Feature

Type 2 diabetes patients hospitalized for worsening heart failure who took sotagliflozin remained alive and out of the hospital for more days after discharge than ones who took placebo, according to a new analysis.

The outcome measure –days alive and out of the hospital – may be a meaningful, patient-centered way of capturing disease burden, the researchers wrote in their paper, published in Annals of Internal Medicine.

“The question was: Can we keep patients alive and out of the hospital for any reason, accounting for the duration of each hospitalization?” author Michael Szarek, PhD, a visiting professor in the division of cardiology at the University of Colorado at Denver, Aurora, said in an interview.

“For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital 3% more days in relative terms or 2.9 days in absolute terms than those in the placebo group (91.8 vs. 88.9 days),” the researchers reported in their analysis of data from the SOLOIST-WHF trial.

“If you translate that to over the course of a year, that’s more than 10 days,” said Dr. Szarek, who is also a faculty member of CPC Clinical Research, an academic research organization affiliated with the University of Colorado.

Most patients in both groups survived to the end of the study without hospitalization, according to the paper.

Sotagliflozin, a sodium-glucose cotransporter 1 and SGLT2 inhibitor, is not approved in the United States. In 2019, the Food and Drug Administration rejected sotagliflozin as an adjunct to insulin for the treatment of type 1 diabetes after members of an advisory committee expressed concerns about an increased risk for diabetic ketoacidosis with the drug.
 

Methods and results

To examine whether sotagliflozin increased days alive and out of the hospital in the SOLOIST-WHF trial, Dr. Szarek and colleagues analyzed data from this randomized, double-blind, placebo-controlled study. The trial’s primary results were published in the New England Journal of Medicine in January 2021. Researchers conducted SOLOIST-WHF at more than 300 sites in 32 countries. The trial included 1,222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure.

In the new analysis the researchers looked at hospitalizations for any reason and the duration of hospital admissions after randomization. They analyzed days alive and out of the hospital using prespecified models.

Similar proportions of patients who received sotagliflozin and placebo were hospitalized at least once (38.5% vs. 41.4%) during a median follow-up of 9 months. Fewer patients who received sotagliflozin were hospitalized more than once (16.3% vs. 22.1%). In all, 64 patients in the sotagliflozin group and 76 patients in the placebo group died.

The reason for each hospitalization was unspecified, except for cases of heart failure, the authors noted. About 62% of hospitalizations during the trial were for reasons other than heart failure.
 

Outside expert cites similarities to initial trial

The results for days alive and out of the hospital are “not particularly surprising given the previous publication” of the trial’s primary results, but the new analysis provides a “different view of outcomes that might be clinically meaningful for patients,” commented Frank Brosius, MD, a professor of medicine at the University of Arizona, Tucson.

The SOLOIST-WHF trial indicated that doctors may be able to effectively treat patients with relatively new heart failure with sotagliflozin as long as patients are relatively stable, said Dr. Brosius, who coauthored an editorial in the New England Journal of Medicine that accompanied the initial results from the SOLOIST-WHF trial. It appears that previously reported benefits with regard to heart failure outcomes “showed up in these other indicators” in the secondary analysis.

Still, the effect sizes in the new analysis were relatively small and “probably more studies will be necessary” to examine these end points, he added.

SOLOIST-WHF was funded by Sanofi at initiation and by Lexicon Pharmaceuticals at completion. Dr. Szarek disclosed grants from Lexicon and grants and personal fees from Sanofi, as well as personal fees from other companies. His coauthors included employees of Lexicon and other researchers with financial ties to Lexicon and other pharmaceutical companies. Dr. Brosius disclosed personal fees from the American Diabetes Association and is a member of the Diabetic Kidney Disease Collaborative task force for the American Society of Nephrology that is broadly advocating the use of SGLT2 inhibitors by patients with diabetic kidney diseases. He also has participated in an advisory group for treatment of diabetic kidney disease for Gilead.

jremaly@mdedge.com

Type 2 diabetes patients hospitalized for worsening heart failure who took sotagliflozin remained alive and out of the hospital for more days after discharge than ones who took placebo, according to a new analysis.

The outcome measure –days alive and out of the hospital – may be a meaningful, patient-centered way of capturing disease burden, the researchers wrote in their paper, published in Annals of Internal Medicine.

“The question was: Can we keep patients alive and out of the hospital for any reason, accounting for the duration of each hospitalization?” author Michael Szarek, PhD, a visiting professor in the division of cardiology at the University of Colorado at Denver, Aurora, said in an interview.

