MDedge Neurology

The stress of living through a pandemic may cause brain inflammation even in those uninfected with SARS-CoV-2, a study suggests.

Healthy individuals who tested negative for the virus that causes COVID-19 had elevated levels of inflammatory markers known to be involved in depression, stress, and mental fatigue. The study indicates a possible link between pandemic-associated stressors and neuroimmune responses.

“The most important finding is the evidence of neuroinflammation in noninfected, otherwise healthy participants, which may explain the variety of sickness-behavior-like symptoms experienced by many during the pandemic,” lead author Ludovica Brusaferri, PhD, a postdoctoral research fellow at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.

The study was published online Feb. 16 in Brain, Behavior, and Immunity.
 

Impact of pandemic stress?

Reports of psychological distress have increased considerably in the United States during the pandemic, including among those not infected with SARS-CoV-2.

To better understand the effects of the pandemic on brain and mental health, the investigators retrospectively analyzed data collected from 57 people who were enrolled as control subjects for unrelated studies before the pandemic began.

They also enrolled 15 people living in Massachusetts during that state’s 2-month lockdown/stay-at-home order from March to May 2020, all of whom had tested negative for COVID-19 antibodies.

The investigators used PET and MRI imaging and blood sample analyses to investigate whether there were any differences in the brains of healthy people before and during the pandemic following the lockdown.

Compared with the control group, the pandemic cohort had elevated levels of 18 kDa translocator protein (TSPO) and myoinositol, inflammatory markers in the brain. Increased TSPO has been associated with depression and suicidal thoughts and elevated myoinositol has been linked to schizophrenia.

Blood levels of two inflammatory markers, interleukin-16 and monocyte chemoattractant protein-1, were also elevated in the pandemic cohort, although to a lesser extent.

TSPO levels were especially high in participants in the pandemic cohort who reported moodiness and mental and physical fatigue, compared with those reporting few or no symptoms.

“These findings provide support to a role for neuroinflammation in stress, an observation that, if replicated, might help guide the development of novel treatments focused on the reduction of brain inflammation,” study author Marco Loggia, PhD, codirector of the Center for Integrative Pain NeuroImaging at Mass General and Harvard Medical School, told this news organization.

Although the data showing increased neuroinflammation were collected when participants were under a stay-at-home order, the researchers said it’s not clear that this was the cause.

“We’re not saying it is the lockdown that was causing it,” Dr. Loggia said. “It could have been social isolation, changes in diet, or changes in exercise patterns. We don’t know exactly what the cause was so, maybe.”
 

A significant contribution

Commenting on the study for this news organization, Ning Quan, PhD, professor of biomedical science at Florida Atlantic University, Boca Raton, said although questions remain, the findings offer valuable information.

“This study contributes significantly to our understanding of how pandemic stress might impact our brain and behavior,” Dr. Quan said. “The main advance that this paper provides is that fatigue or brain fog could be induced in individuals with COVID infection during the pandemic.”

However, Dr. Quan added, the study has a number of limitations, including a small sample size, which makes it difficult to generalize the results.

“Another issue is the subjects of the study all lived in Massachusetts,” Dr. Quan added. “Subjects from different states or different countries could yield different results.”

The study was funded by the National Institutes of Health and by the Landreth Family Foundation. The study authors and Dr. Quan have disclosed no relevant financial relationships.

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

The stress of living through a pandemic may cause brain inflammation even in those uninfected with SARS-CoV-2, a study suggests.

Healthy individuals who tested negative for the virus that causes COVID-19 had elevated levels of inflammatory markers known to be involved in depression, stress, and mental fatigue. The study indicates a possible link between pandemic-associated stressors and neuroimmune responses.

“The most important finding is the evidence of neuroinflammation in noninfected, otherwise healthy participants, which may explain the variety of sickness-behavior-like symptoms experienced by many during the pandemic,” lead author Ludovica Brusaferri, PhD, a postdoctoral research fellow at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.

The study was published online Feb. 16 in Brain, Behavior, and Immunity.
 

Impact of pandemic stress?

Reports of psychological distress have increased considerably in the United States during the pandemic, including among those not infected with SARS-CoV-2.

