crucial.
Khapra and Kinnucan had no relevant disclosures. Khapra received no funding for her presentation.
A version of this article appeared on Medscape.com.
SAN DIEGO — With the recently updated recommendations by the US Preventive Services Task Force lowering the age for colorectal cancer screening to 45 instead of 50, an additional 19 million patients now require screening, Asma Khapra, MD, AGAF, a gastroenterologist at Gastro Health in Fairfax, Virginia, told attendees at Digestive Disease Week® (DDW) 2025.
That change, coupled with the expected shortage of gastroenterologists, means one thing: The current workforce can’t meet patient demand, she said. , Khapra added.
The private practice model is already declining, she said. The fraction of US gastroenterologists in “fully independent” private practice was about 30% in 2019, Khapra noted. Then, “COVID really changed the landscape even more.” By 2022, “that number has shrunk to 13%.” Meanwhile, 67% are employed gastroenterologists (not in private practice), 7% work in large group practices, and 13% are private equity (PE) backed.
That makes effective retention strategies crucial for private practices, Khapra said. She first addressed the common attractions of private practices, then the challenges, and finally the winning strategies to retain and keep a viable private practice gastroenterology workforce.
The Attractions of Private Practice
The reasons for choosing private practice are many, Khapra said, including:
- Autonomy,
- Flexibility,
- Competitive compensation,
- Ownership mindset,
- Partnership paths, and
- Work-life balance including involvement in community and culture.
On the other hand, private practices have unique challenges, including:
- Administrative burdens such as EHR documentation, paperwork, prior authorizations, and staffing issues,
- Financial pressures, including competition with the employment packages offered by hospitals, as reimbursements continue to drop and staffing costs increase,
- Burnout,
- Variety of buy-ins and partnership tracks,
- Limited career development, and
- The strains of aging and endoscopy. “We used to joke in our practice that at any given time, three staff members are in physical therapy due to injuries and disabilities.”
Employing the Iceberg Model
One strategy, Khapra said, is to follow Edward T. Hall’s Iceberg Model of Culture , which focuses on the importance of both visible and invisible elements.
“The key to retention in private practice is to develop a value system where everyone is treated well and respected and compensated fairly,” she said. “That doesn’t mean you split the pie [equally].”
“Visible” elements of the model include the physical environment, policies and practices, symbols and behaviors, she said. While under the surface (“invisible” elements) are shared values, perceptions and attitudes, leadership style, conflict resolution, decision making and unwritten rules.
The key, she said, is to provide physicians an actual voice in decision making and to avoid favouritism, thus avoiding comments such as “Why do the same two people always get the prime scoping blocks?”
Financial transparency is also important, Khapra said. And people want flexibility without it being called special treatment. She provided several practical suggestions to accomplish the invisible Iceberg goals.
For instance, she suggested paying for activities outside the practice that physicians do, such as serving on committees. If the practice can’t afford that, she suggested asking the affiliated hospitals to do so, noting that such an initiative can often build community support.
Paying more attention to early associates than is typical can also benefit the practice, Khapra said. “So much effort is made to recruit them, and then once there, we’re on to the next [recruits].” Instead, she suggested, “pay attention to their needs.”
Providing support to physicians who are injured is also crucial and can foster a community culture, she said. For example, one Gastro Health physician was out for 4 weeks due to complications from surgery. “Everyone jumped in” to help fill the injured physician’s shifts, she said, reassuring the physician that the money would be figured out later. “That’s the culture you want to instill.”
To prevent burnout, another key to retaining physicians, “you have to provide support staff.” And offering good benefits, including parental and maternal leave and disability benefits, is also crucial, Khapra said. Consider practices such as having social dinners, another way to build a sense of community.
Finally, bring in national and local gastroenterologist organizations for discussions, including advocating for fair reimbursement for private practice. Consider working with the Digestive Health Physicians Alliance, which describes itself as the voice of independent gastroenterology, she suggested.
More Perspectives
Jami Kinnucan, MD, AGAF, a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville , Florida, spoke about optimizing recruitment of young gastroenterologists and provided perspective on Khapra’s talk.