“For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital 3% more days in relative terms or 2.9 days in absolute terms than those in the placebo group (91.8 vs. 88.9 days),” the researchers reported in their analysis of data from the SOLOIST-WHF trial.

“If you translate that to over the course of a year, that’s more than 10 days,” said Dr. Szarek, who is also a faculty member of CPC Clinical Research, an academic research organization affiliated with the University of Colorado.

Most patients in both groups survived to the end of the study without hospitalization, according to the paper.

Sotagliflozin, a sodium-glucose cotransporter 1 and SGLT2 inhibitor, is not approved in the United States. In 2019, the Food and Drug Administration rejected sotagliflozin as an adjunct to insulin for the treatment of type 1 diabetes after members of an advisory committee expressed concerns about an increased risk for diabetic ketoacidosis with the drug.
 

Methods and results

To examine whether sotagliflozin increased days alive and out of the hospital in the SOLOIST-WHF trial, Dr. Szarek and colleagues analyzed data from this randomized, double-blind, placebo-controlled study. The trial’s primary results were published in the New England Journal of Medicine in January 2021. Researchers conducted SOLOIST-WHF at more than 300 sites in 32 countries. The trial included 1,222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure.

In the new analysis the researchers looked at hospitalizations for any reason and the duration of hospital admissions after randomization. They analyzed days alive and out of the hospital using prespecified models.

Similar proportions of patients who received sotagliflozin and placebo were hospitalized at least once (38.5% vs. 41.4%) during a median follow-up of 9 months. Fewer patients who received sotagliflozin were hospitalized more than once (16.3% vs. 22.1%). In all, 64 patients in the sotagliflozin group and 76 patients in the placebo group died.

The reason for each hospitalization was unspecified, except for cases of heart failure, the authors noted. About 62% of hospitalizations during the trial were for reasons other than heart failure.
 

Outside expert cites similarities to initial trial

The results for days alive and out of the hospital are “not particularly surprising given the previous publication” of the trial’s primary results, but the new analysis provides a “different view of outcomes that might be clinically meaningful for patients,” commented Frank Brosius, MD, a professor of medicine at the University of Arizona, Tucson.

The SOLOIST-WHF trial indicated that doctors may be able to effectively treat patients with relatively new heart failure with sotagliflozin as long as patients are relatively stable, said Dr. Brosius, who coauthored an editorial in the New England Journal of Medicine that accompanied the initial results from the SOLOIST-WHF trial. It appears that previously reported benefits with regard to heart failure outcomes “showed up in these other indicators” in the secondary analysis.

Still, the effect sizes in the new analysis were relatively small and “probably more studies will be necessary” to examine these end points, he added.

SOLOIST-WHF was funded by Sanofi at initiation and by Lexicon Pharmaceuticals at completion. Dr. Szarek disclosed grants from Lexicon and grants and personal fees from Sanofi, as well as personal fees from other companies. His coauthors included employees of Lexicon and other researchers with financial ties to Lexicon and other pharmaceutical companies. Dr. Brosius disclosed personal fees from the American Diabetes Association and is a member of the Diabetic Kidney Disease Collaborative task force for the American Society of Nephrology that is broadly advocating the use of SGLT2 inhibitors by patients with diabetic kidney diseases. He also has participated in an advisory group for treatment of diabetic kidney disease for Gilead.

jremaly@mdedge.com

Type 2 diabetes patients hospitalized for worsening heart failure who took sotagliflozin remained alive and out of the hospital for more days after discharge than ones who took placebo, according to a new analysis.

The outcome measure –days alive and out of the hospital – may be a meaningful, patient-centered way of capturing disease burden, the researchers wrote in their paper, published in Annals of Internal Medicine.

“The question was: Can we keep patients alive and out of the hospital for any reason, accounting for the duration of each hospitalization?” author Michael Szarek, PhD, a visiting professor in the division of cardiology at the University of Colorado at Denver, Aurora, said in an interview.

“For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital 3% more days in relative terms or 2.9 days in absolute terms than those in the placebo group (91.8 vs. 88.9 days),” the researchers reported in their analysis of data from the SOLOIST-WHF trial.

“If you translate that to over the course of a year, that’s more than 10 days,” said Dr. Szarek, who is also a faculty member of CPC Clinical Research, an academic research organization affiliated with the University of Colorado.

Most patients in both groups survived to the end of the study without hospitalization, according to the paper.

