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The results of the SUMMIT trial of the long-acting agonist of glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, tirzepatide, in patients with heart failure with preserved ejection fraction (HFpEF) and obesity are positive. But the trial design leaves clinicians and regulators with big doses of uncertainty.

Known Facts About HFpEF

HFpEF has exceeded heart failure with reduced ejection fraction (HFrEF) as the most common form of heart failure. HFpEF differs from HFrEF in that patients with preserved ejection fraction often present later in life with more comorbidities.

Some of these comorbidities are on the causal pathway of heart failure. Obesity, for instance, both associates with HFpEF and surely causes the diastolic dysfunction central to the condition. This may be a direct effect via high excess adipose tissue or an indirect effect via pro-inflammatory pathways.

GLP-1 agonists and the dual-acting GIP/GLP1 agonist tirzepatide have proven efficacy for weight loss. Semaglutide has previously been shown to improve quality of life and physical functioning in two small trials of patients with HFpEF and obesity. Semaglutide also reduced hard clinical outcomes in patients with obesity and these other conditions: chronic kidney disease, diabetes, and established atherosclerotic vascular disease.

This class of drugs is costly. The combination of both high drug costs and highly prevalent conditions such as obesity and HFpEF forces clinicians to make both value and clinical judgments when translating evidence.

 

The SUMMIT Trial

The SUMMIT trial aimed to evaluate tirzepatide’s effect on typical heart failure events, health status and functional capacity in patients with obesity and HFpEF. A total of 731 patients were randomly assigned to receive to tirzepatide or placebo.

Investigators chose two co-primary endpoints. The first was a composite of cardiovascular (CV) death and worsening heart failure events—the latter could be a hospitalization for heart failure, a visit for intravenous diuretics, or intensification of oral diuretics. The idea behind this rather unique composite was to capture all heart failure events. The second co-primary endpoint was a change in baseline Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) at 1 year.

Characteristics of the patients included an average age of 65 years, 55% were female, the average body mass index was 38, and the mean left ventricular ejection fraction was 61% (the minimum for trial entry was 50%). Just under half had been hospitalized for heart failure in the year before trial entry.

 

Tirzepatide Results

The primary outcome of CV death and first heart failure event occurred in 36 patients (9.9%) in the tirzepatide group and 56 patients (15.3%) in the placebo group, for a hazard ratio of 0.62 (95% CI, 0.41-0.95; P =.026).

The 5.4% absolute risk reduction in the primary endpoint was completely driven by lower rates of heart failure events (8% vs 14.2%). CV death was actually higher in the tirzepatide arm, but the number of deaths was low in both arms (8 vs 5).

The rate of hospitalizations due to heart failure was lower with tirzepatide (3.3% vs 7.1%), as was intensification of oral diuretics (4.7% vs 5.7%).

The second co-primary endpoint of change from baseline in KCCQ-CSS favored tirzepatide.

Other secondary endpoints also favored tirzepatide: longer 6-minute walk distance, greater change in body weight (-11.6%), and lower high-sensitivity C-reactive protein levels and systolic blood pressure (-4.7 mm Hg).

 

Authors’ Conclusions and Expert Comments

At the American Heart Association Scientific Sessions, the primary investigator Milton Packer, MD, said SUMMIT was the first trial of patients with obesity and HFpEF that had major heart failure outcomes as the primary endpoint. And that tirzepatide changed the clinical trajectory of the disease.

Jennifer Ho, MD, associate professor of medicine at Harvard Medical School, Boston, Massachusetts, said, “This really is a practice-changing trial and cements this type of therapy as one of the cornerstones of obesity and HFpEF treatment.”

Other experts cited a recently published pooled analysis of semaglutide trials looking specifically at patients with HFpEF and found lower rates of HF events with the GLP-1 agonist.

The SUMMIT trial results were covered in 53 news outlets— nearly all with glowing headlines.

 

My Six Concerns With SUMMIT

The trial delivered statistically positive findings. What’s more, patients lost weight, and a greater than 11% weight loss difference is meaningful. Patients with a baseline weight of more than 100 kg who lose this much weight are bound to feel and function better.

The first problem comes when we ask whether the results are disease-modifying. There was no difference in CV death. And the number of hospitalizations for heart failure — the more standard endpoint — was low, at only 12 and 26, respectively. Contrast this with the DELIVER trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in HFpEF where there were nearly 750 hospitalizations for heart failure and PARAGON-HF of sacubitril-valsartan vs valsartan in HFpEF, where there were nearly 1500. SUMMIT simply had too few events to make conclusions — a point Packer has made regarding AF ablation trials in patients with heart failure.

I have previously called GLP-1 drugs disease-modifying in patients with obesity and atherosclerotic disease. This is because the SELECT trial of semaglutide randomized more than 17,000 patients and recorded a 20% reduction in hard outcomes. And there were more than 1200 primary outcome events. SUMMIT does not come close to this measure.

The second issue is short follow-up. These were 65-year-old patients and with only 2 years of follow-up, it is hard to make conclusions regarding whether or not these drugs can provide long-term benefit.

The third issue is that SUMMIT authors don’t tell us the number of all-cause hospitalizations. I was part of a recently published meta-analysis of more than 100 heart failure trials that raised questions regarding the value of hospitalizations for heart failure as a surrogate for heart failure outcomes.

For instance, we found that in large trials there was great variability in the ability of a reduction in HF hospitalizations to predict a reduction in all-cause hospitalization. In small trials, such as SUMMIT, it would likely be impossible to predict how the reduction in HF hospitalization would predict all-cause hospitalization. I believe all-cause hospitalization is a more inclusive endpoint because it is bias free; it captures benefits and potential harms of the therapy; and it is patient-centered, because patients probably do not care what type of hospitalization they avoid.

The fourth issue with SUMMIT is the difficulty in maintaining blinding, which reduces confidence in outcomes that require clinical decisions or patient judgments. Owing to gastrointestinal symptoms, decreased appetite, and weight loss, patients on this class of drugs are very likely to know their treatment assignment. This is a criticism of not only SUMMIT but all GLP-1 agonist trials. The fact that blinding is difficult to maintain argues for choosing endpoints less susceptible to bias, such as CV death or all-cause hospitalization.

Proponents of tirzepatide for this indication might argue that unblinding is less of an issue because of objective endpoints such as biomarkers. And they have a point, but nearly all other endpoints, especially the co-primary endpoint of KCCQ-CSS, are largely susceptible to bias.

The fifth and main problem comes in translating this evidence in the clinic. Should doctors give up on nondrug means of weight loss? All of the positive outcome trials in this class of drugs have also shown weight loss. I believe we should take these data and use them to re-invigorate our advocacy for weight loss without medication. I know the standard answer to this proposal is nihilism: It just will not work. And I cannot deny that we have failed previously in our efforts to help patients lose weight. But perhaps now, with the vast amount of data, we can be more persuasive. Imagine a world where key opinion leaders made weight loss the message rather than prescription of a drug.

Finally, if you approach SUMMIT from the view of a regulator, with its small numbers of outcome events and bias-susceptible endpoints, you cannot allow a disease-modifying claim. For that we would need a properly powered trial that shows that the drug reduces both CV death and all-cause hospitalization.

In the end, SUMMIT is not close to changing treatment norms in patients with HFpEF. As evidence-based clinicians, we should demand more from our partners in industry and academia.

Dr. Mandrola practices cardiac electrophysiology in Baptist Medical Associates, Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

 

A version of this article first appeared on Medscape.com.

The results of the SUMMIT trial of the long-acting agonist of glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, tirzepatide, in patients with heart failure with preserved ejection fraction (HFpEF) and obesity are positive. But the trial design leaves clinicians and regulators with big doses of uncertainty.