“I think there’s a lot of overlap” with her topic and retaining private practice gastroenterologists, she said in an interview with GI & Hepatology News. Most important, she said, is having an efficient system in which the administrative flow is left to digital tools or other staff, not physicians. “That will also help to reduce burnout,” she said, and allow physicians to do what they most want to do, which is to focus on providing care to patients.
“People want to feel valued for their work,” she agreed. “People want opportunity for career development, opportunities for growth.”
As gastroenterologists age, flexibility is important, as it in in general for all physicians, Kinnucan said. She suggested schedule flexibility as one way. For instance, “if I tell 10 providers, ‘I need you to see 100 patients this week, but you can do it however you want,’ that promotes flexibility. They might want to see all of them on Monday and Tuesday, for instance. If you give people choice and autonomy, they are more likely to feel like they are part of the decision.”
How do you build a high-functioning team? “You do it by letting them operate autonomously,” and “you let people do the things they are really excited about.” And always, as Khapra said, focus on the invisible elements that are so crucial.
Khapra and Kinnucan had no relevant disclosures. Khapra received no funding for her presentation.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Barrett’s Esophagus: No Survival Difference Between Regular and At-Need Surveillance
SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?
Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.
, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week® (DDW) 2025.
At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.
The BOSS Trial
The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.
Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.
The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.
Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.
Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.
“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.
Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.
The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.
Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.
Will BOSS Change Minds?
Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.
However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”
The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.
Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”
Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.
Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.
While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”
The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?
Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.
, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week® (DDW) 2025.
At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.
The BOSS Trial
The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.
Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.
The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.
Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.
Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.
“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.
Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.
The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.
Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.
Will BOSS Change Minds?
Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.
However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”
The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.
Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”
Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.
Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.
While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”
The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?
Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.
, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week® (DDW) 2025.
At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.
The BOSS Trial
The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.
Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.
The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.
Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.
Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.
“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.
Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.
The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.
Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.
Will BOSS Change Minds?
Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.
However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”
The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.
Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”
Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.
Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.
While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”
The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Once-Monthly Efimosfermin Leads to Significant MASH Improvement in Phase 2 Trial
SAN DIEGO — , according to results of a phase 2 trial presented at Digestive Disease Week (DDW) 2025.
An analogue of the fibroblast growth factor 21 (FGF21) protein, the agent regulates metabolic processes to reduce liver fat. It has a half-life of about 21 days, said study presenter Margaret J. Koziel, MD, chief medical officer at Boston Pharmaceuticals.
MASH is marked by inflammation and fibrosis and can progress to cirrhosis and liver failure. About 2%-5% of US adults have MASH, according to the American College of Gastroenterology. Up to 20% of adults who are obese may have the condition.
The researchers randomly assigned 84 participants with biopsy-confirmed F2/F3 MASH to receive once-monthly injections of 300 mg efimosfermin alpha (43 patients) or placebo (41 patients) for 24 weeks.
The mean body mass index (BMI) of participants in both groups was about 37. Most study sites were in the southern United States, so that BMI “reflects the demographics,” Koziel said. Mean age was 55 years in the placebo group and 53 years in the treatment group, and about half of patients in both groups were women. Eighteen patients in each group had a fibrosis stage of F3.
Primary endpoints were safety and tolerability.
Exploratory objectives included the proportion of patients achieving fibrosis improvement of one or more stages without MASH worsening, MASH resolution without worsening of fibrosis, or both fibrosis improvement and MASH resolution.
Sixty-seven patients completed the treatment, and 65 post-baseline biopsies were collected — 34 in the placebo group and 31 in the treatment group.
Positive Results
“We saw statistically significant changes in fibrosis improvement,” Koziel said. “This has been the hardest barrier to hit.”
After 24 weeks, 45% of patients in the treatment group and 21% in the placebo group showed fibrosis improvement of one or more stages without worsening of MASH (P = .038), and 68% of those in the treatment group and 29% in the placebo group had MASH resolution without fibrosis worsening (P = .002).