Sotagliflozin, a sodium-glucose cotransporter 1 and SGLT2 inhibitor, is not approved in the United States. In 2019, the Food and Drug Administration rejected sotagliflozin as an adjunct to insulin for the treatment of type 1 diabetes after members of an advisory committee expressed concerns about an increased risk for diabetic ketoacidosis with the drug.
 

Methods and results

To examine whether sotagliflozin increased days alive and out of the hospital in the SOLOIST-WHF trial, Dr. Szarek and colleagues analyzed data from this randomized, double-blind, placebo-controlled study. The trial’s primary results were published in the New England Journal of Medicine in January 2021. Researchers conducted SOLOIST-WHF at more than 300 sites in 32 countries. The trial included 1,222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure.

In the new analysis the researchers looked at hospitalizations for any reason and the duration of hospital admissions after randomization. They analyzed days alive and out of the hospital using prespecified models.

Similar proportions of patients who received sotagliflozin and placebo were hospitalized at least once (38.5% vs. 41.4%) during a median follow-up of 9 months. Fewer patients who received sotagliflozin were hospitalized more than once (16.3% vs. 22.1%). In all, 64 patients in the sotagliflozin group and 76 patients in the placebo group died.

The reason for each hospitalization was unspecified, except for cases of heart failure, the authors noted. About 62% of hospitalizations during the trial were for reasons other than heart failure.
 

Outside expert cites similarities to initial trial

The results for days alive and out of the hospital are “not particularly surprising given the previous publication” of the trial’s primary results, but the new analysis provides a “different view of outcomes that might be clinically meaningful for patients,” commented Frank Brosius, MD, a professor of medicine at the University of Arizona, Tucson.

The SOLOIST-WHF trial indicated that doctors may be able to effectively treat patients with relatively new heart failure with sotagliflozin as long as patients are relatively stable, said Dr. Brosius, who coauthored an editorial in the New England Journal of Medicine that accompanied the initial results from the SOLOIST-WHF trial. It appears that previously reported benefits with regard to heart failure outcomes “showed up in these other indicators” in the secondary analysis.

Still, the effect sizes in the new analysis were relatively small and “probably more studies will be necessary” to examine these end points, he added.

SOLOIST-WHF was funded by Sanofi at initiation and by Lexicon Pharmaceuticals at completion. Dr. Szarek disclosed grants from Lexicon and grants and personal fees from Sanofi, as well as personal fees from other companies. His coauthors included employees of Lexicon and other researchers with financial ties to Lexicon and other pharmaceutical companies. Dr. Brosius disclosed personal fees from the American Diabetes Association and is a member of the Diabetic Kidney Disease Collaborative task force for the American Society of Nephrology that is broadly advocating the use of SGLT2 inhibitors by patients with diabetic kidney diseases. He also has participated in an advisory group for treatment of diabetic kidney disease for Gilead.

jremaly@mdedge.com

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

Patients hospitalized with COVID-19 experience cognitive and behavioral problems post discharge, new research shows.

Investigators found cognitive changes, depression, and PTSD in infected patients, both in the subacute phase and 10 months after hospital discharge.

“We showed that cognitive and behavioral alterations are associated with COVID-19 infection within 2 months from hospital discharge and that they partially persist in the post-COVID phase,” study investigator Elisa Canu, PhD, neuroimaging research unit, division of neuroscience, IRCCS San Raffaele Scientific Institute, Milan, told a press briefing.

The findings were presented at the annual congress of the European Academy of Neurology.
 

Executive dysfunction

Previous research suggests about 30% of COVID-19 survivors have cognitive disturbances and 30%-40% have psychopathological disorders including anxiety and depression, said Dr. Canu.

These disturbances have been associated with the severity of acute-phase respiratory symptoms, infection-triggered neuroinflammation, cerebrovascular alterations, and/or neurodegeneration.

However, it’s unclear whether these disturbances persist in the post-COVID phase.

To investigate, the researchers explored cognitive and psychopathological features in 49 patients with confirmed COVID-19 admitted to a hospital ED. They examined these factors at 2 months (subacute phase) and at 10 months (post-COVID phase).

Participants had an average age of 61 years (age range, 40-75 years) and 73% were men. Most had at least one cardiovascular risk factor such as hypertension (55%), smoking (22%), and dyslipidemia (18%).

At hospital admission, 71% had an abnormal neurologic exam, 59% had hypogeusia (reduced sense of taste), 45% hyposmia (reduced sense of smell), 39% headache, and 20% confusion or drowsiness. During hospitalization, 27% had noninvasive ventilation.