Known Facts About HFpEF

HFpEF has exceeded heart failure with reduced ejection fraction (HFrEF) as the most common form of heart failure. HFpEF differs from HFrEF in that patients with preserved ejection fraction often present later in life with more comorbidities.

Some of these comorbidities are on the causal pathway of heart failure. Obesity, for instance, both associates with HFpEF and surely causes the diastolic dysfunction central to the condition. This may be a direct effect via high excess adipose tissue or an indirect effect via pro-inflammatory pathways.

GLP-1 agonists and the dual-acting GIP/GLP1 agonist tirzepatide have proven efficacy for weight loss. Semaglutide has previously been shown to improve quality of life and physical functioning in two small trials of patients with HFpEF and obesity. Semaglutide also reduced hard clinical outcomes in patients with obesity and these other conditions: chronic kidney disease, diabetes, and established atherosclerotic vascular disease.

This class of drugs is costly. The combination of both high drug costs and highly prevalent conditions such as obesity and HFpEF forces clinicians to make both value and clinical judgments when translating evidence.

 

The SUMMIT Trial

The SUMMIT trial aimed to evaluate tirzepatide’s effect on typical heart failure events, health status and functional capacity in patients with obesity and HFpEF. A total of 731 patients were randomly assigned to receive to tirzepatide or placebo.

Investigators chose two co-primary endpoints. The first was a composite of cardiovascular (CV) death and worsening heart failure events—the latter could be a hospitalization for heart failure, a visit for intravenous diuretics, or intensification of oral diuretics. The idea behind this rather unique composite was to capture all heart failure events. The second co-primary endpoint was a change in baseline Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) at 1 year.

Characteristics of the patients included an average age of 65 years, 55% were female, the average body mass index was 38, and the mean left ventricular ejection fraction was 61% (the minimum for trial entry was 50%). Just under half had been hospitalized for heart failure in the year before trial entry.

 

Tirzepatide Results

The primary outcome of CV death and first heart failure event occurred in 36 patients (9.9%) in the tirzepatide group and 56 patients (15.3%) in the placebo group, for a hazard ratio of 0.62 (95% CI, 0.41-0.95; P =.026).

The 5.4% absolute risk reduction in the primary endpoint was completely driven by lower rates of heart failure events (8% vs 14.2%). CV death was actually higher in the tirzepatide arm, but the number of deaths was low in both arms (8 vs 5).

The rate of hospitalizations due to heart failure was lower with tirzepatide (3.3% vs 7.1%), as was intensification of oral diuretics (4.7% vs 5.7%).

The second co-primary endpoint of change from baseline in KCCQ-CSS favored tirzepatide.

Other secondary endpoints also favored tirzepatide: longer 6-minute walk distance, greater change in body weight (-11.6%), and lower high-sensitivity C-reactive protein levels and systolic blood pressure (-4.7 mm Hg).

 

Authors’ Conclusions and Expert Comments

At the American Heart Association Scientific Sessions, the primary investigator Milton Packer, MD, said SUMMIT was the first trial of patients with obesity and HFpEF that had major heart failure outcomes as the primary endpoint. And that tirzepatide changed the clinical trajectory of the disease.

Jennifer Ho, MD, associate professor of medicine at Harvard Medical School, Boston, Massachusetts, said, “This really is a practice-changing trial and cements this type of therapy as one of the cornerstones of obesity and HFpEF treatment.”

Other experts cited a recently published pooled analysis of semaglutide trials looking specifically at patients with HFpEF and found lower rates of HF events with the GLP-1 agonist.

The SUMMIT trial results were covered in 53 news outlets— nearly all with glowing headlines.

 

My Six Concerns With SUMMIT

The trial delivered statistically positive findings. What’s more, patients lost weight, and a greater than 11% weight loss difference is meaningful. Patients with a baseline weight of more than 100 kg who lose this much weight are bound to feel and function better.

The first problem comes when we ask whether the results are disease-modifying. There was no difference in CV death. And the number of hospitalizations for heart failure — the more standard endpoint — was low, at only 12 and 26, respectively. Contrast this with the DELIVER trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in HFpEF where there were nearly 750 hospitalizations for heart failure and PARAGON-HF of sacubitril-valsartan vs valsartan in HFpEF, where there were nearly 1500. SUMMIT simply had too few events to make conclusions — a point Packer has made regarding AF ablation trials in patients with heart failure.

I have previously called GLP-1 drugs disease-modifying in patients with obesity and atherosclerotic disease. This is because the SELECT trial of semaglutide randomized more than 17,000 patients and recorded a 20% reduction in hard outcomes. And there were more than 1200 primary outcome events. SUMMIT does not come close to this measure.

The second issue is short follow-up. These were 65-year-old patients and with only 2 years of follow-up, it is hard to make conclusions regarding whether or not these drugs can provide long-term benefit.

The third issue is that SUMMIT authors don’t tell us the number of all-cause hospitalizations. I was part of a recently published meta-analysis of more than 100 heart failure trials that raised questions regarding the value of hospitalizations for heart failure as a surrogate for heart failure outcomes.

For instance, we found that in large trials there was great variability in the ability of a reduction in HF hospitalizations to predict a reduction in all-cause hospitalization. In small trials, such as SUMMIT, it would likely be impossible to predict how the reduction in HF hospitalization would predict all-cause hospitalization. I believe all-cause hospitalization is a more inclusive endpoint because it is bias free; it captures benefits and potential harms of the therapy; and it is patient-centered, because patients probably do not care what type of hospitalization they avoid.

The fourth issue with SUMMIT is the difficulty in maintaining blinding, which reduces confidence in outcomes that require clinical decisions or patient judgments. Owing to gastrointestinal symptoms, decreased appetite, and weight loss, patients on this class of drugs are very likely to know their treatment assignment. This is a criticism of not only SUMMIT but all GLP-1 agonist trials. The fact that blinding is difficult to maintain argues for choosing endpoints less susceptible to bias, such as CV death or all-cause hospitalization.

Proponents of tirzepatide for this indication might argue that unblinding is less of an issue because of objective endpoints such as biomarkers. And they have a point, but nearly all other endpoints, especially the co-primary endpoint of KCCQ-CSS, are largely susceptible to bias.

The fifth and main problem comes in translating this evidence in the clinic. Should doctors give up on nondrug means of weight loss? All of the positive outcome trials in this class of drugs have also shown weight loss. I believe we should take these data and use them to re-invigorate our advocacy for weight loss without medication. I know the standard answer to this proposal is nihilism: It just will not work. And I cannot deny that we have failed previously in our efforts to help patients lose weight. But perhaps now, with the vast amount of data, we can be more persuasive. Imagine a world where key opinion leaders made weight loss the message rather than prescription of a drug.

Finally, if you approach SUMMIT from the view of a regulator, with its small numbers of outcome events and bias-susceptible endpoints, you cannot allow a disease-modifying claim. For that we would need a properly powered trial that shows that the drug reduces both CV death and all-cause hospitalization.

In the end, SUMMIT is not close to changing treatment norms in patients with HFpEF. As evidence-based clinicians, we should demand more from our partners in industry and academia.

Dr. Mandrola practices cardiac electrophysiology in Baptist Medical Associates, Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

 

A version of this article first appeared on Medscape.com.

The results of the SUMMIT trial of the long-acting agonist of glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, tirzepatide, in patients with heart failure with preserved ejection fraction (HFpEF) and obesity are positive. But the trial design leaves clinicians and regulators with big doses of uncertainty.

Known Facts About HFpEF

HFpEF has exceeded heart failure with reduced ejection fraction (HFrEF) as the most common form of heart failure. HFpEF differs from HFrEF in that patients with preserved ejection fraction often present later in life with more comorbidities.

