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Gabapentin: The Hope, the Harm, the Myth, the Reality
Since gabapentin was approved by the US Food and Drug Administration (FDA) for treatment of partial-onset seizures and postherpetic neuralgia, it has been used in many different ways, many off-label indications, and with several recent safety warnings.
Early Problems
After FDA approval in 1993 (for partial seizures), gabapentin was promoted by its maker (Park-Davis) for off-label indications, especially for pain. There was no FDA approval for that indication and the studies the company had done were deemed to have been manipulated in a subsequent lawsuit.1 Gabapentin became the nonopioid go-to medication for treatment of pain despite underwhelming evidence.
Studies on Neuropathy
In the largest trial of gabapentin for diabetic peripheral neuropathy, Rauck and colleagues found no significant difference in pain relief between gabapentin and placebo.2 A Cochrane review of gabapentin for neuropathic pain concluded that about 30%-40% of patients taking gabapentin for diabetic neuropathy achieved meaningful pain relief with gabapentin use, with a number needed to treat (NNT) of 6.6.3 The review also concluded that for postherpetic neuralgia (an FDA-approved indication) 78% of patients had moderate to substantial benefit with gabapentin (NNT 4.8 for moderate benefit).
Side Effects of Gabapentin
From the Cochrane review, the most common side effects were: dizziness (19%), somnolence (14%), peripheral edema (7%), and gait disturbance (14%). The number needed to harm for gabapentin was 7.5 The two side effects listed here that are often overlooked that I want to highlight are peripheral edema and gait disturbance. I have seen these both fairly frequently over the years. A side effect not found in the Cochrane review was weight gain. Weight gain with gabapentin was reported in a meta-analysis of drugs that can cause weight gain.4
New Warnings
In December 2019, the FDA released a warning on the potential for serious respiratory problems with gabapentin and pregabalin in patients with certain risk factors: opioid use or use of other drugs that depress the central nervous system, COPD, and other severe lung diseases.5 Rahman and colleagues found that compared with nonuse, gabapentinoid use was associated with increased risk for severe COPD exacerbation (hazard ratio, 1.39; 95% confidence interval, 1.29-1.50).6
Off-Label Uses
Primary care professionals frequently use gabapentin for two off-label indications that are incorporated into practice guidelines. Ryan et al. studied gabapentin in patients with refractory, unexplained chronic cough.7 In a randomized, placebo-controlled trial, gabapentin improved cough-specific quality of life compared with placebo (P = .004; NNT 3.58). Use of gabapentin for treatment of unexplained, refractory cough has been included in several chronic cough practice guidelines.8,9
Gabapentin has been studied for the treatment of restless legs syndrome and has been recommended as an option to treat moderate to severe restless legs syndrome in the American Academy of Sleep Medicine Guidelines.10
Pearl of the Month:
Gabapentin is used widely for many different pain syndromes. The best evidence is for postherpetic neuralgia and diabetic neuropathy. Be aware of the side effects and risks of use in patients with pulmonary disease and who are taking CNS-depressant medications.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Landefeld CS, Steinman MA. The Neurontin legacy: marketing through misinformation and manipulation. N Engl J Med. 2009;360(2):103-6.
2. Rauck R et al. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013;13(6):485-96.
3. Wiffen PJ et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6(6):CD007938.
4. Domecq JP et al. Clinical review: Drugs commonly associated with weight change: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2015 Feb;100(2):363-70.
5. 12-19-2019 FDA Drug Safety Communication. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).
6. Rahman AA et al. Gabapentinoids and risk for severe exacerbation in chronic obstructive pulmonary disease: A population-based cohort study. Ann Intern Med. 2024 Feb;177(2):144-54.
7. Ryan NM et al. Gabapentin for refractory chronic cough: a randomised, double-blind, placebo-controlled trial. Lancet 2012;380(9853):1583-9.
8. Gibson P et al. Treatment of unexplained chronic cough: CHEST guideline and expert panel report. Chest. 2016 Jan;149(1):27-44.
9. De Vincentis A et al. Chronic cough in adults: recommendations from an Italian intersociety consensus. Aging Clin Exp Res 2022;34:1529.
10. Aurora RN et al. The treatment of restless legs syndrome and periodic limb movement disorder in adults — an update for 2012: Practice parameters with an evidence-based systematic review and meta-analyses: An American Academy of Sleep Medicine Clinical Practice Guideline. Sleep 2012;35:1039.
Since gabapentin was approved by the US Food and Drug Administration (FDA) for treatment of partial-onset seizures and postherpetic neuralgia, it has been used in many different ways, many off-label indications, and with several recent safety warnings.
Early Problems
After FDA approval in 1993 (for partial seizures), gabapentin was promoted by its maker (Park-Davis) for off-label indications, especially for pain. There was no FDA approval for that indication and the studies the company had done were deemed to have been manipulated in a subsequent lawsuit.1 Gabapentin became the nonopioid go-to medication for treatment of pain despite underwhelming evidence.
Studies on Neuropathy
In the largest trial of gabapentin for diabetic peripheral neuropathy, Rauck and colleagues found no significant difference in pain relief between gabapentin and placebo.2 A Cochrane review of gabapentin for neuropathic pain concluded that about 30%-40% of patients taking gabapentin for diabetic neuropathy achieved meaningful pain relief with gabapentin use, with a number needed to treat (NNT) of 6.6.3 The review also concluded that for postherpetic neuralgia (an FDA-approved indication) 78% of patients had moderate to substantial benefit with gabapentin (NNT 4.8 for moderate benefit).
Side Effects of Gabapentin
From the Cochrane review, the most common side effects were: dizziness (19%), somnolence (14%), peripheral edema (7%), and gait disturbance (14%). The number needed to harm for gabapentin was 7.5 The two side effects listed here that are often overlooked that I want to highlight are peripheral edema and gait disturbance. I have seen these both fairly frequently over the years. A side effect not found in the Cochrane review was weight gain. Weight gain with gabapentin was reported in a meta-analysis of drugs that can cause weight gain.4
New Warnings
In December 2019, the FDA released a warning on the potential for serious respiratory problems with gabapentin and pregabalin in patients with certain risk factors: opioid use or use of other drugs that depress the central nervous system, COPD, and other severe lung diseases.5 Rahman and colleagues found that compared with nonuse, gabapentinoid use was associated with increased risk for severe COPD exacerbation (hazard ratio, 1.39; 95% confidence interval, 1.29-1.50).6
Off-Label Uses
Primary care professionals frequently use gabapentin for two off-label indications that are incorporated into practice guidelines. Ryan et al. studied gabapentin in patients with refractory, unexplained chronic cough.7 In a randomized, placebo-controlled trial, gabapentin improved cough-specific quality of life compared with placebo (P = .004; NNT 3.58). Use of gabapentin for treatment of unexplained, refractory cough has been included in several chronic cough practice guidelines.8,9
Gabapentin has been studied for the treatment of restless legs syndrome and has been recommended as an option to treat moderate to severe restless legs syndrome in the American Academy of Sleep Medicine Guidelines.10
Pearl of the Month:
Gabapentin is used widely for many different pain syndromes. The best evidence is for postherpetic neuralgia and diabetic neuropathy. Be aware of the side effects and risks of use in patients with pulmonary disease and who are taking CNS-depressant medications.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Landefeld CS, Steinman MA. The Neurontin legacy: marketing through misinformation and manipulation. N Engl J Med. 2009;360(2):103-6.
2. Rauck R et al. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013;13(6):485-96.
3. Wiffen PJ et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6(6):CD007938.
4. Domecq JP et al. Clinical review: Drugs commonly associated with weight change: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2015 Feb;100(2):363-70.
5. 12-19-2019 FDA Drug Safety Communication. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).
6. Rahman AA et al. Gabapentinoids and risk for severe exacerbation in chronic obstructive pulmonary disease: A population-based cohort study. Ann Intern Med. 2024 Feb;177(2):144-54.
7. Ryan NM et al. Gabapentin for refractory chronic cough: a randomised, double-blind, placebo-controlled trial. Lancet 2012;380(9853):1583-9.
8. Gibson P et al. Treatment of unexplained chronic cough: CHEST guideline and expert panel report. Chest. 2016 Jan;149(1):27-44.
9. De Vincentis A et al. Chronic cough in adults: recommendations from an Italian intersociety consensus. Aging Clin Exp Res 2022;34:1529.
10. Aurora RN et al. The treatment of restless legs syndrome and periodic limb movement disorder in adults — an update for 2012: Practice parameters with an evidence-based systematic review and meta-analyses: An American Academy of Sleep Medicine Clinical Practice Guideline. Sleep 2012;35:1039.