In addition to cognitive and neurologic assessments, participants underwent MRI 2 months after hospital discharge. Researchers obtained data on gray matter, white matter, and total brain volume.

At 2 months post discharge, 53% of patients presented with at least one cognitive deficit. Many deficits related to executive function including difficulty planning, attention, and problem solving (16%).

However, some participants had memory issues (6%) or visuospatial disturbances (6%). Almost a quarter (23%) presented with a combination of symptoms related to executive dysfunction.
 

Low oxygen tied to more cognitive deficits

More than one-third of patients experienced symptoms of depression (16%) or PTSD (18%).

Patients younger than 50 years had more executive dysfunction, with these symptoms affecting 75% of younger patients. “Our explanation for that is that younger people had a milder clinical profile regarding COVID, so they were cared for at home,” said Dr. Canu.

While in hospital, patients may be on “continued alert” and receive structured interventions for cognitive and behavioral issues, she said.

More severe respiratory symptoms at hospital admission were significantly associated with deficits during the subacute phase (P = .002 for information processing).

“Low levels of oxygen in the brain could lead to confusion, headache, and brain fog, and cause the cognitive disturbances that we see,” said Dr. Canu.

White-matter hyperintensities were linked to cognitive deficits during this phase (P < .001 for verbal memory and delayed recall).

“These white-matter lesions are probably preexisting due to cardiovascular risk factors that were present in our population and may have amplified the memory disturbances we saw,” commented Dr. Canu.

The investigators did not find a significant relationship between cognitive performance and brain volume. Dr. Canu noted that cognitive and psychopathological disturbances are linked. For instance, she said, a patient with PTSD or depression may also have problems with attention or memory.

In the post-COVID phase, cognitive symptoms were reduced from 53% to 36%; again, the most common deficit was combined executive dysfunction symptoms. Depression persisted in 15% of patients and PTSD in 18%.

“We still don’t know if these alterations are a consequence of the infection,” said Dr. Canu. “And we don’t know whether the deficits are reversible or are part of a neurodegenerative process.”

The researchers plan to follow these patients further. “We definitely need longer follow-up and bigger populations, if possible, to see if these cognitive and psychopathological disturbances can improve in some way,” said Dr. Canu.

The study results underline the need for neuropsychological and neurologic monitoring in COVID patients. Cognitive stimulation training and physical activity, preferably outdoors, could be beneficial, Dr. Canu added.

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

Antihypertensive medications that cross the blood-brain barrier (BBB) may be linked with less memory decline, compared with other drugs for high blood pressure, suggest the findings of a meta-analysis.

Over a 3-year period, cognitively normal older adults taking BBB-crossing antihypertensives demonstrated superior verbal memory, compared with similar individuals receiving non–BBB-crossing antihypertensives, reported lead author Jean K. Ho, PhD, of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, and colleagues.

According to the investigators, the findings add color to a known link between hypertension and neurologic degeneration, and may aid the search for new therapeutic targets.

“Hypertension is a well-established risk factor for cognitive decline and dementia, possibly through its effects on both cerebrovascular disease and Alzheimer’s disease,” Dr. Ho and colleagues wrote in Hypertension. “Studies of antihypertensive treatments have reported possible salutary effects on cognition and cerebrovascular disease, as well as Alzheimer’s disease neuropathology.”

In a previous study, individuals younger than 75 years exposed to antihypertensives had an 8% decreased risk of dementia per year of use, while another trial showed that intensive blood pressure–lowering therapy reduced mild cognitive impairment by 19%.

“Despite these encouraging findings ... larger meta-analytic studies have been hampered by the fact that pharmacokinetic properties are typically not considered in existing studies or routine clinical practice,” wrote Dr. Ho and colleagues. “The present study sought to fill this gap [in that it was] a large and longitudinal meta-analytic study of existing data recoded to assess the effects of BBB-crossing potential in renin-angiotensin system [RAS] treatments among hypertensive adults.”
 

Methods and results

The meta-analysis included randomized clinical trials, prospective cohort studies, and retrospective observational studies. The researchers assessed data on 12,849 individuals from 14 cohorts that received either BBB-crossing or non–BBB-crossing antihypertensives.