The between-group difference in fibrosis improvement and MASH resolution did not reach statistical significance, with 39% of patients in the treatment group and 18% in the placebo group achieving the combined endpoint (P = .066). “It just missed statistical significance,” Koziel said, but she viewed the outcome as meaningful.
Additionally, “a third of the group taking efimosfermin normalized their liver fat, and all but one normalized their liver enzymes,” she said.
Adverse events — most often nausea, vomiting and diarrhea — were mild to moderate in both groups, Koziel said. In the treatment group, one patient withdrew from the study due to a grade 3 serious adverse event, and two others did so due to low-grade adverse events.
“These data support further development of once-monthly efimosfermin for the treatment of MASH-related fibrosis,” the research team concluded.
Hopeful Development
“Finally, there’s hope,” said DDW attendee Na Li, MD, associate clinical professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, Ohio, whose clinical focus is on metabolic-associated steatotic liver disease.
The new hope, she said, refers not only to the phase 2 study results but to the Food and Drug Administration approval of resmetirom (Rezdiffra) last year, which reduces liver fat by stimulating thyroid hormone receptor beta. “That was the first medication that got approved with a specific indication to treat MASH,” she said. Before that, lifestyle measures aimed at weight loss were the only approach.
Lifestyle measures are still important, Li said, but it’s helpful to have additional options. “There are quite a few agents in the pipeline now,” she said. One example is another FGF21 analogue efruxifermin, which is in phase 3 trials.
Li had no disclosures. Koziel declared being an employee of Boston Pharmaceuticals.
A version of this article appeared on Medscape.com.
SAN DIEGO — , according to results of a phase 2 trial presented at Digestive Disease Week (DDW) 2025.
An analogue of the fibroblast growth factor 21 (FGF21) protein, the agent regulates metabolic processes to reduce liver fat. It has a half-life of about 21 days, said study presenter Margaret J. Koziel, MD, chief medical officer at Boston Pharmaceuticals.
MASH is marked by inflammation and fibrosis and can progress to cirrhosis and liver failure. About 2%-5% of US adults have MASH, according to the American College of Gastroenterology. Up to 20% of adults who are obese may have the condition.
The researchers randomly assigned 84 participants with biopsy-confirmed F2/F3 MASH to receive once-monthly injections of 300 mg efimosfermin alpha (43 patients) or placebo (41 patients) for 24 weeks.
The mean body mass index (BMI) of participants in both groups was about 37. Most study sites were in the southern United States, so that BMI “reflects the demographics,” Koziel said. Mean age was 55 years in the placebo group and 53 years in the treatment group, and about half of patients in both groups were women. Eighteen patients in each group had a fibrosis stage of F3.
Primary endpoints were safety and tolerability.
Exploratory objectives included the proportion of patients achieving fibrosis improvement of one or more stages without MASH worsening, MASH resolution without worsening of fibrosis, or both fibrosis improvement and MASH resolution.
Sixty-seven patients completed the treatment, and 65 post-baseline biopsies were collected — 34 in the placebo group and 31 in the treatment group.
Positive Results
“We saw statistically significant changes in fibrosis improvement,” Koziel said. “This has been the hardest barrier to hit.”
After 24 weeks, 45% of patients in the treatment group and 21% in the placebo group showed fibrosis improvement of one or more stages without worsening of MASH (P = .038), and 68% of those in the treatment group and 29% in the placebo group had MASH resolution without fibrosis worsening (P = .002).
The between-group difference in fibrosis improvement and MASH resolution did not reach statistical significance, with 39% of patients in the treatment group and 18% in the placebo group achieving the combined endpoint (P = .066). “It just missed statistical significance,” Koziel said, but she viewed the outcome as meaningful.
Additionally, “a third of the group taking efimosfermin normalized their liver fat, and all but one normalized their liver enzymes,” she said.
Adverse events — most often nausea, vomiting and diarrhea — were mild to moderate in both groups, Koziel said. In the treatment group, one patient withdrew from the study due to a grade 3 serious adverse event, and two others did so due to low-grade adverse events.