Some of these comorbidities are on the causal pathway of heart failure. Obesity, for instance, both associates with HFpEF and surely causes the diastolic dysfunction central to the condition. This may be a direct effect via high excess adipose tissue or an indirect effect via pro-inflammatory pathways.

GLP-1 agonists and the dual-acting GIP/GLP1 agonist tirzepatide have proven efficacy for weight loss. Semaglutide has previously been shown to improve quality of life and physical functioning in two small trials of patients with HFpEF and obesity. Semaglutide also reduced hard clinical outcomes in patients with obesity and these other conditions: chronic kidney disease, diabetes, and established atherosclerotic vascular disease.

This class of drugs is costly. The combination of both high drug costs and highly prevalent conditions such as obesity and HFpEF forces clinicians to make both value and clinical judgments when translating evidence.

 

The SUMMIT Trial

The SUMMIT trial aimed to evaluate tirzepatide’s effect on typical heart failure events, health status and functional capacity in patients with obesity and HFpEF. A total of 731 patients were randomly assigned to receive to tirzepatide or placebo.

Investigators chose two co-primary endpoints. The first was a composite of cardiovascular (CV) death and worsening heart failure events—the latter could be a hospitalization for heart failure, a visit for intravenous diuretics, or intensification of oral diuretics. The idea behind this rather unique composite was to capture all heart failure events. The second co-primary endpoint was a change in baseline Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) at 1 year.

Characteristics of the patients included an average age of 65 years, 55% were female, the average body mass index was 38, and the mean left ventricular ejection fraction was 61% (the minimum for trial entry was 50%). Just under half had been hospitalized for heart failure in the year before trial entry.

 

Tirzepatide Results

The primary outcome of CV death and first heart failure event occurred in 36 patients (9.9%) in the tirzepatide group and 56 patients (15.3%) in the placebo group, for a hazard ratio of 0.62 (95% CI, 0.41-0.95; P =.026).

The 5.4% absolute risk reduction in the primary endpoint was completely driven by lower rates of heart failure events (8% vs 14.2%). CV death was actually higher in the tirzepatide arm, but the number of deaths was low in both arms (8 vs 5).

The rate of hospitalizations due to heart failure was lower with tirzepatide (3.3% vs 7.1%), as was intensification of oral diuretics (4.7% vs 5.7%).

The second co-primary endpoint of change from baseline in KCCQ-CSS favored tirzepatide.

Other secondary endpoints also favored tirzepatide: longer 6-minute walk distance, greater change in body weight (-11.6%), and lower high-sensitivity C-reactive protein levels and systolic blood pressure (-4.7 mm Hg).

 

Authors’ Conclusions and Expert Comments

At the American Heart Association Scientific Sessions, the primary investigator Milton Packer, MD, said SUMMIT was the first trial of patients with obesity and HFpEF that had major heart failure outcomes as the primary endpoint. And that tirzepatide changed the clinical trajectory of the disease.

Jennifer Ho, MD, associate professor of medicine at Harvard Medical School, Boston, Massachusetts, said, “This really is a practice-changing trial and cements this type of therapy as one of the cornerstones of obesity and HFpEF treatment.”

Other experts cited a recently published pooled analysis of semaglutide trials looking specifically at patients with HFpEF and found lower rates of HF events with the GLP-1 agonist.

The SUMMIT trial results were covered in 53 news outlets— nearly all with glowing headlines.

 

My Six Concerns With SUMMIT

The trial delivered statistically positive findings. What’s more, patients lost weight, and a greater than 11% weight loss difference is meaningful. Patients with a baseline weight of more than 100 kg who lose this much weight are bound to feel and function better.

The first problem comes when we ask whether the results are disease-modifying. There was no difference in CV death. And the number of hospitalizations for heart failure — the more standard endpoint — was low, at only 12 and 26, respectively. Contrast this with the DELIVER trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in HFpEF where there were nearly 750 hospitalizations for heart failure and PARAGON-HF of sacubitril-valsartan vs valsartan in HFpEF, where there were nearly 1500. SUMMIT simply had too few events to make conclusions — a point Packer has made regarding AF ablation trials in patients with heart failure.

I have previously called GLP-1 drugs disease-modifying in patients with obesity and atherosclerotic disease. This is because the SELECT trial of semaglutide randomized more than 17,000 patients and recorded a 20% reduction in hard outcomes. And there were more than 1200 primary outcome events. SUMMIT does not come close to this measure.

The second issue is short follow-up. These were 65-year-old patients and with only 2 years of follow-up, it is hard to make conclusions regarding whether or not these drugs can provide long-term benefit.

The third issue is that SUMMIT authors don’t tell us the number of all-cause hospitalizations. I was part of a recently published meta-analysis of more than 100 heart failure trials that raised questions regarding the value of hospitalizations for heart failure as a surrogate for heart failure outcomes.

For instance, we found that in large trials there was great variability in the ability of a reduction in HF hospitalizations to predict a reduction in all-cause hospitalization. In small trials, such as SUMMIT, it would likely be impossible to predict how the reduction in HF hospitalization would predict all-cause hospitalization. I believe all-cause hospitalization is a more inclusive endpoint because it is bias free; it captures benefits and potential harms of the therapy; and it is patient-centered, because patients probably do not care what type of hospitalization they avoid.

The fourth issue with SUMMIT is the difficulty in maintaining blinding, which reduces confidence in outcomes that require clinical decisions or patient judgments. Owing to gastrointestinal symptoms, decreased appetite, and weight loss, patients on this class of drugs are very likely to know their treatment assignment. This is a criticism of not only SUMMIT but all GLP-1 agonist trials. The fact that blinding is difficult to maintain argues for choosing endpoints less susceptible to bias, such as CV death or all-cause hospitalization.

Proponents of tirzepatide for this indication might argue that unblinding is less of an issue because of objective endpoints such as biomarkers. And they have a point, but nearly all other endpoints, especially the co-primary endpoint of KCCQ-CSS, are largely susceptible to bias.

The fifth and main problem comes in translating this evidence in the clinic. Should doctors give up on nondrug means of weight loss? All of the positive outcome trials in this class of drugs have also shown weight loss. I believe we should take these data and use them to re-invigorate our advocacy for weight loss without medication. I know the standard answer to this proposal is nihilism: It just will not work. And I cannot deny that we have failed previously in our efforts to help patients lose weight. But perhaps now, with the vast amount of data, we can be more persuasive. Imagine a world where key opinion leaders made weight loss the message rather than prescription of a drug.

Finally, if you approach SUMMIT from the view of a regulator, with its small numbers of outcome events and bias-susceptible endpoints, you cannot allow a disease-modifying claim. For that we would need a properly powered trial that shows that the drug reduces both CV death and all-cause hospitalization.

In the end, SUMMIT is not close to changing treatment norms in patients with HFpEF. As evidence-based clinicians, we should demand more from our partners in industry and academia.

Dr. Mandrola practices cardiac electrophysiology in Baptist Medical Associates, Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

 

A version of this article first appeared on Medscape.com.

TOPLINE:

Between 2010 and 2022, hospital-based obstetric care declined significantly across the United States, with 52.4% of rural hospitals and 35.7% of urban hospitals not offering obstetric services by 2022. Rural hospitals experienced a steeper increase in the percentage of facilities without obstetrics than urban counterparts, despite several national maternity care access initiatives.

METHODOLOGY:

• Researchers conducted a retrospective cohort study of 4964 United States short-term acute care hospitals, including 1982 in rural counties and 2982 in urban counties, analyzing data from 2010 to 2022.
• Analysis utilized American Hospital Association annual surveys and Centers for Medicare & Medicaid Services Provider of Services files, applying an enhanced algorithm to identify hospital-based obstetric services availability.
• Hospital rurality classification followed Office of Management and Budget definitions, with urban hospitals located in metropolitan statistical areas having > 250,000 inhabitants and rural hospitals in nonmetropolitan areas with < 50,000 inhabitants.