To better understand the effects of the pandemic on brain and mental health, the investigators retrospectively analyzed data collected from 57 people who were enrolled as control subjects for unrelated studies before the pandemic began.

They also enrolled 15 people living in Massachusetts during that state’s 2-month lockdown/stay-at-home order from March to May 2020, all of whom had tested negative for COVID-19 antibodies.

The investigators used PET and MRI imaging and blood sample analyses to investigate whether there were any differences in the brains of healthy people before and during the pandemic following the lockdown.

Compared with the control group, the pandemic cohort had elevated levels of 18 kDa translocator protein (TSPO) and myoinositol, inflammatory markers in the brain. Increased TSPO has been associated with depression and suicidal thoughts and elevated myoinositol has been linked to schizophrenia.

Blood levels of two inflammatory markers, interleukin-16 and monocyte chemoattractant protein-1, were also elevated in the pandemic cohort, although to a lesser extent.

TSPO levels were especially high in participants in the pandemic cohort who reported moodiness and mental and physical fatigue, compared with those reporting few or no symptoms.

“These findings provide support to a role for neuroinflammation in stress, an observation that, if replicated, might help guide the development of novel treatments focused on the reduction of brain inflammation,” study author Marco Loggia, PhD, codirector of the Center for Integrative Pain NeuroImaging at Mass General and Harvard Medical School, told this news organization.

Although the data showing increased neuroinflammation were collected when participants were under a stay-at-home order, the researchers said it’s not clear that this was the cause.

“We’re not saying it is the lockdown that was causing it,” Dr. Loggia said. “It could have been social isolation, changes in diet, or changes in exercise patterns. We don’t know exactly what the cause was so, maybe.”
 

A significant contribution

Commenting on the study for this news organization, Ning Quan, PhD, professor of biomedical science at Florida Atlantic University, Boca Raton, said although questions remain, the findings offer valuable information.

“This study contributes significantly to our understanding of how pandemic stress might impact our brain and behavior,” Dr. Quan said. “The main advance that this paper provides is that fatigue or brain fog could be induced in individuals with COVID infection during the pandemic.”

However, Dr. Quan added, the study has a number of limitations, including a small sample size, which makes it difficult to generalize the results.

“Another issue is the subjects of the study all lived in Massachusetts,” Dr. Quan added. “Subjects from different states or different countries could yield different results.”

The study was funded by the National Institutes of Health and by the Landreth Family Foundation. The study authors and Dr. Quan have disclosed no relevant financial relationships.

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

The stress of living through a pandemic may cause brain inflammation even in those uninfected with SARS-CoV-2, a study suggests.

Healthy individuals who tested negative for the virus that causes COVID-19 had elevated levels of inflammatory markers known to be involved in depression, stress, and mental fatigue. The study indicates a possible link between pandemic-associated stressors and neuroimmune responses.

“The most important finding is the evidence of neuroinflammation in noninfected, otherwise healthy participants, which may explain the variety of sickness-behavior-like symptoms experienced by many during the pandemic,” lead author Ludovica Brusaferri, PhD, a postdoctoral research fellow at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.

The study was published online Feb. 16 in Brain, Behavior, and Immunity.
 

Impact of pandemic stress?

Reports of psychological distress have increased considerably in the United States during the pandemic, including among those not infected with SARS-CoV-2.

To better understand the effects of the pandemic on brain and mental health, the investigators retrospectively analyzed data collected from 57 people who were enrolled as control subjects for unrelated studies before the pandemic began.

They also enrolled 15 people living in Massachusetts during that state’s 2-month lockdown/stay-at-home order from March to May 2020, all of whom had tested negative for COVID-19 antibodies.

The investigators used PET and MRI imaging and blood sample analyses to investigate whether there were any differences in the brains of healthy people before and during the pandemic following the lockdown.

Compared with the control group, the pandemic cohort had elevated levels of 18 kDa translocator protein (TSPO) and myoinositol, inflammatory markers in the brain. Increased TSPO has been associated with depression and suicidal thoughts and elevated myoinositol has been linked to schizophrenia.

Blood levels of two inflammatory markers, interleukin-16 and monocyte chemoattractant protein-1, were also elevated in the pandemic cohort, although to a lesser extent.