The BBB-crossing properties of RAS treatments were identified by a literature review. Of ACE inhibitors, captopril, fosinopril, lisinopril, perindopril, ramipril, and trandolapril were classified as BBB crossing, and benazepril, enalapril, moexipril, and quinapril were classified as non–BBB-crossing. Of ARBs, telmisartan and candesartan were considered BBB-crossing, and olmesartan, eprosartan, irbesartan, and losartan were tagged as non–BBB-crossing.

Cognition was assessed via the following seven domains: executive function, attention, verbal memory learning, language, mental status, recall, and processing speed.

Compared with individuals taking non–BBB-crossing antihypertensives, those taking BBB-crossing agents had significantly superior verbal memory (recall), with a maximum effect size of 0.07 (P = .03).

According to the investigators, this finding was particularly noteworthy, as the BBB-crossing group had relatively higher vascular risk burden and lower mean education level.

“These differences make it all the more remarkable that the BBB-crossing group displayed better memory ability over time despite these cognitive disadvantages,” the investigators wrote.

Still, not all the findings favored BBB-crossing agents. Individuals in the BBB-crossing group had relatively inferior attention ability, with a minimum effect size of –0.17 (P = .02).

The other cognitive measures were not significantly different between groups.
 

Clinicians may consider findings after accounting for other factors

Principal investigator Daniel A. Nation, PhD, associate professor of psychological science and a faculty member of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, suggested that the small difference in verbal memory between groups could be clinically significant over a longer period of time.

“Although the overall effect size was pretty small, if you look at how long it would take for someone [with dementia] to progress over many years of decline, it would actually end up being a pretty big effect,” Dr. Nation said in an interview. “Small effect sizes could actually end up preventing a lot of cases of dementia,” he added.

The conflicting results in the BBB-crossing group – better verbal memory but worse attention ability – were “surprising,” he noted.

“I sort of didn’t believe it at first,” Dr. Nation said, “because the memory finding is sort of replication – we’d observed the same exact effect on memory in a smaller sample in another study. ... The attention [finding], going another way, was a new thing.”

Dr. Nation suggested that the intergroup differences in attention ability may stem from idiosyncrasies of the tests used to measure that domain, which can be impacted by cardiovascular or brain vascular disease. Or it could be caused by something else entirely, he said, noting that further investigation is needed.

He added that the improvements in verbal memory within the BBB-crossing group could be caused by direct effects on the brain. He pointed out that certain ACE polymorphisms have been linked with Alzheimer’s disease risk, and those same polymorphisms, in animal models, lead to neurodegeneration, with reversal possible through administration of ACE inhibitors.

“It could be that what we’re observing has nothing really to do with blood pressure,” Dr. Nation explained. “This could be a neuronal effect on learning memory systems.”

He went on to suggest that clinicians may consider these findings when selecting antihypertensive agents for their patients, with the caveat that all other prescribing factors have already been taking to account.

“In the event that you’re going to give an ACE inhibitor or an angiotensin receptor blocker anyway, and it ends up being a somewhat arbitrary decision in terms of which specific drug you’re going to give, then perhaps this is a piece of information you would take into account – that one gets in the brain and one doesn’t – in somebody at risk for cognitive decline,” Dr. Nation said.
 

Exact mechanisms of action unknown

Hélène Girouard, PhD, assistant professor of pharmacology and physiology at the University of Montreal, said in an interview that the findings are “of considerable importance, knowing that brain alterations could begin as much as 30 years before manifestation of dementia.”

Since 2003, Dr. Girouard has been studying the cognitive effects of antihypertensive medications. She noted that previous studies involving rodents “have shown beneficial effects [of BBB-crossing antihypertensive drugs] on cognition independent of their effects on blood pressure.”

The drugs’ exact mechanisms of action, however, remain elusive, according to Dr. Girouard, who offered several possible explanations, including amelioration of BBB disruption, brain inflammation, cerebral blood flow dysregulation, cholinergic dysfunction, and neurologic deficits. “Whether these mechanisms may explain Ho and colleagues’ observations remains to be established,” she added.

Andrea L. Schneider, MD, PhD, assistant professor of neurology at the University of Pennsylvania, Philadelphia, applauded the study, but ultimately suggested that more research is needed to impact clinical decision-making.

“The results of this important and well-done study suggest that further investigation into targeted mechanism-based approaches to selecting hypertension treatment agents, with a specific focus on cognitive outcomes, is warranted,” Dr. Schneider said in an interview. “Before changing clinical practice, further work is necessary to disentangle contributions of medication mechanism, comorbid vascular risk factors, and achieved blood pressure reduction, among others.”