TAKEAWAY:

• A total of 537 hospitals lost obstetric services between 2010 and 2022, with 238 rural hospitals and 299 urban hospitals affected, while only 138 hospitals gained obstetric services during this period.
• The percentage of hospitals without obstetrics increased steadily from 35.2% to 42.4% of all hospitals between 2010 and 2022, with rural hospitals consistently showing higher rates than urban facilities.
• By 2022, more than half (52.4%) of rural hospitals and over one third (35.7%) of urban hospitals did not offer obstetric care, representing a significant decline in access to maternal healthcare services.
• Urban areas showed greater potential for service recovery with 112 hospitals gaining obstetric services than only 26 rural hospitals during the study period.

IN PRACTICE:

“Access to obstetric care is an important determinant of maternal and infant health outcomes, and amidst a maternal health crisis in the US, hospital-based obstetric care has declined in both rural and urban communities,” wrote the authors of the study.

SOURCE:

The study was led by Katy B. Kozhimannil, PhD, MPA, Division of Health Policy and Management, University of Minnesota School of Public Health in Minneapolis. It was published online on December 4 in JAMA.

LIMITATIONS: 

The study was limited by the lack of data on births outside hospital settings, which represent less than 2% of United States births. Additionally, the denominator for the study outcome declined each year because of hospital closures, particularly affecting rural hospitals. The researchers also noted that while rurality exists on a continuum, they applied a dichotomous county–based measure of hospital location. Furthermore, the hospital-level data did not contain patient-level information, making it impossible to analyze how changes in obstetric status affected patient outcomes. 

DISCLOSURES:

This study was supported by the Federal Office of Rural Health Policy, Health Resources and Services Administration, Department of Health & Human Services under Public Health Service Cooperative Agreement. One coauthor disclosed receiving grants from the Laura and John Arnold Foundation, Ballad Health, and the Commonwealth Fund outside the submitted work. A coauthor reported receiving personal fees from the American Institute of Biological Sciences on behalf of March of Dimes as a grant reviewer. Another coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Between 2010 and 2022, hospital-based obstetric care declined significantly across the United States, with 52.4% of rural hospitals and 35.7% of urban hospitals not offering obstetric services by 2022. Rural hospitals experienced a steeper increase in the percentage of facilities without obstetrics than urban counterparts, despite several national maternity care access initiatives.

METHODOLOGY:

• Researchers conducted a retrospective cohort study of 4964 United States short-term acute care hospitals, including 1982 in rural counties and 2982 in urban counties, analyzing data from 2010 to 2022.
• Analysis utilized American Hospital Association annual surveys and Centers for Medicare & Medicaid Services Provider of Services files, applying an enhanced algorithm to identify hospital-based obstetric services availability.
• Hospital rurality classification followed Office of Management and Budget definitions, with urban hospitals located in metropolitan statistical areas having > 250,000 inhabitants and rural hospitals in nonmetropolitan areas with < 50,000 inhabitants.

TAKEAWAY:

• A total of 537 hospitals lost obstetric services between 2010 and 2022, with 238 rural hospitals and 299 urban hospitals affected, while only 138 hospitals gained obstetric services during this period.
• The percentage of hospitals without obstetrics increased steadily from 35.2% to 42.4% of all hospitals between 2010 and 2022, with rural hospitals consistently showing higher rates than urban facilities.
• By 2022, more than half (52.4%) of rural hospitals and over one third (35.7%) of urban hospitals did not offer obstetric care, representing a significant decline in access to maternal healthcare services.
• Urban areas showed greater potential for service recovery with 112 hospitals gaining obstetric services than only 26 rural hospitals during the study period.

IN PRACTICE:

“Access to obstetric care is an important determinant of maternal and infant health outcomes, and amidst a maternal health crisis in the US, hospital-based obstetric care has declined in both rural and urban communities,” wrote the authors of the study.

SOURCE:

The study was led by Katy B. Kozhimannil, PhD, MPA, Division of Health Policy and Management, University of Minnesota School of Public Health in Minneapolis. It was published online on December 4 in JAMA.

LIMITATIONS: 

The study was limited by the lack of data on births outside hospital settings, which represent less than 2% of United States births. Additionally, the denominator for the study outcome declined each year because of hospital closures, particularly affecting rural hospitals. The researchers also noted that while rurality exists on a continuum, they applied a dichotomous county–based measure of hospital location. Furthermore, the hospital-level data did not contain patient-level information, making it impossible to analyze how changes in obstetric status affected patient outcomes. 

DISCLOSURES:

This study was supported by the Federal Office of Rural Health Policy, Health Resources and Services Administration, Department of Health & Human Services under Public Health Service Cooperative Agreement. One coauthor disclosed receiving grants from the Laura and John Arnold Foundation, Ballad Health, and the Commonwealth Fund outside the submitted work. A coauthor reported receiving personal fees from the American Institute of Biological Sciences on behalf of March of Dimes as a grant reviewer. Another coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Between 2010 and 2022, hospital-based obstetric care declined significantly across the United States, with 52.4% of rural hospitals and 35.7% of urban hospitals not offering obstetric services by 2022. Rural hospitals experienced a steeper increase in the percentage of facilities without obstetrics than urban counterparts, despite several national maternity care access initiatives.

METHODOLOGY:

• Researchers conducted a retrospective cohort study of 4964 United States short-term acute care hospitals, including 1982 in rural counties and 2982 in urban counties, analyzing data from 2010 to 2022.
• Analysis utilized American Hospital Association annual surveys and Centers for Medicare & Medicaid Services Provider of Services files, applying an enhanced algorithm to identify hospital-based obstetric services availability.
• Hospital rurality classification followed Office of Management and Budget definitions, with urban hospitals located in metropolitan statistical areas having > 250,000 inhabitants and rural hospitals in nonmetropolitan areas with < 50,000 inhabitants.

TAKEAWAY:

• A total of 537 hospitals lost obstetric services between 2010 and 2022, with 238 rural hospitals and 299 urban hospitals affected, while only 138 hospitals gained obstetric services during this period.
• The percentage of hospitals without obstetrics increased steadily from 35.2% to 42.4% of all hospitals between 2010 and 2022, with rural hospitals consistently showing higher rates than urban facilities.
• By 2022, more than half (52.4%) of rural hospitals and over one third (35.7%) of urban hospitals did not offer obstetric care, representing a significant decline in access to maternal healthcare services.
• Urban areas showed greater potential for service recovery with 112 hospitals gaining obstetric services than only 26 rural hospitals during the study period.

IN PRACTICE:

“Access to obstetric care is an important determinant of maternal and infant health outcomes, and amidst a maternal health crisis in the US, hospital-based obstetric care has declined in both rural and urban communities,” wrote the authors of the study.

SOURCE:

The study was led by Katy B. Kozhimannil, PhD, MPA, Division of Health Policy and Management, University of Minnesota School of Public Health in Minneapolis. It was published online on December 4 in JAMA.

LIMITATIONS: 

The study was limited by the lack of data on births outside hospital settings, which represent less than 2% of United States births. Additionally, the denominator for the study outcome declined each year because of hospital closures, particularly affecting rural hospitals. The researchers also noted that while rurality exists on a continuum, they applied a dichotomous county–based measure of hospital location. Furthermore, the hospital-level data did not contain patient-level information, making it impossible to analyze how changes in obstetric status affected patient outcomes. 