TSPO levels were especially high in participants in the pandemic cohort who reported moodiness and mental and physical fatigue, compared with those reporting few or no symptoms.

“These findings provide support to a role for neuroinflammation in stress, an observation that, if replicated, might help guide the development of novel treatments focused on the reduction of brain inflammation,” study author Marco Loggia, PhD, codirector of the Center for Integrative Pain NeuroImaging at Mass General and Harvard Medical School, told this news organization.

Although the data showing increased neuroinflammation were collected when participants were under a stay-at-home order, the researchers said it’s not clear that this was the cause.

“We’re not saying it is the lockdown that was causing it,” Dr. Loggia said. “It could have been social isolation, changes in diet, or changes in exercise patterns. We don’t know exactly what the cause was so, maybe.”
 

A significant contribution

Commenting on the study for this news organization, Ning Quan, PhD, professor of biomedical science at Florida Atlantic University, Boca Raton, said although questions remain, the findings offer valuable information.

“This study contributes significantly to our understanding of how pandemic stress might impact our brain and behavior,” Dr. Quan said. “The main advance that this paper provides is that fatigue or brain fog could be induced in individuals with COVID infection during the pandemic.”

However, Dr. Quan added, the study has a number of limitations, including a small sample size, which makes it difficult to generalize the results.

“Another issue is the subjects of the study all lived in Massachusetts,” Dr. Quan added. “Subjects from different states or different countries could yield different results.”

The study was funded by the National Institutes of Health and by the Landreth Family Foundation. The study authors and Dr. Quan have disclosed no relevant financial relationships.

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

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

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

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

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

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

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

I don’t have a patient portal. Probably never will.

This isn’t an attempt at “information blocking,” or intentional noncompliance, or a rebellious streak against the CURES act.

It’s practical: I can’t afford it.

I’m a small one-doc practice. My overhead is high, my profit margin is razor thin. In the sudden spike of COVID-19– and war-related inflation, my gas and office supply costs have gone up, but I’m in a field where I can’t raise my own prices to compensate. The restaurants and grocery stores near me can, but I can’t because of the way insurance works.

With that background, I don’t have the money to set up a patient portal for people to be able to get their notes, test results, anything.

This isn’t to say that I withhold things from patients. If they want a copy of my note, or their MRI report, or whatever, they’re welcome to it. I’m happy to fax it to them, or put it in the mail, or have them come by and pick it up.

I have no desire to keep information from patients. I actually try to stay on top of it, calling them with test results within 24 hours of receiving them and arranging follow-ups quickly when needed.

That’s one of the pluses of my dinky practice – I generally know my patients and can make decisions quickly on the next step once results come in. They don’t get tossed in a box to be reviewed in a few days. I take pride in staying on top of things – isn’t that how we all want to be treated when we’re on the other side of the desk?

Politicians like to say how much America depends on small businesses and how important we are to the economy. They love to do photo ops at a newly opened ice cream place or small barbecue joint. But if you’re a doctor in a small practice, you often get treated the same way the Mega-Med Group (“287 doctors! 19 specialties! 37 offices! No waiting!”) is treated. They can afford to have a digital portal, so why can’t you?

Just because I don’t have a patient portal, though, doesn’t mean I’m hiding things from patients.

Or not doing my best to care for them.

Like Avis, I may not be No. 1, but I sure try harder.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I don’t have a patient portal. Probably never will.

This isn’t an attempt at “information blocking,” or intentional noncompliance, or a rebellious streak against the CURES act.

It’s practical: I can’t afford it.

I’m a small one-doc practice. My overhead is high, my profit margin is razor thin. In the sudden spike of COVID-19– and war-related inflation, my gas and office supply costs have gone up, but I’m in a field where I can’t raise my own prices to compensate. The restaurants and grocery stores near me can, but I can’t because of the way insurance works.

With that background, I don’t have the money to set up a patient portal for people to be able to get their notes, test results, anything.

This isn’t to say that I withhold things from patients. If they want a copy of my note, or their MRI report, or whatever, they’re welcome to it. I’m happy to fax it to them, or put it in the mail, or have them come by and pick it up.

I have no desire to keep information from patients. I actually try to stay on top of it, calling them with test results within 24 hours of receiving them and arranging follow-ups quickly when needed.