“These data support further development of once-monthly efimosfermin for the treatment of MASH-related fibrosis,” the research team concluded.
Hopeful Development
“Finally, there’s hope,” said DDW attendee Na Li, MD, associate clinical professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, Ohio, whose clinical focus is on metabolic-associated steatotic liver disease.
The new hope, she said, refers not only to the phase 2 study results but to the Food and Drug Administration approval of resmetirom (Rezdiffra) last year, which reduces liver fat by stimulating thyroid hormone receptor beta. “That was the first medication that got approved with a specific indication to treat MASH,” she said. Before that, lifestyle measures aimed at weight loss were the only approach.
Lifestyle measures are still important, Li said, but it’s helpful to have additional options. “There are quite a few agents in the pipeline now,” she said. One example is another FGF21 analogue efruxifermin, which is in phase 3 trials.
Li had no disclosures. Koziel declared being an employee of Boston Pharmaceuticals.
A version of this article appeared on Medscape.com.
SAN DIEGO — , according to results of a phase 2 trial presented at Digestive Disease Week (DDW) 2025.
An analogue of the fibroblast growth factor 21 (FGF21) protein, the agent regulates metabolic processes to reduce liver fat. It has a half-life of about 21 days, said study presenter Margaret J. Koziel, MD, chief medical officer at Boston Pharmaceuticals.
MASH is marked by inflammation and fibrosis and can progress to cirrhosis and liver failure. About 2%-5% of US adults have MASH, according to the American College of Gastroenterology. Up to 20% of adults who are obese may have the condition.
The researchers randomly assigned 84 participants with biopsy-confirmed F2/F3 MASH to receive once-monthly injections of 300 mg efimosfermin alpha (43 patients) or placebo (41 patients) for 24 weeks.
The mean body mass index (BMI) of participants in both groups was about 37. Most study sites were in the southern United States, so that BMI “reflects the demographics,” Koziel said. Mean age was 55 years in the placebo group and 53 years in the treatment group, and about half of patients in both groups were women. Eighteen patients in each group had a fibrosis stage of F3.
Primary endpoints were safety and tolerability.
Exploratory objectives included the proportion of patients achieving fibrosis improvement of one or more stages without MASH worsening, MASH resolution without worsening of fibrosis, or both fibrosis improvement and MASH resolution.
Sixty-seven patients completed the treatment, and 65 post-baseline biopsies were collected — 34 in the placebo group and 31 in the treatment group.
Positive Results
“We saw statistically significant changes in fibrosis improvement,” Koziel said. “This has been the hardest barrier to hit.”
After 24 weeks, 45% of patients in the treatment group and 21% in the placebo group showed fibrosis improvement of one or more stages without worsening of MASH (P = .038), and 68% of those in the treatment group and 29% in the placebo group had MASH resolution without fibrosis worsening (P = .002).
The between-group difference in fibrosis improvement and MASH resolution did not reach statistical significance, with 39% of patients in the treatment group and 18% in the placebo group achieving the combined endpoint (P = .066). “It just missed statistical significance,” Koziel said, but she viewed the outcome as meaningful.
Additionally, “a third of the group taking efimosfermin normalized their liver fat, and all but one normalized their liver enzymes,” she said.
Adverse events — most often nausea, vomiting and diarrhea — were mild to moderate in both groups, Koziel said. In the treatment group, one patient withdrew from the study due to a grade 3 serious adverse event, and two others did so due to low-grade adverse events.
“These data support further development of once-monthly efimosfermin for the treatment of MASH-related fibrosis,” the research team concluded.
Hopeful Development
“Finally, there’s hope,” said DDW attendee Na Li, MD, associate clinical professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, Ohio, whose clinical focus is on metabolic-associated steatotic liver disease.
The new hope, she said, refers not only to the phase 2 study results but to the Food and Drug Administration approval of resmetirom (Rezdiffra) last year, which reduces liver fat by stimulating thyroid hormone receptor beta. “That was the first medication that got approved with a specific indication to treat MASH,” she said. Before that, lifestyle measures aimed at weight loss were the only approach.