Since gabapentin was approved by the US Food and Drug Administration (FDA) for treatment of partial-onset seizures and postherpetic neuralgia, it has been used in many different ways, many off-label indications, and with several recent safety warnings.
Early Problems
After FDA approval in 1993 (for partial seizures), gabapentin was promoted by its maker (Park-Davis) for off-label indications, especially for pain. There was no FDA approval for that indication and the studies the company had done were deemed to have been manipulated in a subsequent lawsuit.1 Gabapentin became the nonopioid go-to medication for treatment of pain despite underwhelming evidence.
Studies on Neuropathy
In the largest trial of gabapentin for diabetic peripheral neuropathy, Rauck and colleagues found no significant difference in pain relief between gabapentin and placebo.2 A Cochrane review of gabapentin for neuropathic pain concluded that about 30%-40% of patients taking gabapentin for diabetic neuropathy achieved meaningful pain relief with gabapentin use, with a number needed to treat (NNT) of 6.6.3 The review also concluded that for postherpetic neuralgia (an FDA-approved indication) 78% of patients had moderate to substantial benefit with gabapentin (NNT 4.8 for moderate benefit).
Side Effects of Gabapentin
From the Cochrane review, the most common side effects were: dizziness (19%), somnolence (14%), peripheral edema (7%), and gait disturbance (14%). The number needed to harm for gabapentin was 7.5 The two side effects listed here that are often overlooked that I want to highlight are peripheral edema and gait disturbance. I have seen these both fairly frequently over the years. A side effect not found in the Cochrane review was weight gain. Weight gain with gabapentin was reported in a meta-analysis of drugs that can cause weight gain.4
New Warnings
In December 2019, the FDA released a warning on the potential for serious respiratory problems with gabapentin and pregabalin in patients with certain risk factors: opioid use or use of other drugs that depress the central nervous system, COPD, and other severe lung diseases.5 Rahman and colleagues found that compared with nonuse, gabapentinoid use was associated with increased risk for severe COPD exacerbation (hazard ratio, 1.39; 95% confidence interval, 1.29-1.50).6
Off-Label Uses
Primary care professionals frequently use gabapentin for two off-label indications that are incorporated into practice guidelines. Ryan et al. studied gabapentin in patients with refractory, unexplained chronic cough.7 In a randomized, placebo-controlled trial, gabapentin improved cough-specific quality of life compared with placebo (P = .004; NNT 3.58). Use of gabapentin for treatment of unexplained, refractory cough has been included in several chronic cough practice guidelines.8,9
Gabapentin has been studied for the treatment of restless legs syndrome and has been recommended as an option to treat moderate to severe restless legs syndrome in the American Academy of Sleep Medicine Guidelines.10
Pearl of the Month:
Gabapentin is used widely for many different pain syndromes. The best evidence is for postherpetic neuralgia and diabetic neuropathy. Be aware of the side effects and risks of use in patients with pulmonary disease and who are taking CNS-depressant medications.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Landefeld CS, Steinman MA. The Neurontin legacy: marketing through misinformation and manipulation. N Engl J Med. 2009;360(2):103-6.
2. Rauck R et al. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013;13(6):485-96.
3. Wiffen PJ et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6(6):CD007938.
4. Domecq JP et al. Clinical review: Drugs commonly associated with weight change: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2015 Feb;100(2):363-70.
5. 12-19-2019 FDA Drug Safety Communication. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).
6. Rahman AA et al. Gabapentinoids and risk for severe exacerbation in chronic obstructive pulmonary disease: A population-based cohort study. Ann Intern Med. 2024 Feb;177(2):144-54.
7. Ryan NM et al. Gabapentin for refractory chronic cough: a randomised, double-blind, placebo-controlled trial. Lancet 2012;380(9853):1583-9.
8. Gibson P et al. Treatment of unexplained chronic cough: CHEST guideline and expert panel report. Chest. 2016 Jan;149(1):27-44.
9. De Vincentis A et al. Chronic cough in adults: recommendations from an Italian intersociety consensus. Aging Clin Exp Res 2022;34:1529.
10. Aurora RN et al. The treatment of restless legs syndrome and periodic limb movement disorder in adults — an update for 2012: Practice parameters with an evidence-based systematic review and meta-analyses: An American Academy of Sleep Medicine Clinical Practice Guideline. Sleep 2012;35:1039.
Just A Single Night of Poor Sleep May Change Serum Proteins
wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.
In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.
The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.
Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.
The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.
“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
Too Soon for Clinical Implications
“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.
“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.
However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.
The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.
A version of this article first appeared on Medscape.com.
wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.
In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.
The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.
Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.
The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.
“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
Too Soon for Clinical Implications
“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.
“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.
However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.
The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.
A version of this article first appeared on Medscape.com.
wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.
In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.
The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.
Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.
The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.
“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
Too Soon for Clinical Implications
“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.
“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.
However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.
The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM SLEEP ADVANCES
Wildfire Pollution May Increase Asthma Hospitalizations
Short-term increases in fine particulate matter (PM2.5) resulting from wildfire smoke are becoming a greater global problem and have been associated with poor asthma and COPD outcomes, wrote Benjamin D. Horne, PhD, of the Intermountain Medical Center Heart Institute, Salt Lake City, Utah, and colleagues. However, the effect of short-term increases in PM2.5 on hospitalizations for asthma and COPD has not been well studied, they noted.
“Our primary reason for studying the association of air pollution in the summer/fall wildfire season separately from the winter is that the drought conditions in the western United States from 2012-2022 resulted in more wildfires and increasingly large wildfires across the west,” Dr. Horne said in an interview. “In part, this provided a chance to measure an increase of fine particulate matter (PM2.5) air pollution from wildfires and also to track what happened to their health when people were exposed to the PM2.5 from wildfire,” he said.
During 2020-2022, the PM2.5 produced during the wildfire season exceeded the PM2.5 levels measured in the winter for the first time, Dr. Horne said. In the part of Utah where the study was conducted, PM2.5 increases in winter because of a combination of concentrated PM2.5 from cars and industry and a weather phenomenon known as a temperature inversion, he said.
A temperature inversion occurs when mountain topography traps pollutants near the ground where the people are, but only during times of cold and snowy weather, Dr. Horne said.
“Past studies in the region were conducted with the assumption that the winter inversion was the primary source of pollution-related health risks, and public and healthcare guidance for health was based on avoiding winter air pollution,” Dr. Horne noted. However, “it may be that the smoke from wildfires requires people to also anticipate how to avoid exposure to PM2.5 during the summer,” he said.
In a study published in CHEST Pulmonary, the researchers reviewed data from 63,976 patients hospitalized with asthma and 18,514 hospitalized with COPD between January 1999 and March 2022 who lived in an area of Utah in which PM2.5 and ozone are measured by the Environmental Protection Agency. The average age of the asthma patients was 22.6 years; 51.0% were women, 16.0% had hypertension, and 10.1% had a history of smoking. The average age of the COPD patients was 63.5 years, 50.3% were women, 69.1% had hypertension, and 42.3% had a history of smoking.
In a regression analysis, the risk for asthma was significantly associated with days of increased PM2.5 during wildfire season and similar to the winter inversion (when cold air traps air pollutants), with odds ratios (ORs) of 1.057 and 1.023 for every 10 µg per m3 of particulate matter, respectively.
Although the risk for asthma hospitalization decreased after a week, a rebound occurred during wildfire season after a 4-week lag, with an OR of 1.098 for every 10 µg per m3 of particulate matter, the researchers wrote. A review of all months showed a significant association between a concurrent day increase in PM2.5 and asthma hospitalization (OR, 1.020 per every 10 µg per m3 of particulate matter, P = .0006).
By contrast, PM2.5 increases had only a weak association with hospitalizations for COPD during either wildfire season or winter inversion season, and ozone was not associated with increased risks for patients with asthma or COPD.
The findings were limited by several factors including the observational design, potential for confounding, and relatively homogeneous study population, the researchers noted.
However, “these findings suggest that people should be aware of the risks from wildfire-generated PM2.5 during the summer and fall, including following best practices for people with asthma such as anticipating symptoms in warm months, carrying medications during summer activities, and expecting to stay indoors to avoid smoke exposure when wildfires have polluted the outdoor air,” Dr. Horne told this news organization.