DISCLOSURES:

This study was supported by the Federal Office of Rural Health Policy, Health Resources and Services Administration, Department of Health & Human Services under Public Health Service Cooperative Agreement. One coauthor disclosed receiving grants from the Laura and John Arnold Foundation, Ballad Health, and the Commonwealth Fund outside the submitted work. A coauthor reported receiving personal fees from the American Institute of Biological Sciences on behalf of March of Dimes as a grant reviewer. Another coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Digital lifestyle coaching through the Smarter Pregnancy program reduces maternal blood pressure (BP) by approximately 2 mm Hg during the first trimester of pregnancy. The program enhances lifestyle behaviors through personalized coaching on vegetable and fruit intake, smoking cessation, and alcohol abstinence.

METHODOLOGY:

• Researchers analyzed data from the Rotterdam Periconception Cohort between 2010 and 2019, including 132 pregnant women who used Smarter Pregnancy for 6-24 weeks in the intervention group and 1091 pregnant women in the control group.
• Participants’ outcomes included changes in systolic, diastolic, and mean arterial BPs between baseline and first trimester measurements, with median gestational age of 7 weeks at inclusion.
• Analysis tracked lifestyle behaviors in the intervention group at 12 and 24 weeks using risk scores for vegetables, fruits, smoking, and alcohol consumption.
• Multivariable analysis adjusted for baseline BP measurements, age, gestational age, geographic origin, parity, and conception mode to evaluate program effectiveness.

TAKEAWAY:

• The intervention group demonstrated significant reductions in systolic (beta, −2.34 mm Hg; 95% CI, −4.67 to −0.01; P = .049), diastolic (beta, −2.00 mm Hg; 95% CI, −3.57 to −0.45; P = .012), and mean arterial BP (beta, −2.22 mm Hg; 95% CI, −3.81 to −0.52; P = .011) compared with controls.
• Among women who underwent assisted reproductive technology (ART), significant reductions were observed in diastolic (beta, −2.38 mm Hg; 95% CI, −4.20 to −0.56) and mean arterial BP (beta, −2.63 mm Hg; 95% CI, −4.61 to −0.56).
• Program usage was associated with decreased lifestyle risk scores at 12 weeks (beta, −0.84; 95% CI, −1.19 to −0.49) and 24 weeks (beta, −1.07; 95% CI, −1.44 to −0.69), indicating improved lifestyle behaviors.
• Lifestyle risk scores significantly decreased in both ART and natural pregnancy subgroups after program completion.

IN PRACTICE:

“The findings suggest that Smarter Pregnancy can be used to coach women on healthy lifestyle behaviors commencing from the preconception period onwards to improve BP outcomes. Of note, although implementing the program during [the] first trimester seems easier, initiating lifestyle coaching as early as preconceptional period can act as preventive measure against adverse health outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Batoul Hojeij, PhD, Erasmus University Medical Center in Rotterdam, the Netherlands. It was published online in the American Journal of Preventive Medicine.

LIMITATIONS:

According to the authors, participants in the intervention group might have had healthier lifestyles due to their motivation to use a digital coaching program. The sample size of naturally conceived pregnancies in the intervention group was small (n = 41), reducing statistical power for subgroup analysis. The high percentage of missing data for baseline BP measurements (64%) could have affected statistical power and led to potential bias, though multiple imputations were used to address this limitation.

DISCLOSURES:

This study was supported by the European Union’s Horizon 2020 research and innovation program (DohART-NET) and the Department of Obstetrics and Gynaecology of the Erasmus MC. Kevin D Sinclair, PhD, DSc, received funding from the Biotechnology and Biological Sciences Research Council.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Digital lifestyle coaching through the Smarter Pregnancy program reduces maternal blood pressure (BP) by approximately 2 mm Hg during the first trimester of pregnancy. The program enhances lifestyle behaviors through personalized coaching on vegetable and fruit intake, smoking cessation, and alcohol abstinence.

METHODOLOGY:

• Researchers analyzed data from the Rotterdam Periconception Cohort between 2010 and 2019, including 132 pregnant women who used Smarter Pregnancy for 6-24 weeks in the intervention group and 1091 pregnant women in the control group.
• Participants’ outcomes included changes in systolic, diastolic, and mean arterial BPs between baseline and first trimester measurements, with median gestational age of 7 weeks at inclusion.
• Analysis tracked lifestyle behaviors in the intervention group at 12 and 24 weeks using risk scores for vegetables, fruits, smoking, and alcohol consumption.
• Multivariable analysis adjusted for baseline BP measurements, age, gestational age, geographic origin, parity, and conception mode to evaluate program effectiveness.

TAKEAWAY:

• The intervention group demonstrated significant reductions in systolic (beta, −2.34 mm Hg; 95% CI, −4.67 to −0.01; P = .049), diastolic (beta, −2.00 mm Hg; 95% CI, −3.57 to −0.45; P = .012), and mean arterial BP (beta, −2.22 mm Hg; 95% CI, −3.81 to −0.52; P = .011) compared with controls.
• Among women who underwent assisted reproductive technology (ART), significant reductions were observed in diastolic (beta, −2.38 mm Hg; 95% CI, −4.20 to −0.56) and mean arterial BP (beta, −2.63 mm Hg; 95% CI, −4.61 to −0.56).
• Program usage was associated with decreased lifestyle risk scores at 12 weeks (beta, −0.84; 95% CI, −1.19 to −0.49) and 24 weeks (beta, −1.07; 95% CI, −1.44 to −0.69), indicating improved lifestyle behaviors.
• Lifestyle risk scores significantly decreased in both ART and natural pregnancy subgroups after program completion.

IN PRACTICE:

“The findings suggest that Smarter Pregnancy can be used to coach women on healthy lifestyle behaviors commencing from the preconception period onwards to improve BP outcomes. Of note, although implementing the program during [the] first trimester seems easier, initiating lifestyle coaching as early as preconceptional period can act as preventive measure against adverse health outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Batoul Hojeij, PhD, Erasmus University Medical Center in Rotterdam, the Netherlands. It was published online in the American Journal of Preventive Medicine.

LIMITATIONS:

According to the authors, participants in the intervention group might have had healthier lifestyles due to their motivation to use a digital coaching program. The sample size of naturally conceived pregnancies in the intervention group was small (n = 41), reducing statistical power for subgroup analysis. The high percentage of missing data for baseline BP measurements (64%) could have affected statistical power and led to potential bias, though multiple imputations were used to address this limitation.

DISCLOSURES:

This study was supported by the European Union’s Horizon 2020 research and innovation program (DohART-NET) and the Department of Obstetrics and Gynaecology of the Erasmus MC. Kevin D Sinclair, PhD, DSc, received funding from the Biotechnology and Biological Sciences Research Council.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Digital lifestyle coaching through the Smarter Pregnancy program reduces maternal blood pressure (BP) by approximately 2 mm Hg during the first trimester of pregnancy. The program enhances lifestyle behaviors through personalized coaching on vegetable and fruit intake, smoking cessation, and alcohol abstinence.

METHODOLOGY:

• Researchers analyzed data from the Rotterdam Periconception Cohort between 2010 and 2019, including 132 pregnant women who used Smarter Pregnancy for 6-24 weeks in the intervention group and 1091 pregnant women in the control group.
• Participants’ outcomes included changes in systolic, diastolic, and mean arterial BPs between baseline and first trimester measurements, with median gestational age of 7 weeks at inclusion.
• Analysis tracked lifestyle behaviors in the intervention group at 12 and 24 weeks using risk scores for vegetables, fruits, smoking, and alcohol consumption.
• Multivariable analysis adjusted for baseline BP measurements, age, gestational age, geographic origin, parity, and conception mode to evaluate program effectiveness.