Lifestyle measures are still important, Li said, but it’s helpful to have additional options. “There are quite a few agents in the pipeline now,” she said. One example is another FGF21 analogue efruxifermin, which is in phase 3 trials.
Li had no disclosures. Koziel declared being an employee of Boston Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Weekend Workout, Regular Exercise Are Equals at Lowering GI Disease Risk
SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”
Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.
Both patterns reduce digestive disease almost equally.
Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.
Her bottom line: “Your gut does not care about your schedule.”
The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.
They divided participants into three groups:
- About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
- About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
- About 34% were inactive participants who were active less than 150 minutes a week.
The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease.
,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.
The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.
As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.
A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.
A Pleasant Surprise
The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.
“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”
“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”
Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.
This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”
Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.
Both patterns reduce digestive disease almost equally.
Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.
Her bottom line: “Your gut does not care about your schedule.”
The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.
They divided participants into three groups:
- About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
- About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
- About 34% were inactive participants who were active less than 150 minutes a week.
The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease.
,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.
The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.
As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.
A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.
A Pleasant Surprise
The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.
“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”
“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”
Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.
This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.
A version of this article appeared on Medscape.com.
SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”
Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.
Both patterns reduce digestive disease almost equally.
Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.
Her bottom line: “Your gut does not care about your schedule.”
The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.
They divided participants into three groups:
- About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
- About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
- About 34% were inactive participants who were active less than 150 minutes a week.
The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease.
,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.
The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.
As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.
A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.
A Pleasant Surprise
The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.
“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”
“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”
Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.
This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.
A version of this article appeared on Medscape.com.
FROM DDW 2025
Using GLP-1s to Meet BMI Goal for Orthopedic Surgery
The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.
“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.
They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.
“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.
It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”
As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”
Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.
She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.
High BMIs & Surgery Issues
High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.
These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.
Making the GLP-1 Choice
GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.
With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.
The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.
The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.
Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.
Growing Partnerships, Increasing Success
Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.
When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.
Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.
Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.
She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).
Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.
Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.
Insurance Issues
Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.
However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal
Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.
A version of this article appeared on Medscape.com.
The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.
“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.
They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.
“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.
It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”
As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”
Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.
She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.
High BMIs & Surgery Issues
High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.
These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.
Making the GLP-1 Choice
GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.
With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.
The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.
The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.
Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.
Growing Partnerships, Increasing Success
Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.
When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.
Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.
Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.
She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).
Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.
Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.
Insurance Issues
Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.
However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal
Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.
A version of this article appeared on Medscape.com.
The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.
“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.
They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.
“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.
It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”
As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”
Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.
She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.
High BMIs & Surgery Issues
High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.
These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.
Making the GLP-1 Choice
GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.
With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.
The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.
The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.
Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.
Growing Partnerships, Increasing Success
Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.
When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.
Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.
Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.
She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).
Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.
Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.
Insurance Issues
Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.
However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal
Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.
A version of this article appeared on Medscape.com.
Gambling Disorder on the Rise, but Often Overlooked
On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.
“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.
The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.
Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.
according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.
Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.
The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.
A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.
But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.
Gritty Reputation Goes Glam, With No Shortage of Opportunities
Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”
Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”
With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.
However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”
In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.
Seeing the Red Flags
“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.
Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.”
Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.
Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.
Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.
The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”
Inside a Gambler’s Brain
Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.
The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.
Seeking Treatment
One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.
To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:
- The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
- The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.
“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”
To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.
For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.
Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.
To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.
Goal: Cold Turkey or Harm Reduction?
Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.
“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”
Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”
Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.
A version of this article appeared on Medscape.com.
On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.
“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.
The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.
Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.
according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.
Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.
The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.
A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.
But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.
Gritty Reputation Goes Glam, With No Shortage of Opportunities
Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”
Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”
With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.
However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”
In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.
Seeing the Red Flags
“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.
Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.”
Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.
Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.
Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.
The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”
Inside a Gambler’s Brain
Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.
The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.
Seeking Treatment
One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.
To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:
- The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
- The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.
“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”
To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.
For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.
Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.
To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.
Goal: Cold Turkey or Harm Reduction?
Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.
“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”
Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”
Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.
A version of this article appeared on Medscape.com.
On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.
“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.
The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.
Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.
according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.
Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.
The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.
A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.
But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.
Gritty Reputation Goes Glam, With No Shortage of Opportunities
Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”
Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”
With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.
However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”
In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.
Seeing the Red Flags
“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.
Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.”
Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.
Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.
Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.
The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”
Inside a Gambler’s Brain
Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.
The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.
Seeking Treatment
One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.
To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:
- The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
- The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.
“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”
To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.
For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.
Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.
To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.
Goal: Cold Turkey or Harm Reduction?
Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.
“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”
Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”
Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.
A version of this article appeared on Medscape.com.
Your Guide to COVID Vaccines for 2024-2025
The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.
As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.
This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.
As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.
Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.
Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.
What’s Available?
Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:
Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.
Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
How Effective Are They?
Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.
How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.
Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.
What About Side Effects?
The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.
Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.
Which One Is Best?
“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”
He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”
Best Time to Get It?
“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.
What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.
Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.
Coverage
Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.
A version of this article first appeared on WebMD.
The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.
As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.
This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.
As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.
Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.
Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.
What’s Available?
Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:
Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.
Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
How Effective Are They?
Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.
How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.
Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.
What About Side Effects?
The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.
Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.
Which One Is Best?
“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”
He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”
Best Time to Get It?
“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.
What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.
Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.
Coverage
Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.
A version of this article first appeared on WebMD.
The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.
As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.
This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.
As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.
Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.
Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.
What’s Available?
Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:
Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.
Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.
How Effective Are They?
Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.
How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.
Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.
What About Side Effects?
The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.
Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.
Which One Is Best?
“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”
He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”
Best Time to Get It?
“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.
What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.
Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.
Coverage
Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.
A version of this article first appeared on WebMD.
Obesity Medications: Could Coverage Offset Obesity Care Costs?
The question may seem simple: , such as cardiovascular disease and diabetes?
It’s a question that’s getting an increased amount of attention.
And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.
Among recent developments:
- A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
- As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
- Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
- Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.
CMS Proposal
In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.
Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.
Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”
The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”
The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.
Expert Analyses: Emory, Cornell, Southern California
So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.
Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.
The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.
Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”
These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”
Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.
However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.
The Congressional Budget Office View
In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.
Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.
Expert Analysis: USC Schaeffer Center
“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”
However, treating obesity means people will live longer, “and living longer costs more,” she said.
She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.
In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”
While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.
Lilly UK Trial
A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.
Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.
Beyond Health: The Value of Weight Loss
“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.
“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”
However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”
Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
A version of this article appeared on Medscape.com.
The question may seem simple: , such as cardiovascular disease and diabetes?
It’s a question that’s getting an increased amount of attention.
And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.
Among recent developments:
- A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
- As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
- Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
- Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.
CMS Proposal
In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.
Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.
Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”
The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”
The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.
Expert Analyses: Emory, Cornell, Southern California
So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.
Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.
The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.
Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”
These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”
Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.
However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.
The Congressional Budget Office View
In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.
Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.
Expert Analysis: USC Schaeffer Center
“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”
However, treating obesity means people will live longer, “and living longer costs more,” she said.
She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.
In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”
While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.
Lilly UK Trial
A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.
Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.
Beyond Health: The Value of Weight Loss
“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.
“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”
However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”
Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
A version of this article appeared on Medscape.com.
The question may seem simple: , such as cardiovascular disease and diabetes?
It’s a question that’s getting an increased amount of attention.
And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.
Among recent developments:
- A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
- As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
- Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
- Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.
CMS Proposal
In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.
Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.
Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”
The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”
The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.
Expert Analyses: Emory, Cornell, Southern California
So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.
Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.
The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.
Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”
These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”
Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.
However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.
The Congressional Budget Office View
In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.
Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.
Expert Analysis: USC Schaeffer Center
“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”
However, treating obesity means people will live longer, “and living longer costs more,” she said.
She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.
In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”
While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.
Lilly UK Trial
A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.
Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.
Beyond Health: The Value of Weight Loss
“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.
“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”
However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”
Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
A version of this article appeared on Medscape.com.