In the current study, Dr. Horne and colleagues expected to see increases in the risk for asthma and COPD during summer wildfire season. “What was surprising was that the size of the risk of needing care of asthma appeared to occur just as rapidly after the PM2.5 became elevated during wildfire events as it did in the winter,” said Dr. Horne. “Further, the risk in the summer appeared to be greater than during the winter. Increases in hospitalization for asthma occurred on the same day and throughout the first week after a rise in air pollution in summer and early fall, and especially in children that risk remained increased for up to a month after the rise in air pollution,” he said.
Clinicians should be aware of environmental sources of respiratory declines caused by wildfire smoke that may prompt patients to seek care during wildfire events, said Horne. Finally, the general population should recognize the smell of smoke during warm months as an alert that leads to greater caution about spending time outdoors during wildfire events, he said. “Short-term PM2.5 elevations may affect respiratory health and have other effects such as on heart health,” Dr. Horne said. “In general, people should avoid outdoor exercise when air pollution is elevated, since the amount of air that is breathed in during exercise is substantially increased,” he added.
“Further research is needed regarding the mechanisms of effect from PM2.5 on health risk, including effects on respiratory and cardiovascular health,” said Dr. Horne. “This includes evaluating what biomarkers in the blood are changed by air pollution such as inflammatory factors, determining whether some medications may block or reduce the adverse effects of air pollution, and examining whether masks or indoor air purifiers have a meaningful benefit in protecting health during short-term air pollution elevations,” he said.
Data Reveal Respiratory Impact of Wildfires
“Fine particle air pollution has been linked to poor respiratory health outcomes, but relatively little is known about the specific impact of wildfire particulate pollution on patients living in urban population centers,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, said in an interview.
“Although it is known that wildfire risk is increasing throughout the western United States, the increase in the number of days per month with elevated fine particulate matter from 1999 to 2022 was striking,” said Dr. Rabin, who was not involved in the current study. “Over the same period, there was a decrease in the number of high fine particulate matter air pollution days related to the wintertime temperature inversion phenomenon when air pollutants are trapped in Utah’s valleys,” he said. “These data underscore the increased risk of wildfire-related air pollution relative to ‘traditional sources of air pollution from industrial and transportation sources,” he added.
Although the adverse effects of exposure to wildfire smoke and inversion season pollution on asthma were not unexpected, the degree of the effect size of wildfire smoke relative to inversion season was surprising, said Dr. Rabin.
“Why the wildfire smoke seems to have a worse impact on asthma outcomes could not be determined from this study, but there may be something inherently more dangerous about the cocktail of pollutants released when large wildfires burn uncontrolled,” he said. “I was surprised by the lack of association between wildfire smoke and adverse COPD outcomes; whether this relates to physiological differences or variations in healthcare-seeking behaviors between patients with asthma vs COPD is unknown,” he added.
The current study underscores the harmful effects of fine particulate pollution from wildfire smoke on health, and the increased risk for hospitalization for those with asthma even in urban environments far from the source of the fire, Dr. Rabin said.
However, limitations include the use of estimates of fine particulate pollution taken from monitoring stations that were an average of 14 km from the participants’ primary residences, and air quality measurements may not have accurately reflected exposure, Dr. Rabin noted. “Additionally, the population studied was not reflective of the US population, with approximately 80% of study participants described as non-Hispanic white,” he said. “Patients of color may have increased vulnerability to adverse outcomes from air pollution and therefore additional study is needed in these populations,” Dr. Rabin added.
The study was supported in part by the AIRHEALTH program project and by internal institutional funds. Dr. Horne disclosed serving on the advisory board of Opsis Health, previously consulting for Pfizer regarding risk scores and serving as site principal investigator of a grant funded by the Task Force for Global Health and a grant from the Patient-Centered Outcomes Research Institute and the NIH-funded RECOVER initiative. Dr. Rabin had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Short-term increases in fine particulate matter (PM2.5) resulting from wildfire smoke are becoming a greater global problem and have been associated with poor asthma and COPD outcomes, wrote Benjamin D. Horne, PhD, of the Intermountain Medical Center Heart Institute, Salt Lake City, Utah, and colleagues. However, the effect of short-term increases in PM2.5 on hospitalizations for asthma and COPD has not been well studied, they noted.
“Our primary reason for studying the association of air pollution in the summer/fall wildfire season separately from the winter is that the drought conditions in the western United States from 2012-2022 resulted in more wildfires and increasingly large wildfires across the west,” Dr. Horne said in an interview. “In part, this provided a chance to measure an increase of fine particulate matter (PM2.5) air pollution from wildfires and also to track what happened to their health when people were exposed to the PM2.5 from wildfire,” he said.
During 2020-2022, the PM2.5 produced during the wildfire season exceeded the PM2.5 levels measured in the winter for the first time, Dr. Horne said. In the part of Utah where the study was conducted, PM2.5 increases in winter because of a combination of concentrated PM2.5 from cars and industry and a weather phenomenon known as a temperature inversion, he said.
A temperature inversion occurs when mountain topography traps pollutants near the ground where the people are, but only during times of cold and snowy weather, Dr. Horne said.
“Past studies in the region were conducted with the assumption that the winter inversion was the primary source of pollution-related health risks, and public and healthcare guidance for health was based on avoiding winter air pollution,” Dr. Horne noted. However, “it may be that the smoke from wildfires requires people to also anticipate how to avoid exposure to PM2.5 during the summer,” he said.
In a study published in CHEST Pulmonary, the researchers reviewed data from 63,976 patients hospitalized with asthma and 18,514 hospitalized with COPD between January 1999 and March 2022 who lived in an area of Utah in which PM2.5 and ozone are measured by the Environmental Protection Agency. The average age of the asthma patients was 22.6 years; 51.0% were women, 16.0% had hypertension, and 10.1% had a history of smoking. The average age of the COPD patients was 63.5 years, 50.3% were women, 69.1% had hypertension, and 42.3% had a history of smoking.
In a regression analysis, the risk for asthma was significantly associated with days of increased PM2.5 during wildfire season and similar to the winter inversion (when cold air traps air pollutants), with odds ratios (ORs) of 1.057 and 1.023 for every 10 µg per m3 of particulate matter, respectively.
Although the risk for asthma hospitalization decreased after a week, a rebound occurred during wildfire season after a 4-week lag, with an OR of 1.098 for every 10 µg per m3 of particulate matter, the researchers wrote. A review of all months showed a significant association between a concurrent day increase in PM2.5 and asthma hospitalization (OR, 1.020 per every 10 µg per m3 of particulate matter, P = .0006).
By contrast, PM2.5 increases had only a weak association with hospitalizations for COPD during either wildfire season or winter inversion season, and ozone was not associated with increased risks for patients with asthma or COPD.
The findings were limited by several factors including the observational design, potential for confounding, and relatively homogeneous study population, the researchers noted.
However, “these findings suggest that people should be aware of the risks from wildfire-generated PM2.5 during the summer and fall, including following best practices for people with asthma such as anticipating symptoms in warm months, carrying medications during summer activities, and expecting to stay indoors to avoid smoke exposure when wildfires have polluted the outdoor air,” Dr. Horne told this news organization.
In the current study, Dr. Horne and colleagues expected to see increases in the risk for asthma and COPD during summer wildfire season. “What was surprising was that the size of the risk of needing care of asthma appeared to occur just as rapidly after the PM2.5 became elevated during wildfire events as it did in the winter,” said Dr. Horne. “Further, the risk in the summer appeared to be greater than during the winter. Increases in hospitalization for asthma occurred on the same day and throughout the first week after a rise in air pollution in summer and early fall, and especially in children that risk remained increased for up to a month after the rise in air pollution,” he said.
Clinicians should be aware of environmental sources of respiratory declines caused by wildfire smoke that may prompt patients to seek care during wildfire events, said Horne. Finally, the general population should recognize the smell of smoke during warm months as an alert that leads to greater caution about spending time outdoors during wildfire events, he said. “Short-term PM2.5 elevations may affect respiratory health and have other effects such as on heart health,” Dr. Horne said. “In general, people should avoid outdoor exercise when air pollution is elevated, since the amount of air that is breathed in during exercise is substantially increased,” he added.
“Further research is needed regarding the mechanisms of effect from PM2.5 on health risk, including effects on respiratory and cardiovascular health,” said Dr. Horne. “This includes evaluating what biomarkers in the blood are changed by air pollution such as inflammatory factors, determining whether some medications may block or reduce the adverse effects of air pollution, and examining whether masks or indoor air purifiers have a meaningful benefit in protecting health during short-term air pollution elevations,” he said.