TAKEAWAY:

• The intervention group demonstrated significant reductions in systolic (beta, −2.34 mm Hg; 95% CI, −4.67 to −0.01; P = .049), diastolic (beta, −2.00 mm Hg; 95% CI, −3.57 to −0.45; P = .012), and mean arterial BP (beta, −2.22 mm Hg; 95% CI, −3.81 to −0.52; P = .011) compared with controls.
• Among women who underwent assisted reproductive technology (ART), significant reductions were observed in diastolic (beta, −2.38 mm Hg; 95% CI, −4.20 to −0.56) and mean arterial BP (beta, −2.63 mm Hg; 95% CI, −4.61 to −0.56).
• Program usage was associated with decreased lifestyle risk scores at 12 weeks (beta, −0.84; 95% CI, −1.19 to −0.49) and 24 weeks (beta, −1.07; 95% CI, −1.44 to −0.69), indicating improved lifestyle behaviors.
• Lifestyle risk scores significantly decreased in both ART and natural pregnancy subgroups after program completion.

IN PRACTICE:

“The findings suggest that Smarter Pregnancy can be used to coach women on healthy lifestyle behaviors commencing from the preconception period onwards to improve BP outcomes. Of note, although implementing the program during [the] first trimester seems easier, initiating lifestyle coaching as early as preconceptional period can act as preventive measure against adverse health outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Batoul Hojeij, PhD, Erasmus University Medical Center in Rotterdam, the Netherlands. It was published online in the American Journal of Preventive Medicine.

LIMITATIONS:

According to the authors, participants in the intervention group might have had healthier lifestyles due to their motivation to use a digital coaching program. The sample size of naturally conceived pregnancies in the intervention group was small (n = 41), reducing statistical power for subgroup analysis. The high percentage of missing data for baseline BP measurements (64%) could have affected statistical power and led to potential bias, though multiple imputations were used to address this limitation.

DISCLOSURES:

This study was supported by the European Union’s Horizon 2020 research and innovation program (DohART-NET) and the Department of Obstetrics and Gynaecology of the Erasmus MC. Kevin D Sinclair, PhD, DSc, received funding from the Biotechnology and Biological Sciences Research Council.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.

So far, data supporting GLP-1 use in addiction are limited to preclinical studies, anecdotal evidence, a few cohort analyses, and randomized clinical trials. But the chatter among researchers and clinicians, not to mention patients, portends its promise. 

 

“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.

GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.

 

Clinical, Real-World Data Promising

Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).

At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.

Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.

Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.

However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.

 

Unclear Mechanisms, Multiple Theories

It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.

Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.

“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.

Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.

The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.

 

Behind Closed Doors

Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.

“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.

Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.

Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.

But self-reports about alcohol consumption are far more common.

A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.

Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.

Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.

Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.

“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.

There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.

“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.” 

Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.

Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.

Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.

So far, data supporting GLP-1 use in addiction are limited to preclinical studies, anecdotal evidence, a few cohort analyses, and randomized clinical trials. But the chatter among researchers and clinicians, not to mention patients, portends its promise. 

 

“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.

GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.

 

Clinical, Real-World Data Promising

Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).

At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.

Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.

Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.

However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.

 

Unclear Mechanisms, Multiple Theories

It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.

Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.

“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.

Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.

The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.

 

Behind Closed Doors

Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.

“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.

Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.

Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.

But self-reports about alcohol consumption are far more common.

A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.

Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.

Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.

Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.

“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.

There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.

“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.” 

Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.

Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.

Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.

So far, data supporting GLP-1 use in addiction are limited to preclinical studies, anecdotal evidence, a few cohort analyses, and randomized clinical trials. But the chatter among researchers and clinicians, not to mention patients, portends its promise. 

 

“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.

GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.

 

Clinical, Real-World Data Promising

Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).

At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.

Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.

Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.

However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.

 

Unclear Mechanisms, Multiple Theories

It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.

Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.

“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.

Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.

The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.

 

Behind Closed Doors

Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.

“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.

Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.

Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.

But self-reports about alcohol consumption are far more common.

A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.

Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.

Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.

Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.

“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.

There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.

“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.” 

Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.

Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.

Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.

A version of this article appeared on Medscape.com.

Endocrine disruptors (EDs) — chemicals in the environment that could affect human endocrine function — are increasingly becoming a prominent concern for the public as well as professionals. At its 40th congress, the French Society of Endocrinology hosted a public lecture on the subject, given by Nicolas Chevalier, MD, PhD, professor of endocrinology at the University Hospital of Nice in France.

Environmental EDs

Chevalier began by asking the audience to remember one number: 906. This is the number of substances identified by the French Agency for Food, Environmental and Occupational Health & Safety for which there are sufficient scientific data to confirm or at least suspect endocrine-disrupting activity. In reality, the number is likely closer to 10,000, he said.

These chemicals include bisphenol A and its substitutes, parabens, phthalates, and pesticides. Additionally, lithium (mainly found in batteries), polychlorinated biphenyls, per- and polyfluoroalkyl substances, and polybromodiphenyl ethers, or brominated flame retardants, are included. These products are found throughout our environment, so much so that Chevalier said: “We are swimming in a soup of endocrine disruptors.”

The main source of human contamination is food, responsible for an estimated 80%-90% of those encountered. They may enter the food supply during production or preservation, and pesticides are not the only culprits. For example, fatty fish contain heavy metals. Water is also a significant source of contamination. It is worth noting that tap water is the cleanest and most monitored type when it comes to EDs. However, plastic bottles leach not only EDs but also microplastics, which are a major environmental pollution source.

Many other features in our daily environment contain EDs: Clothing (especially shoes), nonstick cookware, plastic containers (especially those heated in the microwave), plastic toys (which young children often put in their mouths), and cosmetic products (makeup, which is increasingly used by young girls). The placenta is not the barrier it was once thought to be: Amniotic fluid has been found to contain about 35 molecules that are toxic for the fetus, with at least 11 or 12 exceeding safety thresholds.

 

Multiple Linked Diseases

An incomplete list of ED-related diseases would include cancer, infertility, obesity, and diabetes, Chevalier said. Are these data alarmist? he asked. After all, life expectancy has increased globally by more than 10 years since the 1970s, and this has occurred alongside the increased use of EDs. However, he suggested remembering a second number: 157. This represents the billions of euros in European healthcare costs primarily caused by neurologic disorders linked to pesticides. They have a half-life estimated at least 10 years, and banning them will not stop them from persisting in the environment for up to 40 years. US studies have shown that their presence in the environment contributes to cognitive delays in young children.

Another area of concern is the rising infertility rates among couples, now affecting around one in five in France. This trend has been linked to the toxicity of EDs on the genital tract, especially in men, and is not only related to increased use of birth control. For example, in sub-Saharan Africa, rates of contraceptive use have increased only marginally, but birth rates have significantly decreased in areas contaminated by waste that is inadequately managed by Western standards.

EDs have also been implicated in the rising incidence of several cancers, including breast cancer in women and prostate cancer in men, and may have contributed to increases in both childhood obesity and adult diabetes.

 

A Difficult Battle

Chevalier asked: Is the increase in ED contamination inevitable? No, he said, but it is extremely difficult to counter. Governments are reluctant to legislate, particularly when jobs are at stake, even though certain workers are particularly exposed. The ideal situation would be for the public to take matters into their own hands by eliminating EDs from their environment through daily actions that pressure policymakers to act. For example:

• Eliminate plastics (especially for food products) and nonstick coatings
• Reject most cleaning products in favor of traditional solutions (eg, white vinegar and baking soda)
• Avoid imported toys (as producer countries often fail to comply with European health standards)

Environmental charters have been created by several local authorities and regional health agencies. Chevalier urged the public to rely on their recommendations and resources to help drive change.