The investigators disclosed support from the National Institutes of Health, the Alzheimer’s Association, the Waksman Foundation of Japan, and others. The interviewees reported no relevant conflicts of interest.

Antihypertensive medications that cross the blood-brain barrier (BBB) may be linked with less memory decline, compared with other drugs for high blood pressure, suggest the findings of a meta-analysis.

Over a 3-year period, cognitively normal older adults taking BBB-crossing antihypertensives demonstrated superior verbal memory, compared with similar individuals receiving non–BBB-crossing antihypertensives, reported lead author Jean K. Ho, PhD, of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, and colleagues.

According to the investigators, the findings add color to a known link between hypertension and neurologic degeneration, and may aid the search for new therapeutic targets.

“Hypertension is a well-established risk factor for cognitive decline and dementia, possibly through its effects on both cerebrovascular disease and Alzheimer’s disease,” Dr. Ho and colleagues wrote in Hypertension. “Studies of antihypertensive treatments have reported possible salutary effects on cognition and cerebrovascular disease, as well as Alzheimer’s disease neuropathology.”

In a previous study, individuals younger than 75 years exposed to antihypertensives had an 8% decreased risk of dementia per year of use, while another trial showed that intensive blood pressure–lowering therapy reduced mild cognitive impairment by 19%.

“Despite these encouraging findings ... larger meta-analytic studies have been hampered by the fact that pharmacokinetic properties are typically not considered in existing studies or routine clinical practice,” wrote Dr. Ho and colleagues. “The present study sought to fill this gap [in that it was] a large and longitudinal meta-analytic study of existing data recoded to assess the effects of BBB-crossing potential in renin-angiotensin system [RAS] treatments among hypertensive adults.”
 

Methods and results

The meta-analysis included randomized clinical trials, prospective cohort studies, and retrospective observational studies. The researchers assessed data on 12,849 individuals from 14 cohorts that received either BBB-crossing or non–BBB-crossing antihypertensives.

The BBB-crossing properties of RAS treatments were identified by a literature review. Of ACE inhibitors, captopril, fosinopril, lisinopril, perindopril, ramipril, and trandolapril were classified as BBB crossing, and benazepril, enalapril, moexipril, and quinapril were classified as non–BBB-crossing. Of ARBs, telmisartan and candesartan were considered BBB-crossing, and olmesartan, eprosartan, irbesartan, and losartan were tagged as non–BBB-crossing.

Cognition was assessed via the following seven domains: executive function, attention, verbal memory learning, language, mental status, recall, and processing speed.

Compared with individuals taking non–BBB-crossing antihypertensives, those taking BBB-crossing agents had significantly superior verbal memory (recall), with a maximum effect size of 0.07 (P = .03).

According to the investigators, this finding was particularly noteworthy, as the BBB-crossing group had relatively higher vascular risk burden and lower mean education level.

“These differences make it all the more remarkable that the BBB-crossing group displayed better memory ability over time despite these cognitive disadvantages,” the investigators wrote.

Still, not all the findings favored BBB-crossing agents. Individuals in the BBB-crossing group had relatively inferior attention ability, with a minimum effect size of –0.17 (P = .02).

The other cognitive measures were not significantly different between groups.
 

Clinicians may consider findings after accounting for other factors

Principal investigator Daniel A. Nation, PhD, associate professor of psychological science and a faculty member of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, suggested that the small difference in verbal memory between groups could be clinically significant over a longer period of time.

“Although the overall effect size was pretty small, if you look at how long it would take for someone [with dementia] to progress over many years of decline, it would actually end up being a pretty big effect,” Dr. Nation said in an interview. “Small effect sizes could actually end up preventing a lot of cases of dementia,” he added.

The conflicting results in the BBB-crossing group – better verbal memory but worse attention ability – were “surprising,” he noted.

“I sort of didn’t believe it at first,” Dr. Nation said, “because the memory finding is sort of replication – we’d observed the same exact effect on memory in a smaller sample in another study. ... The attention [finding], going another way, was a new thing.”

Dr. Nation suggested that the intergroup differences in attention ability may stem from idiosyncrasies of the tests used to measure that domain, which can be impacted by cardiovascular or brain vascular disease. Or it could be caused by something else entirely, he said, noting that further investigation is needed.

He added that the improvements in verbal memory within the BBB-crossing group could be caused by direct effects on the brain. He pointed out that certain ACE polymorphisms have been linked with Alzheimer’s disease risk, and those same polymorphisms, in animal models, lead to neurodegeneration, with reversal possible through administration of ACE inhibitors.