Data Reveal Respiratory Impact of Wildfires
“Fine particle air pollution has been linked to poor respiratory health outcomes, but relatively little is known about the specific impact of wildfire particulate pollution on patients living in urban population centers,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, said in an interview.
“Although it is known that wildfire risk is increasing throughout the western United States, the increase in the number of days per month with elevated fine particulate matter from 1999 to 2022 was striking,” said Dr. Rabin, who was not involved in the current study. “Over the same period, there was a decrease in the number of high fine particulate matter air pollution days related to the wintertime temperature inversion phenomenon when air pollutants are trapped in Utah’s valleys,” he said. “These data underscore the increased risk of wildfire-related air pollution relative to ‘traditional sources of air pollution from industrial and transportation sources,” he added.
Although the adverse effects of exposure to wildfire smoke and inversion season pollution on asthma were not unexpected, the degree of the effect size of wildfire smoke relative to inversion season was surprising, said Dr. Rabin.
“Why the wildfire smoke seems to have a worse impact on asthma outcomes could not be determined from this study, but there may be something inherently more dangerous about the cocktail of pollutants released when large wildfires burn uncontrolled,” he said. “I was surprised by the lack of association between wildfire smoke and adverse COPD outcomes; whether this relates to physiological differences or variations in healthcare-seeking behaviors between patients with asthma vs COPD is unknown,” he added.
The current study underscores the harmful effects of fine particulate pollution from wildfire smoke on health, and the increased risk for hospitalization for those with asthma even in urban environments far from the source of the fire, Dr. Rabin said.
However, limitations include the use of estimates of fine particulate pollution taken from monitoring stations that were an average of 14 km from the participants’ primary residences, and air quality measurements may not have accurately reflected exposure, Dr. Rabin noted. “Additionally, the population studied was not reflective of the US population, with approximately 80% of study participants described as non-Hispanic white,” he said. “Patients of color may have increased vulnerability to adverse outcomes from air pollution and therefore additional study is needed in these populations,” Dr. Rabin added.
The study was supported in part by the AIRHEALTH program project and by internal institutional funds. Dr. Horne disclosed serving on the advisory board of Opsis Health, previously consulting for Pfizer regarding risk scores and serving as site principal investigator of a grant funded by the Task Force for Global Health and a grant from the Patient-Centered Outcomes Research Institute and the NIH-funded RECOVER initiative. Dr. Rabin had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Short-term increases in fine particulate matter (PM2.5) resulting from wildfire smoke are becoming a greater global problem and have been associated with poor asthma and COPD outcomes, wrote Benjamin D. Horne, PhD, of the Intermountain Medical Center Heart Institute, Salt Lake City, Utah, and colleagues. However, the effect of short-term increases in PM2.5 on hospitalizations for asthma and COPD has not been well studied, they noted.
“Our primary reason for studying the association of air pollution in the summer/fall wildfire season separately from the winter is that the drought conditions in the western United States from 2012-2022 resulted in more wildfires and increasingly large wildfires across the west,” Dr. Horne said in an interview. “In part, this provided a chance to measure an increase of fine particulate matter (PM2.5) air pollution from wildfires and also to track what happened to their health when people were exposed to the PM2.5 from wildfire,” he said.
During 2020-2022, the PM2.5 produced during the wildfire season exceeded the PM2.5 levels measured in the winter for the first time, Dr. Horne said. In the part of Utah where the study was conducted, PM2.5 increases in winter because of a combination of concentrated PM2.5 from cars and industry and a weather phenomenon known as a temperature inversion, he said.
A temperature inversion occurs when mountain topography traps pollutants near the ground where the people are, but only during times of cold and snowy weather, Dr. Horne said.
“Past studies in the region were conducted with the assumption that the winter inversion was the primary source of pollution-related health risks, and public and healthcare guidance for health was based on avoiding winter air pollution,” Dr. Horne noted. However, “it may be that the smoke from wildfires requires people to also anticipate how to avoid exposure to PM2.5 during the summer,” he said.
In a study published in CHEST Pulmonary, the researchers reviewed data from 63,976 patients hospitalized with asthma and 18,514 hospitalized with COPD between January 1999 and March 2022 who lived in an area of Utah in which PM2.5 and ozone are measured by the Environmental Protection Agency. The average age of the asthma patients was 22.6 years; 51.0% were women, 16.0% had hypertension, and 10.1% had a history of smoking. The average age of the COPD patients was 63.5 years, 50.3% were women, 69.1% had hypertension, and 42.3% had a history of smoking.
In a regression analysis, the risk for asthma was significantly associated with days of increased PM2.5 during wildfire season and similar to the winter inversion (when cold air traps air pollutants), with odds ratios (ORs) of 1.057 and 1.023 for every 10 µg per m3 of particulate matter, respectively.
Although the risk for asthma hospitalization decreased after a week, a rebound occurred during wildfire season after a 4-week lag, with an OR of 1.098 for every 10 µg per m3 of particulate matter, the researchers wrote. A review of all months showed a significant association between a concurrent day increase in PM2.5 and asthma hospitalization (OR, 1.020 per every 10 µg per m3 of particulate matter, P = .0006).
By contrast, PM2.5 increases had only a weak association with hospitalizations for COPD during either wildfire season or winter inversion season, and ozone was not associated with increased risks for patients with asthma or COPD.
The findings were limited by several factors including the observational design, potential for confounding, and relatively homogeneous study population, the researchers noted.
However, “these findings suggest that people should be aware of the risks from wildfire-generated PM2.5 during the summer and fall, including following best practices for people with asthma such as anticipating symptoms in warm months, carrying medications during summer activities, and expecting to stay indoors to avoid smoke exposure when wildfires have polluted the outdoor air,” Dr. Horne told this news organization.
In the current study, Dr. Horne and colleagues expected to see increases in the risk for asthma and COPD during summer wildfire season. “What was surprising was that the size of the risk of needing care of asthma appeared to occur just as rapidly after the PM2.5 became elevated during wildfire events as it did in the winter,” said Dr. Horne. “Further, the risk in the summer appeared to be greater than during the winter. Increases in hospitalization for asthma occurred on the same day and throughout the first week after a rise in air pollution in summer and early fall, and especially in children that risk remained increased for up to a month after the rise in air pollution,” he said.
Clinicians should be aware of environmental sources of respiratory declines caused by wildfire smoke that may prompt patients to seek care during wildfire events, said Horne. Finally, the general population should recognize the smell of smoke during warm months as an alert that leads to greater caution about spending time outdoors during wildfire events, he said. “Short-term PM2.5 elevations may affect respiratory health and have other effects such as on heart health,” Dr. Horne said. “In general, people should avoid outdoor exercise when air pollution is elevated, since the amount of air that is breathed in during exercise is substantially increased,” he added.
“Further research is needed regarding the mechanisms of effect from PM2.5 on health risk, including effects on respiratory and cardiovascular health,” said Dr. Horne. “This includes evaluating what biomarkers in the blood are changed by air pollution such as inflammatory factors, determining whether some medications may block or reduce the adverse effects of air pollution, and examining whether masks or indoor air purifiers have a meaningful benefit in protecting health during short-term air pollution elevations,” he said.
Data Reveal Respiratory Impact of Wildfires
“Fine particle air pollution has been linked to poor respiratory health outcomes, but relatively little is known about the specific impact of wildfire particulate pollution on patients living in urban population centers,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, said in an interview.
“Although it is known that wildfire risk is increasing throughout the western United States, the increase in the number of days per month with elevated fine particulate matter from 1999 to 2022 was striking,” said Dr. Rabin, who was not involved in the current study. “Over the same period, there was a decrease in the number of high fine particulate matter air pollution days related to the wintertime temperature inversion phenomenon when air pollutants are trapped in Utah’s valleys,” he said. “These data underscore the increased risk of wildfire-related air pollution relative to ‘traditional sources of air pollution from industrial and transportation sources,” he added.
Although the adverse effects of exposure to wildfire smoke and inversion season pollution on asthma were not unexpected, the degree of the effect size of wildfire smoke relative to inversion season was surprising, said Dr. Rabin.
“Why the wildfire smoke seems to have a worse impact on asthma outcomes could not be determined from this study, but there may be something inherently more dangerous about the cocktail of pollutants released when large wildfires burn uncontrolled,” he said. “I was surprised by the lack of association between wildfire smoke and adverse COPD outcomes; whether this relates to physiological differences or variations in healthcare-seeking behaviors between patients with asthma vs COPD is unknown,” he added.
The current study underscores the harmful effects of fine particulate pollution from wildfire smoke on health, and the increased risk for hospitalization for those with asthma even in urban environments far from the source of the fire, Dr. Rabin said.