 

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Endocrine disruptors (EDs) — chemicals in the environment that could affect human endocrine function — are increasingly becoming a prominent concern for the public as well as professionals. At its 40th congress, the French Society of Endocrinology hosted a public lecture on the subject, given by Nicolas Chevalier, MD, PhD, professor of endocrinology at the University Hospital of Nice in France.

Environmental EDs

Chevalier began by asking the audience to remember one number: 906. This is the number of substances identified by the French Agency for Food, Environmental and Occupational Health & Safety for which there are sufficient scientific data to confirm or at least suspect endocrine-disrupting activity. In reality, the number is likely closer to 10,000, he said.

These chemicals include bisphenol A and its substitutes, parabens, phthalates, and pesticides. Additionally, lithium (mainly found in batteries), polychlorinated biphenyls, per- and polyfluoroalkyl substances, and polybromodiphenyl ethers, or brominated flame retardants, are included. These products are found throughout our environment, so much so that Chevalier said: “We are swimming in a soup of endocrine disruptors.”

The main source of human contamination is food, responsible for an estimated 80%-90% of those encountered. They may enter the food supply during production or preservation, and pesticides are not the only culprits. For example, fatty fish contain heavy metals. Water is also a significant source of contamination. It is worth noting that tap water is the cleanest and most monitored type when it comes to EDs. However, plastic bottles leach not only EDs but also microplastics, which are a major environmental pollution source.

Many other features in our daily environment contain EDs: Clothing (especially shoes), nonstick cookware, plastic containers (especially those heated in the microwave), plastic toys (which young children often put in their mouths), and cosmetic products (makeup, which is increasingly used by young girls). The placenta is not the barrier it was once thought to be: Amniotic fluid has been found to contain about 35 molecules that are toxic for the fetus, with at least 11 or 12 exceeding safety thresholds.

 

Multiple Linked Diseases

An incomplete list of ED-related diseases would include cancer, infertility, obesity, and diabetes, Chevalier said. Are these data alarmist? he asked. After all, life expectancy has increased globally by more than 10 years since the 1970s, and this has occurred alongside the increased use of EDs. However, he suggested remembering a second number: 157. This represents the billions of euros in European healthcare costs primarily caused by neurologic disorders linked to pesticides. They have a half-life estimated at least 10 years, and banning them will not stop them from persisting in the environment for up to 40 years. US studies have shown that their presence in the environment contributes to cognitive delays in young children.

Another area of concern is the rising infertility rates among couples, now affecting around one in five in France. This trend has been linked to the toxicity of EDs on the genital tract, especially in men, and is not only related to increased use of birth control. For example, in sub-Saharan Africa, rates of contraceptive use have increased only marginally, but birth rates have significantly decreased in areas contaminated by waste that is inadequately managed by Western standards.

EDs have also been implicated in the rising incidence of several cancers, including breast cancer in women and prostate cancer in men, and may have contributed to increases in both childhood obesity and adult diabetes.

 

A Difficult Battle

Chevalier asked: Is the increase in ED contamination inevitable? No, he said, but it is extremely difficult to counter. Governments are reluctant to legislate, particularly when jobs are at stake, even though certain workers are particularly exposed. The ideal situation would be for the public to take matters into their own hands by eliminating EDs from their environment through daily actions that pressure policymakers to act. For example:

• Eliminate plastics (especially for food products) and nonstick coatings
• Reject most cleaning products in favor of traditional solutions (eg, white vinegar and baking soda)
• Avoid imported toys (as producer countries often fail to comply with European health standards)

Environmental charters have been created by several local authorities and regional health agencies. Chevalier urged the public to rely on their recommendations and resources to help drive change.

 

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Endocrine disruptors (EDs) — chemicals in the environment that could affect human endocrine function — are increasingly becoming a prominent concern for the public as well as professionals. At its 40th congress, the French Society of Endocrinology hosted a public lecture on the subject, given by Nicolas Chevalier, MD, PhD, professor of endocrinology at the University Hospital of Nice in France.

Environmental EDs

Chevalier began by asking the audience to remember one number: 906. This is the number of substances identified by the French Agency for Food, Environmental and Occupational Health & Safety for which there are sufficient scientific data to confirm or at least suspect endocrine-disrupting activity. In reality, the number is likely closer to 10,000, he said.

These chemicals include bisphenol A and its substitutes, parabens, phthalates, and pesticides. Additionally, lithium (mainly found in batteries), polychlorinated biphenyls, per- and polyfluoroalkyl substances, and polybromodiphenyl ethers, or brominated flame retardants, are included. These products are found throughout our environment, so much so that Chevalier said: “We are swimming in a soup of endocrine disruptors.”

The main source of human contamination is food, responsible for an estimated 80%-90% of those encountered. They may enter the food supply during production or preservation, and pesticides are not the only culprits. For example, fatty fish contain heavy metals. Water is also a significant source of contamination. It is worth noting that tap water is the cleanest and most monitored type when it comes to EDs. However, plastic bottles leach not only EDs but also microplastics, which are a major environmental pollution source.

Many other features in our daily environment contain EDs: Clothing (especially shoes), nonstick cookware, plastic containers (especially those heated in the microwave), plastic toys (which young children often put in their mouths), and cosmetic products (makeup, which is increasingly used by young girls). The placenta is not the barrier it was once thought to be: Amniotic fluid has been found to contain about 35 molecules that are toxic for the fetus, with at least 11 or 12 exceeding safety thresholds.

 

Multiple Linked Diseases

An incomplete list of ED-related diseases would include cancer, infertility, obesity, and diabetes, Chevalier said. Are these data alarmist? he asked. After all, life expectancy has increased globally by more than 10 years since the 1970s, and this has occurred alongside the increased use of EDs. However, he suggested remembering a second number: 157. This represents the billions of euros in European healthcare costs primarily caused by neurologic disorders linked to pesticides. They have a half-life estimated at least 10 years, and banning them will not stop them from persisting in the environment for up to 40 years. US studies have shown that their presence in the environment contributes to cognitive delays in young children.

Another area of concern is the rising infertility rates among couples, now affecting around one in five in France. This trend has been linked to the toxicity of EDs on the genital tract, especially in men, and is not only related to increased use of birth control. For example, in sub-Saharan Africa, rates of contraceptive use have increased only marginally, but birth rates have significantly decreased in areas contaminated by waste that is inadequately managed by Western standards.

EDs have also been implicated in the rising incidence of several cancers, including breast cancer in women and prostate cancer in men, and may have contributed to increases in both childhood obesity and adult diabetes.

 

A Difficult Battle

Chevalier asked: Is the increase in ED contamination inevitable? No, he said, but it is extremely difficult to counter. Governments are reluctant to legislate, particularly when jobs are at stake, even though certain workers are particularly exposed. The ideal situation would be for the public to take matters into their own hands by eliminating EDs from their environment through daily actions that pressure policymakers to act. For example:

• Eliminate plastics (especially for food products) and nonstick coatings
• Reject most cleaning products in favor of traditional solutions (eg, white vinegar and baking soda)
• Avoid imported toys (as producer countries often fail to comply with European health standards)

Environmental charters have been created by several local authorities and regional health agencies. Chevalier urged the public to rely on their recommendations and resources to help drive change.

 

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Veterans receiving blood pressure (BP) medication as needed while hospitalized were at a 23% higher risk for acute kidney injury (AKI) and a 1.5-fold greater risk for potentially dangerous rapid reductions in BP.

METHODOLOGY:

• Researchers analyzed the records of 133,760 veterans (90% men; mean age, 71.2 years) hospitalized in Veterans Affairs hospitals between 2015 and 2020.
• The study analyzed as-needed administration of BP drugs to patients who had an elevated BP but were asymptomatic.
• Patients who had at least one systolic BP reading above 140 mm Hg and received scheduled BP medication in the first 24 hours of hospitalization were included; those admitted to intensive care units or those who required surgery were excluded.
• The analysis compared outcomes between 28,526 patients who received as-needed drugs and 105,234 who did not; the primary outcome was time to the first AKI occurrence while hospitalized.
• Secondary outcomes included a reduction of more than 25% in systolic BP within 3 hours of as-needed BP medication, as well as a composite outcome of myocardial infarction, stroke, or death during hospitalization.