“It could be that what we’re observing has nothing really to do with blood pressure,” Dr. Nation explained. “This could be a neuronal effect on learning memory systems.”

He went on to suggest that clinicians may consider these findings when selecting antihypertensive agents for their patients, with the caveat that all other prescribing factors have already been taking to account.

“In the event that you’re going to give an ACE inhibitor or an angiotensin receptor blocker anyway, and it ends up being a somewhat arbitrary decision in terms of which specific drug you’re going to give, then perhaps this is a piece of information you would take into account – that one gets in the brain and one doesn’t – in somebody at risk for cognitive decline,” Dr. Nation said.
 

Exact mechanisms of action unknown

Hélène Girouard, PhD, assistant professor of pharmacology and physiology at the University of Montreal, said in an interview that the findings are “of considerable importance, knowing that brain alterations could begin as much as 30 years before manifestation of dementia.”

Since 2003, Dr. Girouard has been studying the cognitive effects of antihypertensive medications. She noted that previous studies involving rodents “have shown beneficial effects [of BBB-crossing antihypertensive drugs] on cognition independent of their effects on blood pressure.”

The drugs’ exact mechanisms of action, however, remain elusive, according to Dr. Girouard, who offered several possible explanations, including amelioration of BBB disruption, brain inflammation, cerebral blood flow dysregulation, cholinergic dysfunction, and neurologic deficits. “Whether these mechanisms may explain Ho and colleagues’ observations remains to be established,” she added.

Andrea L. Schneider, MD, PhD, assistant professor of neurology at the University of Pennsylvania, Philadelphia, applauded the study, but ultimately suggested that more research is needed to impact clinical decision-making.

“The results of this important and well-done study suggest that further investigation into targeted mechanism-based approaches to selecting hypertension treatment agents, with a specific focus on cognitive outcomes, is warranted,” Dr. Schneider said in an interview. “Before changing clinical practice, further work is necessary to disentangle contributions of medication mechanism, comorbid vascular risk factors, and achieved blood pressure reduction, among others.”

The investigators disclosed support from the National Institutes of Health, the Alzheimer’s Association, the Waksman Foundation of Japan, and others. The interviewees reported no relevant conflicts of interest.

Antihypertensive medications that cross the blood-brain barrier (BBB) may be linked with less memory decline, compared with other drugs for high blood pressure, suggest the findings of a meta-analysis.

Over a 3-year period, cognitively normal older adults taking BBB-crossing antihypertensives demonstrated superior verbal memory, compared with similar individuals receiving non–BBB-crossing antihypertensives, reported lead author Jean K. Ho, PhD, of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, and colleagues.

According to the investigators, the findings add color to a known link between hypertension and neurologic degeneration, and may aid the search for new therapeutic targets.

“Hypertension is a well-established risk factor for cognitive decline and dementia, possibly through its effects on both cerebrovascular disease and Alzheimer’s disease,” Dr. Ho and colleagues wrote in Hypertension. “Studies of antihypertensive treatments have reported possible salutary effects on cognition and cerebrovascular disease, as well as Alzheimer’s disease neuropathology.”

In a previous study, individuals younger than 75 years exposed to antihypertensives had an 8% decreased risk of dementia per year of use, while another trial showed that intensive blood pressure–lowering therapy reduced mild cognitive impairment by 19%.

“Despite these encouraging findings ... larger meta-analytic studies have been hampered by the fact that pharmacokinetic properties are typically not considered in existing studies or routine clinical practice,” wrote Dr. Ho and colleagues. “The present study sought to fill this gap [in that it was] a large and longitudinal meta-analytic study of existing data recoded to assess the effects of BBB-crossing potential in renin-angiotensin system [RAS] treatments among hypertensive adults.”
 

Methods and results

The meta-analysis included randomized clinical trials, prospective cohort studies, and retrospective observational studies. The researchers assessed data on 12,849 individuals from 14 cohorts that received either BBB-crossing or non–BBB-crossing antihypertensives.

The BBB-crossing properties of RAS treatments were identified by a literature review. Of ACE inhibitors, captopril, fosinopril, lisinopril, perindopril, ramipril, and trandolapril were classified as BBB crossing, and benazepril, enalapril, moexipril, and quinapril were classified as non–BBB-crossing. Of ARBs, telmisartan and candesartan were considered BBB-crossing, and olmesartan, eprosartan, irbesartan, and losartan were tagged as non–BBB-crossing.