However, limitations include the use of estimates of fine particulate pollution taken from monitoring stations that were an average of 14 km from the participants’ primary residences, and air quality measurements may not have accurately reflected exposure, Dr. Rabin noted. “Additionally, the population studied was not reflective of the US population, with approximately 80% of study participants described as non-Hispanic white,” he said. “Patients of color may have increased vulnerability to adverse outcomes from air pollution and therefore additional study is needed in these populations,” Dr. Rabin added.
The study was supported in part by the AIRHEALTH program project and by internal institutional funds. Dr. Horne disclosed serving on the advisory board of Opsis Health, previously consulting for Pfizer regarding risk scores and serving as site principal investigator of a grant funded by the Task Force for Global Health and a grant from the Patient-Centered Outcomes Research Institute and the NIH-funded RECOVER initiative. Dr. Rabin had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
No Surprises Act: Private Equity Scores Big in Arbitrations
Four organizations owned by private equity firms — including two provider groups — dominated the No Surprises Act’s disputed bill arbitration process in its first year, filing about 70% of 657,040 cases against insurers in 2023, a new report finds.
The findings, recently published in Health Affairs, suggest that private equity–owned organizations are forcefully challenging insurers about payments for certain kinds of out-of-network care.
Their fighting stance has paid off: The percentage of resolved arbitration cases won by providers jumped from 72% in the first quarter of 2023 to 85% in the last quarter, and they were awarded a median of more than 300% the contracted in-network rates for the services in question.
With many more out-of-network bills disputed by providers than expected, “the system is not working exactly the way it was anticipated when this law was written,” lead author Jack Hoadley, PhD, a research professor emeritus at Georgetown University’s McCourt School of Public Policy, Washington, DC, told this news organization.
And, he said, the public and the federal government may end up paying a price.
Congress passed the No Surprises Act in 2020 and then-President Donald Trump signed it. The landmark bill, which went into effect in 2022, was designed to protect patients from unexpected and often exorbitant “surprise” bills after they received some kinds of out-of-network care.
Now, many types of providers are forbidden from billing patients beyond normal in-network costs. In these cases, health plans and out-of-network providers — who don’t have mutual agreements — must wrangle over payment amounts, which are intended to not exceed inflation-adjusted 2019 median levels.
A binding arbitration process kicks in when a provider and a health plan fail to agree about how much the plan will pay for a service. Then, a third-party arbitrator is called in to make a ruling that’s binding. The process is controversial, and a flurry of lawsuits from providers have challenged it.
The new report, which updates an earlier analysis, examines data about disputed cases from all of 2023.
Of the 657,040 new cases filed in 2023, about 70% came from four private equity-funded organizations: Team Health, SCP Health, Radiology Partners, and Envision, which each provide physician services.
About half of the 2023 cases were from just four states: Texas, Florida, Tennessee, and Georgia. The report says the four organizations are especially active in those states. In contrast, Connecticut, Maryland, Massachusetts, and Washington state each had just 1500 or fewer cases filed last year.
Health plans challenged a third of cases as ineligible, and 22% of all resolved cases were deemed ineligible.
Providers won 80% of resolved challenges in 2023, although it’s not clear how much money they reaped. Still, it’s clear that “in the vast majority of the cases, insurers have to pay larger amounts to the provider,” Dr. Hoadley said.
Radiologists made a median of at least 500% of the in-network rate in their cases. Surgeons and neurologists made even more money — a median of at least 800% of the in-network rate. Overall, providers made 322%-350% of in-network rates, depending on the quarter.
Dr. Hoadley cautioned that only a small percentage of medical payments are disputed. In those cases, “the amount that the insurer offers is accepted, and that’s the end of the story.”
Why are the providers often reaping much more than typical payments for in-network services? It’s “really hard to know,” Dr. Hoadley said. But one factor, he said, may be the fact that providers are able to offer evidence challenging that amounts that insurers say they paid previously: “Hey, when we were in network, we were paid this much.”
It’s not clear whether the dispute-and-arbitration system will cost insurers — and patients — more in the long run. The Congressional Budget Office actually thought the No Surprises Act might lower the growth of premiums slightly and save the federal government money, Dr. Hoadley said, but that could potentially not happen. The flood of litigation also contributes to uncertainty, he said.
Alan Sager, PhD, professor of Health Law, Policy, and Management at Boston University School of Public Health, told this news organization that premiums are bound to rise as insurers react to higher costs. He also expects that providers will question the value of being in-network. “If you’re out-of-network and can obtain much higher payments, why would any doctor or hospital remain in-network, especially since they don’t lose out on patient volume?”
Why are provider groups owned by private equity firms so aggressive at challenging health plans? Loren Adler, a fellow and associate director of the Brookings Institution’s Center on Health Policy, told this news organization that these companies play large roles in fields affected by the No Surprises Act. These include emergency medicine, radiology, and anesthesiology, said Mr. Adler, who’s also studied the No Surprises Act’s dispute/arbitration system.
Mr. Adler added that larger companies “are better suited to deal with technical complexities of this process and spend the sort of upfront money to go through it.”
In the big picture, Mr. Adler said, the new study “raises question of whether Congress at some point wants to try to basically bring prices from the arbitration process back in line with average in-network prices.”
The study was funded by the Commonwealth Fund and Arnold Ventures. Dr. Hoadley, Dr. Sager, and Mr. Adler had no disclosures.
A version of this article first appeared on Medscape.com.
Four organizations owned by private equity firms — including two provider groups — dominated the No Surprises Act’s disputed bill arbitration process in its first year, filing about 70% of 657,040 cases against insurers in 2023, a new report finds.
The findings, recently published in Health Affairs, suggest that private equity–owned organizations are forcefully challenging insurers about payments for certain kinds of out-of-network care.
Their fighting stance has paid off: The percentage of resolved arbitration cases won by providers jumped from 72% in the first quarter of 2023 to 85% in the last quarter, and they were awarded a median of more than 300% the contracted in-network rates for the services in question.
With many more out-of-network bills disputed by providers than expected, “the system is not working exactly the way it was anticipated when this law was written,” lead author Jack Hoadley, PhD, a research professor emeritus at Georgetown University’s McCourt School of Public Policy, Washington, DC, told this news organization.
And, he said, the public and the federal government may end up paying a price.
Congress passed the No Surprises Act in 2020 and then-President Donald Trump signed it. The landmark bill, which went into effect in 2022, was designed to protect patients from unexpected and often exorbitant “surprise” bills after they received some kinds of out-of-network care.
Now, many types of providers are forbidden from billing patients beyond normal in-network costs. In these cases, health plans and out-of-network providers — who don’t have mutual agreements — must wrangle over payment amounts, which are intended to not exceed inflation-adjusted 2019 median levels.
A binding arbitration process kicks in when a provider and a health plan fail to agree about how much the plan will pay for a service. Then, a third-party arbitrator is called in to make a ruling that’s binding. The process is controversial, and a flurry of lawsuits from providers have challenged it.
The new report, which updates an earlier analysis, examines data about disputed cases from all of 2023.
Of the 657,040 new cases filed in 2023, about 70% came from four private equity-funded organizations: Team Health, SCP Health, Radiology Partners, and Envision, which each provide physician services.
About half of the 2023 cases were from just four states: Texas, Florida, Tennessee, and Georgia. The report says the four organizations are especially active in those states. In contrast, Connecticut, Maryland, Massachusetts, and Washington state each had just 1500 or fewer cases filed last year.
Health plans challenged a third of cases as ineligible, and 22% of all resolved cases were deemed ineligible.
Providers won 80% of resolved challenges in 2023, although it’s not clear how much money they reaped. Still, it’s clear that “in the vast majority of the cases, insurers have to pay larger amounts to the provider,” Dr. Hoadley said.
Radiologists made a median of at least 500% of the in-network rate in their cases. Surgeons and neurologists made even more money — a median of at least 800% of the in-network rate. Overall, providers made 322%-350% of in-network rates, depending on the quarter.
Dr. Hoadley cautioned that only a small percentage of medical payments are disputed. In those cases, “the amount that the insurer offers is accepted, and that’s the end of the story.”
Why are the providers often reaping much more than typical payments for in-network services? It’s “really hard to know,” Dr. Hoadley said. But one factor, he said, may be the fact that providers are able to offer evidence challenging that amounts that insurers say they paid previously: “Hey, when we were in network, we were paid this much.”