TAKEAWAY:

• Researchers found that an AKI was 23% more likely to occur in veterans who received at least one as-needed BP medication (hazard ratio [HR], 1.23; 95% CI, 1.18-1.29).
• Veterans who received BP medication as needed were 50% more likely to experience a rapid drop in BP within 3 hours (HR, 1.50; 95% CI, 1.39-1.62) and more than twice as likely after 1 hour (HR, 2.11; 95% CI, 1.81-2.46) than those who did not receive medication.
• The risk of experiencing the composite outcome was 69% times higher in the as-needed group (rate ratio [RR], 1.69; 95% CI, 1.49-1.92), with individual increased risks for myocardial infarction (RR, 2.92; 95% CI, 2.09-4.07), stroke (RR, 1.99; 95% CI, 1.30-3.03), and death (RR, 1.52; 95% CI, 1.32-1.75).

IN PRACTICE:

“The practical implication of our findings is that there is at least equipoise regarding the utility of as-needed BP medication use for asymptomatic BP elevations in hospitals ... future prospective trials should evaluate the risks and benefits of this common practice,” the study authors wrote.

SOURCE:

The study was led by Muna Thalji Canales, MD, MS, of the North Florida/South Georgia Veterans Health System in Gainesville, Florida. It was published online on November 25 in JAMA Internal Medicine.

LIMITATIONS:

The analysis may have included confounding factors that could have influenced results. The focus on veterans who had not undergone surgery limits generalizability to women, surgical patients, and nonveteran populations. The researchers noted limited data on factors that might influence BP readings in the hospital such as pain, stress, and faulty machinery.

DISCLOSURES:

Study authors reported grants and consulting fees from Merck Sharp & Dohme and BMS, and Teva Pharmaceuticals, among others.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Veterans receiving blood pressure (BP) medication as needed while hospitalized were at a 23% higher risk for acute kidney injury (AKI) and a 1.5-fold greater risk for potentially dangerous rapid reductions in BP.

METHODOLOGY:

• Researchers analyzed the records of 133,760 veterans (90% men; mean age, 71.2 years) hospitalized in Veterans Affairs hospitals between 2015 and 2020.
• The study analyzed as-needed administration of BP drugs to patients who had an elevated BP but were asymptomatic.
• Patients who had at least one systolic BP reading above 140 mm Hg and received scheduled BP medication in the first 24 hours of hospitalization were included; those admitted to intensive care units or those who required surgery were excluded.
• The analysis compared outcomes between 28,526 patients who received as-needed drugs and 105,234 who did not; the primary outcome was time to the first AKI occurrence while hospitalized.
• Secondary outcomes included a reduction of more than 25% in systolic BP within 3 hours of as-needed BP medication, as well as a composite outcome of myocardial infarction, stroke, or death during hospitalization.

TAKEAWAY:

• Researchers found that an AKI was 23% more likely to occur in veterans who received at least one as-needed BP medication (hazard ratio [HR], 1.23; 95% CI, 1.18-1.29).
• Veterans who received BP medication as needed were 50% more likely to experience a rapid drop in BP within 3 hours (HR, 1.50; 95% CI, 1.39-1.62) and more than twice as likely after 1 hour (HR, 2.11; 95% CI, 1.81-2.46) than those who did not receive medication.
• The risk of experiencing the composite outcome was 69% times higher in the as-needed group (rate ratio [RR], 1.69; 95% CI, 1.49-1.92), with individual increased risks for myocardial infarction (RR, 2.92; 95% CI, 2.09-4.07), stroke (RR, 1.99; 95% CI, 1.30-3.03), and death (RR, 1.52; 95% CI, 1.32-1.75).

IN PRACTICE:

“The practical implication of our findings is that there is at least equipoise regarding the utility of as-needed BP medication use for asymptomatic BP elevations in hospitals ... future prospective trials should evaluate the risks and benefits of this common practice,” the study authors wrote.

SOURCE:

The study was led by Muna Thalji Canales, MD, MS, of the North Florida/South Georgia Veterans Health System in Gainesville, Florida. It was published online on November 25 in JAMA Internal Medicine.

LIMITATIONS:

The analysis may have included confounding factors that could have influenced results. The focus on veterans who had not undergone surgery limits generalizability to women, surgical patients, and nonveteran populations. The researchers noted limited data on factors that might influence BP readings in the hospital such as pain, stress, and faulty machinery.

DISCLOSURES:

Study authors reported grants and consulting fees from Merck Sharp & Dohme and BMS, and Teva Pharmaceuticals, among others.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Veterans receiving blood pressure (BP) medication as needed while hospitalized were at a 23% higher risk for acute kidney injury (AKI) and a 1.5-fold greater risk for potentially dangerous rapid reductions in BP.

METHODOLOGY:

• Researchers analyzed the records of 133,760 veterans (90% men; mean age, 71.2 years) hospitalized in Veterans Affairs hospitals between 2015 and 2020.
• The study analyzed as-needed administration of BP drugs to patients who had an elevated BP but were asymptomatic.
• Patients who had at least one systolic BP reading above 140 mm Hg and received scheduled BP medication in the first 24 hours of hospitalization were included; those admitted to intensive care units or those who required surgery were excluded.
• The analysis compared outcomes between 28,526 patients who received as-needed drugs and 105,234 who did not; the primary outcome was time to the first AKI occurrence while hospitalized.
• Secondary outcomes included a reduction of more than 25% in systolic BP within 3 hours of as-needed BP medication, as well as a composite outcome of myocardial infarction, stroke, or death during hospitalization.

TAKEAWAY:

• Researchers found that an AKI was 23% more likely to occur in veterans who received at least one as-needed BP medication (hazard ratio [HR], 1.23; 95% CI, 1.18-1.29).
• Veterans who received BP medication as needed were 50% more likely to experience a rapid drop in BP within 3 hours (HR, 1.50; 95% CI, 1.39-1.62) and more than twice as likely after 1 hour (HR, 2.11; 95% CI, 1.81-2.46) than those who did not receive medication.
• The risk of experiencing the composite outcome was 69% times higher in the as-needed group (rate ratio [RR], 1.69; 95% CI, 1.49-1.92), with individual increased risks for myocardial infarction (RR, 2.92; 95% CI, 2.09-4.07), stroke (RR, 1.99; 95% CI, 1.30-3.03), and death (RR, 1.52; 95% CI, 1.32-1.75).

IN PRACTICE:

“The practical implication of our findings is that there is at least equipoise regarding the utility of as-needed BP medication use for asymptomatic BP elevations in hospitals ... future prospective trials should evaluate the risks and benefits of this common practice,” the study authors wrote.

SOURCE:

The study was led by Muna Thalji Canales, MD, MS, of the North Florida/South Georgia Veterans Health System in Gainesville, Florida. It was published online on November 25 in JAMA Internal Medicine.

LIMITATIONS:

The analysis may have included confounding factors that could have influenced results. The focus on veterans who had not undergone surgery limits generalizability to women, surgical patients, and nonveteran populations. The researchers noted limited data on factors that might influence BP readings in the hospital such as pain, stress, and faulty machinery.

DISCLOSURES:

Study authors reported grants and consulting fees from Merck Sharp & Dohme and BMS, and Teva Pharmaceuticals, among others.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



MAKE A GIFT TODAY

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



MAKE A GIFT TODAY

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



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