Cognition was assessed via the following seven domains: executive function, attention, verbal memory learning, language, mental status, recall, and processing speed.

Compared with individuals taking non–BBB-crossing antihypertensives, those taking BBB-crossing agents had significantly superior verbal memory (recall), with a maximum effect size of 0.07 (P = .03).

According to the investigators, this finding was particularly noteworthy, as the BBB-crossing group had relatively higher vascular risk burden and lower mean education level.

“These differences make it all the more remarkable that the BBB-crossing group displayed better memory ability over time despite these cognitive disadvantages,” the investigators wrote.

Still, not all the findings favored BBB-crossing agents. Individuals in the BBB-crossing group had relatively inferior attention ability, with a minimum effect size of –0.17 (P = .02).

The other cognitive measures were not significantly different between groups.
 

Clinicians may consider findings after accounting for other factors

Principal investigator Daniel A. Nation, PhD, associate professor of psychological science and a faculty member of the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, suggested that the small difference in verbal memory between groups could be clinically significant over a longer period of time.

“Although the overall effect size was pretty small, if you look at how long it would take for someone [with dementia] to progress over many years of decline, it would actually end up being a pretty big effect,” Dr. Nation said in an interview. “Small effect sizes could actually end up preventing a lot of cases of dementia,” he added.

The conflicting results in the BBB-crossing group – better verbal memory but worse attention ability – were “surprising,” he noted.

“I sort of didn’t believe it at first,” Dr. Nation said, “because the memory finding is sort of replication – we’d observed the same exact effect on memory in a smaller sample in another study. ... The attention [finding], going another way, was a new thing.”

Dr. Nation suggested that the intergroup differences in attention ability may stem from idiosyncrasies of the tests used to measure that domain, which can be impacted by cardiovascular or brain vascular disease. Or it could be caused by something else entirely, he said, noting that further investigation is needed.

He added that the improvements in verbal memory within the BBB-crossing group could be caused by direct effects on the brain. He pointed out that certain ACE polymorphisms have been linked with Alzheimer’s disease risk, and those same polymorphisms, in animal models, lead to neurodegeneration, with reversal possible through administration of ACE inhibitors.

“It could be that what we’re observing has nothing really to do with blood pressure,” Dr. Nation explained. “This could be a neuronal effect on learning memory systems.”

He went on to suggest that clinicians may consider these findings when selecting antihypertensive agents for their patients, with the caveat that all other prescribing factors have already been taking to account.

“In the event that you’re going to give an ACE inhibitor or an angiotensin receptor blocker anyway, and it ends up being a somewhat arbitrary decision in terms of which specific drug you’re going to give, then perhaps this is a piece of information you would take into account – that one gets in the brain and one doesn’t – in somebody at risk for cognitive decline,” Dr. Nation said.
 

Exact mechanisms of action unknown

Hélène Girouard, PhD, assistant professor of pharmacology and physiology at the University of Montreal, said in an interview that the findings are “of considerable importance, knowing that brain alterations could begin as much as 30 years before manifestation of dementia.”

Since 2003, Dr. Girouard has been studying the cognitive effects of antihypertensive medications. She noted that previous studies involving rodents “have shown beneficial effects [of BBB-crossing antihypertensive drugs] on cognition independent of their effects on blood pressure.”

The drugs’ exact mechanisms of action, however, remain elusive, according to Dr. Girouard, who offered several possible explanations, including amelioration of BBB disruption, brain inflammation, cerebral blood flow dysregulation, cholinergic dysfunction, and neurologic deficits. “Whether these mechanisms may explain Ho and colleagues’ observations remains to be established,” she added.

Andrea L. Schneider, MD, PhD, assistant professor of neurology at the University of Pennsylvania, Philadelphia, applauded the study, but ultimately suggested that more research is needed to impact clinical decision-making.

“The results of this important and well-done study suggest that further investigation into targeted mechanism-based approaches to selecting hypertension treatment agents, with a specific focus on cognitive outcomes, is warranted,” Dr. Schneider said in an interview. “Before changing clinical practice, further work is necessary to disentangle contributions of medication mechanism, comorbid vascular risk factors, and achieved blood pressure reduction, among others.”

The investigators disclosed support from the National Institutes of Health, the Alzheimer’s Association, the Waksman Foundation of Japan, and others. The interviewees reported no relevant conflicts of interest.

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

jremaly@mdedge.com

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

jremaly@mdedge.com

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

jremaly@mdedge.com

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

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

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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