It’s not clear whether the dispute-and-arbitration system will cost insurers — and patients — more in the long run. The Congressional Budget Office actually thought the No Surprises Act might lower the growth of premiums slightly and save the federal government money, Dr. Hoadley said, but that could potentially not happen. The flood of litigation also contributes to uncertainty, he said.
Alan Sager, PhD, professor of Health Law, Policy, and Management at Boston University School of Public Health, told this news organization that premiums are bound to rise as insurers react to higher costs. He also expects that providers will question the value of being in-network. “If you’re out-of-network and can obtain much higher payments, why would any doctor or hospital remain in-network, especially since they don’t lose out on patient volume?”
Why are provider groups owned by private equity firms so aggressive at challenging health plans? Loren Adler, a fellow and associate director of the Brookings Institution’s Center on Health Policy, told this news organization that these companies play large roles in fields affected by the No Surprises Act. These include emergency medicine, radiology, and anesthesiology, said Mr. Adler, who’s also studied the No Surprises Act’s dispute/arbitration system.
Mr. Adler added that larger companies “are better suited to deal with technical complexities of this process and spend the sort of upfront money to go through it.”
In the big picture, Mr. Adler said, the new study “raises question of whether Congress at some point wants to try to basically bring prices from the arbitration process back in line with average in-network prices.”
The study was funded by the Commonwealth Fund and Arnold Ventures. Dr. Hoadley, Dr. Sager, and Mr. Adler had no disclosures.
A version of this article first appeared on Medscape.com.
Four organizations owned by private equity firms — including two provider groups — dominated the No Surprises Act’s disputed bill arbitration process in its first year, filing about 70% of 657,040 cases against insurers in 2023, a new report finds.
The findings, recently published in Health Affairs, suggest that private equity–owned organizations are forcefully challenging insurers about payments for certain kinds of out-of-network care.
Their fighting stance has paid off: The percentage of resolved arbitration cases won by providers jumped from 72% in the first quarter of 2023 to 85% in the last quarter, and they were awarded a median of more than 300% the contracted in-network rates for the services in question.
With many more out-of-network bills disputed by providers than expected, “the system is not working exactly the way it was anticipated when this law was written,” lead author Jack Hoadley, PhD, a research professor emeritus at Georgetown University’s McCourt School of Public Policy, Washington, DC, told this news organization.
And, he said, the public and the federal government may end up paying a price.
Congress passed the No Surprises Act in 2020 and then-President Donald Trump signed it. The landmark bill, which went into effect in 2022, was designed to protect patients from unexpected and often exorbitant “surprise” bills after they received some kinds of out-of-network care.
Now, many types of providers are forbidden from billing patients beyond normal in-network costs. In these cases, health plans and out-of-network providers — who don’t have mutual agreements — must wrangle over payment amounts, which are intended to not exceed inflation-adjusted 2019 median levels.
A binding arbitration process kicks in when a provider and a health plan fail to agree about how much the plan will pay for a service. Then, a third-party arbitrator is called in to make a ruling that’s binding. The process is controversial, and a flurry of lawsuits from providers have challenged it.
The new report, which updates an earlier analysis, examines data about disputed cases from all of 2023.
Of the 657,040 new cases filed in 2023, about 70% came from four private equity-funded organizations: Team Health, SCP Health, Radiology Partners, and Envision, which each provide physician services.
About half of the 2023 cases were from just four states: Texas, Florida, Tennessee, and Georgia. The report says the four organizations are especially active in those states. In contrast, Connecticut, Maryland, Massachusetts, and Washington state each had just 1500 or fewer cases filed last year.
Health plans challenged a third of cases as ineligible, and 22% of all resolved cases were deemed ineligible.
Providers won 80% of resolved challenges in 2023, although it’s not clear how much money they reaped. Still, it’s clear that “in the vast majority of the cases, insurers have to pay larger amounts to the provider,” Dr. Hoadley said.
Radiologists made a median of at least 500% of the in-network rate in their cases. Surgeons and neurologists made even more money — a median of at least 800% of the in-network rate. Overall, providers made 322%-350% of in-network rates, depending on the quarter.
Dr. Hoadley cautioned that only a small percentage of medical payments are disputed. In those cases, “the amount that the insurer offers is accepted, and that’s the end of the story.”
Why are the providers often reaping much more than typical payments for in-network services? It’s “really hard to know,” Dr. Hoadley said. But one factor, he said, may be the fact that providers are able to offer evidence challenging that amounts that insurers say they paid previously: “Hey, when we were in network, we were paid this much.”
It’s not clear whether the dispute-and-arbitration system will cost insurers — and patients — more in the long run. The Congressional Budget Office actually thought the No Surprises Act might lower the growth of premiums slightly and save the federal government money, Dr. Hoadley said, but that could potentially not happen. The flood of litigation also contributes to uncertainty, he said.
Alan Sager, PhD, professor of Health Law, Policy, and Management at Boston University School of Public Health, told this news organization that premiums are bound to rise as insurers react to higher costs. He also expects that providers will question the value of being in-network. “If you’re out-of-network and can obtain much higher payments, why would any doctor or hospital remain in-network, especially since they don’t lose out on patient volume?”
Why are provider groups owned by private equity firms so aggressive at challenging health plans? Loren Adler, a fellow and associate director of the Brookings Institution’s Center on Health Policy, told this news organization that these companies play large roles in fields affected by the No Surprises Act. These include emergency medicine, radiology, and anesthesiology, said Mr. Adler, who’s also studied the No Surprises Act’s dispute/arbitration system.
Mr. Adler added that larger companies “are better suited to deal with technical complexities of this process and spend the sort of upfront money to go through it.”
In the big picture, Mr. Adler said, the new study “raises question of whether Congress at some point wants to try to basically bring prices from the arbitration process back in line with average in-network prices.”
The study was funded by the Commonwealth Fund and Arnold Ventures. Dr. Hoadley, Dr. Sager, and Mr. Adler had no disclosures.
A version of this article first appeared on Medscape.com.
The New Formula for Stronger, Longer-Lasting Vaccines
Vaccines work pretty well. But with a little help, they could work better.
Stanford researchers have developed a new vaccine helper that combines two kinds of adjuvants, ingredients that improve a vaccine’s efficacy, in a novel, customizable system.
In lab tests, the experimental additive improved the effectiveness of COVID-19 and HIV vaccine candidates, though it could be adapted to stimulate immune responses to a variety of pathogens, the researchers said. It could also be used one day to fine-tune vaccines for vulnerable groups like young children, older adults, and those with compromised immune systems.
“Current vaccines are not perfect,” said lead study author Ben Ou, a PhD candidate and researcher in the lab of Eric Appel, PhD, an associate professor of materials science and engineering, at Stanford University in California. “Many fail to generate long-lasting immunity or immunity against closely related strains [such as] flu or COVID vaccines. One way to improve them is to design more potent vaccine adjuvants.”
The study marks an advance in an area of growing scientific interest: Combining different adjuvants to enhance the immune-stimulating effect.
The Stanford scientists developed sphere-shaped nanoparticles, like tiny round cages, made of saponins, immune-stimulating molecules common in adjuvant development. To these nanoparticles, they attached Toll-like receptor (TLR) agonists, molecules that have become a focus in vaccine research because they stimulate a variety of immune responses.
Dr. Ou and the team tested the new adjuvant platform in COVID and HIV vaccines, comparing it to vaccines containing alum, a widely used adjuvant. (Alum is not used in COVID vaccines available in the United States.)
The nanoparticle-adjuvanted vaccines triggered stronger, longer-lasting effects.
Notably, the combination of the new adjuvant system with a SARS-CoV-2 virus vaccine was effective in mice against the original SARS-CoV-2 virus and against Delta, Omicron, and other variants that emerged in the months and years after the initial outbreak.
“Since our nanoparticle adjuvant platform is more potent than traditional/clinical vaccine adjuvants,” Dr. Ou said, “we expected mice to produce broadly neutralizing antibodies and better breadth responses.”
100 Years of Adjuvants
The first vaccine adjuvants were aluminum salts mixed into shots against pertussis, diphtheria, and tetanus in the 1920s. Today, alum is still used in many vaccines, including shots for diphtheria, tetanus, and pertussis; hepatitis A and B; human papillomavirus; and pneumococcal disease.
But since the 1990s, new adjuvants have come on the scene. Saponin-based compounds, harvested from the soapbark tree, are used in the Novavax COVID-19 Vaccine, Adjuvanted; a synthetic DNA adjuvant in the Heplisav-B vaccine against hepatitis B; and oil in water adjuvants using squalene in the Fluad and Fluad Quadrivalent influenza vaccines. Other vaccines, including those for chickenpox, cholera, measles, mumps, rubella, and mRNA-based COVID vaccines from Pfizer-BioNTech and Moderna, don’t contain adjuvants.
TLR agonists have recently become research hotspots in vaccine science.
“TLR agonists activate the innate immune system, putting it on a heightened alert state that can result in a higher antibody production and longer-lasting protection,” said David Burkhart, PhD, a research professor in biomedical and pharmaceutical sciences at the University of Montana in Missoula. He is also the chief operating officer of Inimmune, a biotech company developing vaccines and immunotherapies.
Dr. Burkhart studies TLR agonists in vaccines and other applications. “Different combinations activate different parts of the immune system,” he said. “TLR4 might activate the army, while TLR7 might activate the air force. You might need both in one vaccine.”
TLR agonists have also shown promise against Alzheimer’s disease, allergies, cancer, and even addiction. In immune’s experimental immunotherapy using TLR agonists for advanced solid tumors has just entered human trials, and the company is looking at a TLR agonist therapy for allergic rhinitis.
Combining Forces
In the new study, researchers tested five different combinations of TLR agonists hooked to the saponin nanoparticle framework. Each elicited a slightly different response from the immune cells.
“Our immune systems generate different downstream immune responses based on which TLRs are activated,” Dr. Ou said.
Ultimately, the advance could spur the development of vaccines tuned for stronger immune protection.
“We need different immune responses to fight different types of pathogens,” Dr. Ou said. “Depending on what specific virus/disease the vaccine is formulated for, activation of one specific TLR may confer better protection than another TLR.”
According to Dr. Burkhart, combining a saponin with a TLR agonist has found success before.
Biopharma company GSK (formerly GlaxoSmithKline) used the combination in its AS01 adjuvant, in the vaccine Shingrix against herpes zoster. The live-attenuated yellow fever vaccine, given to more than 600 million people around the world and considered one of the most powerful vaccines ever developed, uses several TLR agonists.
The Stanford paper, Dr. Burkhart said, “is a nice demonstration of the enhanced efficacy [that] adjuvants can provide to vaccines by exploiting the synergy different adjuvants and TLR agonists can provide when used in combination.”
Tailoring Vaccines
The customizable aspect of TLR agonists is important too, Dr. Burkhart said.
“The human immune system changes dramatically from birth to childhood into adulthood into older maturity,” he said. “It’s not a one-size-fits-all. Vaccines need to be tailored to these populations for maximum effectiveness and safety. TLRAs [TLR agonists] are a highly valuable tool in the vaccine toolbox. I think it’s inevitable we’ll have more in the future.”
That’s what the Stanford researchers hope for.
They noted in the study that the nanoparticle platform could easily be used to test different TLR agonist adjuvant combinations in vaccines.
But human studies are still a ways off. Tests in larger animals would likely come next, Dr. Ou said.
“We now have a single nanoparticle adjuvant platform with formulations containing different TLRs,” Dr. Ou said. “Scientists can pick which specific formulation is the most suitable for their needs.”
A version of this article first appeared on Medscape.com.
Vaccines work pretty well. But with a little help, they could work better.
Stanford researchers have developed a new vaccine helper that combines two kinds of adjuvants, ingredients that improve a vaccine’s efficacy, in a novel, customizable system.
In lab tests, the experimental additive improved the effectiveness of COVID-19 and HIV vaccine candidates, though it could be adapted to stimulate immune responses to a variety of pathogens, the researchers said. It could also be used one day to fine-tune vaccines for vulnerable groups like young children, older adults, and those with compromised immune systems.
“Current vaccines are not perfect,” said lead study author Ben Ou, a PhD candidate and researcher in the lab of Eric Appel, PhD, an associate professor of materials science and engineering, at Stanford University in California. “Many fail to generate long-lasting immunity or immunity against closely related strains [such as] flu or COVID vaccines. One way to improve them is to design more potent vaccine adjuvants.”
The study marks an advance in an area of growing scientific interest: Combining different adjuvants to enhance the immune-stimulating effect.
The Stanford scientists developed sphere-shaped nanoparticles, like tiny round cages, made of saponins, immune-stimulating molecules common in adjuvant development. To these nanoparticles, they attached Toll-like receptor (TLR) agonists, molecules that have become a focus in vaccine research because they stimulate a variety of immune responses.
Dr. Ou and the team tested the new adjuvant platform in COVID and HIV vaccines, comparing it to vaccines containing alum, a widely used adjuvant. (Alum is not used in COVID vaccines available in the United States.)
The nanoparticle-adjuvanted vaccines triggered stronger, longer-lasting effects.
Notably, the combination of the new adjuvant system with a SARS-CoV-2 virus vaccine was effective in mice against the original SARS-CoV-2 virus and against Delta, Omicron, and other variants that emerged in the months and years after the initial outbreak.
“Since our nanoparticle adjuvant platform is more potent than traditional/clinical vaccine adjuvants,” Dr. Ou said, “we expected mice to produce broadly neutralizing antibodies and better breadth responses.”
100 Years of Adjuvants
The first vaccine adjuvants were aluminum salts mixed into shots against pertussis, diphtheria, and tetanus in the 1920s. Today, alum is still used in many vaccines, including shots for diphtheria, tetanus, and pertussis; hepatitis A and B; human papillomavirus; and pneumococcal disease.
But since the 1990s, new adjuvants have come on the scene. Saponin-based compounds, harvested from the soapbark tree, are used in the Novavax COVID-19 Vaccine, Adjuvanted; a synthetic DNA adjuvant in the Heplisav-B vaccine against hepatitis B; and oil in water adjuvants using squalene in the Fluad and Fluad Quadrivalent influenza vaccines. Other vaccines, including those for chickenpox, cholera, measles, mumps, rubella, and mRNA-based COVID vaccines from Pfizer-BioNTech and Moderna, don’t contain adjuvants.
TLR agonists have recently become research hotspots in vaccine science.
“TLR agonists activate the innate immune system, putting it on a heightened alert state that can result in a higher antibody production and longer-lasting protection,” said David Burkhart, PhD, a research professor in biomedical and pharmaceutical sciences at the University of Montana in Missoula. He is also the chief operating officer of Inimmune, a biotech company developing vaccines and immunotherapies.
Dr. Burkhart studies TLR agonists in vaccines and other applications. “Different combinations activate different parts of the immune system,” he said. “TLR4 might activate the army, while TLR7 might activate the air force. You might need both in one vaccine.”
TLR agonists have also shown promise against Alzheimer’s disease, allergies, cancer, and even addiction. In immune’s experimental immunotherapy using TLR agonists for advanced solid tumors has just entered human trials, and the company is looking at a TLR agonist therapy for allergic rhinitis.
Combining Forces
In the new study, researchers tested five different combinations of TLR agonists hooked to the saponin nanoparticle framework. Each elicited a slightly different response from the immune cells.
“Our immune systems generate different downstream immune responses based on which TLRs are activated,” Dr. Ou said.
Ultimately, the advance could spur the development of vaccines tuned for stronger immune protection.
“We need different immune responses to fight different types of pathogens,” Dr. Ou said. “Depending on what specific virus/disease the vaccine is formulated for, activation of one specific TLR may confer better protection than another TLR.”
According to Dr. Burkhart, combining a saponin with a TLR agonist has found success before.
Biopharma company GSK (formerly GlaxoSmithKline) used the combination in its AS01 adjuvant, in the vaccine Shingrix against herpes zoster. The live-attenuated yellow fever vaccine, given to more than 600 million people around the world and considered one of the most powerful vaccines ever developed, uses several TLR agonists.
The Stanford paper, Dr. Burkhart said, “is a nice demonstration of the enhanced efficacy [that] adjuvants can provide to vaccines by exploiting the synergy different adjuvants and TLR agonists can provide when used in combination.”
Tailoring Vaccines
The customizable aspect of TLR agonists is important too, Dr. Burkhart said.
“The human immune system changes dramatically from birth to childhood into adulthood into older maturity,” he said. “It’s not a one-size-fits-all. Vaccines need to be tailored to these populations for maximum effectiveness and safety. TLRAs [TLR agonists] are a highly valuable tool in the vaccine toolbox. I think it’s inevitable we’ll have more in the future.”
That’s what the Stanford researchers hope for.
They noted in the study that the nanoparticle platform could easily be used to test different TLR agonist adjuvant combinations in vaccines.
But human studies are still a ways off. Tests in larger animals would likely come next, Dr. Ou said.
“We now have a single nanoparticle adjuvant platform with formulations containing different TLRs,” Dr. Ou said. “Scientists can pick which specific formulation is the most suitable for their needs.”
A version of this article first appeared on Medscape.com.
Vaccines work pretty well. But with a little help, they could work better.
Stanford researchers have developed a new vaccine helper that combines two kinds of adjuvants, ingredients that improve a vaccine’s efficacy, in a novel, customizable system.
In lab tests, the experimental additive improved the effectiveness of COVID-19 and HIV vaccine candidates, though it could be adapted to stimulate immune responses to a variety of pathogens, the researchers said. It could also be used one day to fine-tune vaccines for vulnerable groups like young children, older adults, and those with compromised immune systems.
“Current vaccines are not perfect,” said lead study author Ben Ou, a PhD candidate and researcher in the lab of Eric Appel, PhD, an associate professor of materials science and engineering, at Stanford University in California. “Many fail to generate long-lasting immunity or immunity against closely related strains [such as] flu or COVID vaccines. One way to improve them is to design more potent vaccine adjuvants.”
The study marks an advance in an area of growing scientific interest: Combining different adjuvants to enhance the immune-stimulating effect.
The Stanford scientists developed sphere-shaped nanoparticles, like tiny round cages, made of saponins, immune-stimulating molecules common in adjuvant development. To these nanoparticles, they attached Toll-like receptor (TLR) agonists, molecules that have become a focus in vaccine research because they stimulate a variety of immune responses.
Dr. Ou and the team tested the new adjuvant platform in COVID and HIV vaccines, comparing it to vaccines containing alum, a widely used adjuvant. (Alum is not used in COVID vaccines available in the United States.)
The nanoparticle-adjuvanted vaccines triggered stronger, longer-lasting effects.
Notably, the combination of the new adjuvant system with a SARS-CoV-2 virus vaccine was effective in mice against the original SARS-CoV-2 virus and against Delta, Omicron, and other variants that emerged in the months and years after the initial outbreak.
“Since our nanoparticle adjuvant platform is more potent than traditional/clinical vaccine adjuvants,” Dr. Ou said, “we expected mice to produce broadly neutralizing antibodies and better breadth responses.”
100 Years of Adjuvants
The first vaccine adjuvants were aluminum salts mixed into shots against pertussis, diphtheria, and tetanus in the 1920s. Today, alum is still used in many vaccines, including shots for diphtheria, tetanus, and pertussis; hepatitis A and B; human papillomavirus; and pneumococcal disease.
But since the 1990s, new adjuvants have come on the scene. Saponin-based compounds, harvested from the soapbark tree, are used in the Novavax COVID-19 Vaccine, Adjuvanted; a synthetic DNA adjuvant in the Heplisav-B vaccine against hepatitis B; and oil in water adjuvants using squalene in the Fluad and Fluad Quadrivalent influenza vaccines. Other vaccines, including those for chickenpox, cholera, measles, mumps, rubella, and mRNA-based COVID vaccines from Pfizer-BioNTech and Moderna, don’t contain adjuvants.
TLR agonists have recently become research hotspots in vaccine science.
“TLR agonists activate the innate immune system, putting it on a heightened alert state that can result in a higher antibody production and longer-lasting protection,” said David Burkhart, PhD, a research professor in biomedical and pharmaceutical sciences at the University of Montana in Missoula. He is also the chief operating officer of Inimmune, a biotech company developing vaccines and immunotherapies.
Dr. Burkhart studies TLR agonists in vaccines and other applications. “Different combinations activate different parts of the immune system,” he said. “TLR4 might activate the army, while TLR7 might activate the air force. You might need both in one vaccine.”
TLR agonists have also shown promise against Alzheimer’s disease, allergies, cancer, and even addiction. In immune’s experimental immunotherapy using TLR agonists for advanced solid tumors has just entered human trials, and the company is looking at a TLR agonist therapy for allergic rhinitis.
Combining Forces
In the new study, researchers tested five different combinations of TLR agonists hooked to the saponin nanoparticle framework. Each elicited a slightly different response from the immune cells.
“Our immune systems generate different downstream immune responses based on which TLRs are activated,” Dr. Ou said.
Ultimately, the advance could spur the development of vaccines tuned for stronger immune protection.
“We need different immune responses to fight different types of pathogens,” Dr. Ou said. “Depending on what specific virus/disease the vaccine is formulated for, activation of one specific TLR may confer better protection than another TLR.”
According to Dr. Burkhart, combining a saponin with a TLR agonist has found success before.
Biopharma company GSK (formerly GlaxoSmithKline) used the combination in its AS01 adjuvant, in the vaccine Shingrix against herpes zoster. The live-attenuated yellow fever vaccine, given to more than 600 million people around the world and considered one of the most powerful vaccines ever developed, uses several TLR agonists.
The Stanford paper, Dr. Burkhart said, “is a nice demonstration of the enhanced efficacy [that] adjuvants can provide to vaccines by exploiting the synergy different adjuvants and TLR agonists can provide when used in combination.”
Tailoring Vaccines
The customizable aspect of TLR agonists is important too, Dr. Burkhart said.
“The human immune system changes dramatically from birth to childhood into adulthood into older maturity,” he said. “It’s not a one-size-fits-all. Vaccines need to be tailored to these populations for maximum effectiveness and safety. TLRAs [TLR agonists] are a highly valuable tool in the vaccine toolbox. I think it’s inevitable we’ll have more in the future.”
That’s what the Stanford researchers hope for.
They noted in the study that the nanoparticle platform could easily be used to test different TLR agonist adjuvant combinations in vaccines.
But human studies are still a ways off. Tests in larger animals would likely come next, Dr. Ou said.
“We now have a single nanoparticle adjuvant platform with formulations containing different TLRs,” Dr. Ou said. “Scientists can pick which specific formulation is the most suitable for their needs.”
A version of this article first appeared on Medscape.com.
FROM SCIENCE ADVANCES
Alcohol-Associated Liver Disease’s Changing Demographics
, accounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.
ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.
“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.
Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
As Women Consume More Alcohol, ALD Follows
Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.
Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.
Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.
Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.
Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”
Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.
Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
Certain Ethnic, Racial Minorities Have Higher Rates of ALD
In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.
A 2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.
Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.
ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.
The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.
As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.
Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.
Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.
“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
ALD Rates High in Young Adults, but the Tide May Be Changing
Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.
In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.
ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.
From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”
Younger adults may be more susceptible to ALD due to the way they drink.
In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.
Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).
“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”
Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.
“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
A version of this article first appeared on Medscape.com.
, accounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.
ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.
“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.
Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
As Women Consume More Alcohol, ALD Follows
Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.
Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.
Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.
Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.
Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”
Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.
Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
Certain Ethnic, Racial Minorities Have Higher Rates of ALD
In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.
A 2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.
Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.
ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.
The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.
As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.
Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.
Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.
“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
ALD Rates High in Young Adults, but the Tide May Be Changing
Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.
In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.
ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.
From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”
Younger adults may be more susceptible to ALD due to the way they drink.
In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.
Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).
“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”
Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.
“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
A version of this article first appeared on Medscape.com.
, accounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.
ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.
“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.
Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
As Women Consume More Alcohol, ALD Follows
Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.
Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.
Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.
Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.
Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”
Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.
Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
Certain Ethnic, Racial Minorities Have Higher Rates of ALD
In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.
A 2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.
Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.
ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.
The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.
As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.
Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.
Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.
“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
ALD Rates High in Young Adults, but the Tide May Be Changing
Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.
In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.
ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.
From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”
Younger adults may be more susceptible to ALD due to the way they drink.
In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.
Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).
“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”
Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.
“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
A version of this article first appeared on Medscape.com.
Signal of Suicide Ideation With GLP-1 RA Semaglutide, but Experts Urge Caution
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
First Non-Prescription Continuous Glucose Monitor Launches
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Evidence Growing for Inflammation’s Role in Elevating Risk for Psychiatric Illness
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.
Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders.
Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote.
In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said.
The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry.
Inflammatory Phenotype
Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk.
To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.
In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92).
“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported.
In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed.
The MR analysis suggested a possible causal relationship between leukocytes and depression.
The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.
“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote.
A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood.
This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
Support for Precision Psychiatry
This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization.
“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said.
“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added.
Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”
“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.
His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.
Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.
This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
A version of this article first appeared on Medscape.com.
Why Tradwives Are Trending
“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder
Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.
Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.
It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.
Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.
Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.
Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.
We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.
As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.
Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.
Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder
Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.
Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.
It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.
Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.
Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.
Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.
We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.
As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.
Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.
Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder
Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.
Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.
It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.
Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.
Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.
Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.
We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.
As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.
Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.
Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].