That’s one of the pluses of my dinky practice – I generally know my patients and can make decisions quickly on the next step once results come in. They don’t get tossed in a box to be reviewed in a few days. I take pride in staying on top of things – isn’t that how we all want to be treated when we’re on the other side of the desk?

Politicians like to say how much America depends on small businesses and how important we are to the economy. They love to do photo ops at a newly opened ice cream place or small barbecue joint. But if you’re a doctor in a small practice, you often get treated the same way the Mega-Med Group (“287 doctors! 19 specialties! 37 offices! No waiting!”) is treated. They can afford to have a digital portal, so why can’t you?

Just because I don’t have a patient portal, though, doesn’t mean I’m hiding things from patients.

Or not doing my best to care for them.

Like Avis, I may not be No. 1, but I sure try harder.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I don’t have a patient portal. Probably never will.

This isn’t an attempt at “information blocking,” or intentional noncompliance, or a rebellious streak against the CURES act.

It’s practical: I can’t afford it.

I’m a small one-doc practice. My overhead is high, my profit margin is razor thin. In the sudden spike of COVID-19– and war-related inflation, my gas and office supply costs have gone up, but I’m in a field where I can’t raise my own prices to compensate. The restaurants and grocery stores near me can, but I can’t because of the way insurance works.

With that background, I don’t have the money to set up a patient portal for people to be able to get their notes, test results, anything.

This isn’t to say that I withhold things from patients. If they want a copy of my note, or their MRI report, or whatever, they’re welcome to it. I’m happy to fax it to them, or put it in the mail, or have them come by and pick it up.

I have no desire to keep information from patients. I actually try to stay on top of it, calling them with test results within 24 hours of receiving them and arranging follow-ups quickly when needed.

That’s one of the pluses of my dinky practice – I generally know my patients and can make decisions quickly on the next step once results come in. They don’t get tossed in a box to be reviewed in a few days. I take pride in staying on top of things – isn’t that how we all want to be treated when we’re on the other side of the desk?

Politicians like to say how much America depends on small businesses and how important we are to the economy. They love to do photo ops at a newly opened ice cream place or small barbecue joint. But if you’re a doctor in a small practice, you often get treated the same way the Mega-Med Group (“287 doctors! 19 specialties! 37 offices! No waiting!”) is treated. They can afford to have a digital portal, so why can’t you?

Just because I don’t have a patient portal, though, doesn’t mean I’m hiding things from patients.

Or not doing my best to care for them.

Like Avis, I may not be No. 1, but I sure try harder.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Differing state regulations and a paucity of research has made it difficult to develop consensus guidelines for the use of cannabinoids in treating drug-resistant epilepsy. A recent review article draws from existing clinical trials and clinical experience in New South Wales, Australia, to fill this gap with interim guidance for both pediatric and adult patients. The article was published in the British Journal of Clinical Pharmacology.

The only current U.S. guidelines are from the American Academy of Neurology’s position statement on the use of medical cannabis for neurologic disorders and the American Epilepsy Society’s position statement on cannabis as a treatment for epileptic seizures. The AAN statement “highlights the current evidence, which currently only supports [Food and Drug Administration]–approved CBD [cannabidiol] (Epidiolex) for specific epilepsy syndromes,” said Daniel Freedman, DO, an assistant professor of neurology at the University of Texas at Austin and coauthor of the AAN’s position statement.

“Rescheduling marijuana will enable researchers to study CBD, THC [tetrahydrocannabinol], and other cannabinoids in high-quality studies so that we can better understand what works and for which conditions,” said Dr. Freedman, who was not involved in the Australian guidance document. He noted that little consensus exists because little evidence exists outside the handful of trials for Epidiolex.

“There are some patients with epilepsy that can benefit from high-quality, pharmaceutical-grade CBD products,” Dr. Freedman said. “These patients need to be carefully identified by a neurologist or epileptologist and prescribed a legal, safe, quality-controlled, and FDA-regulated product.”
 

Appropriate patient populations

Drug-resistant epilepsy, defined as failure of two appropriate antiseizure medications, affects an estimated one third of people with epilepsy, the new guideline notes. Though many over-the-counter products are available at dispensaries in the 33 U.S. states that allow use of cannabis for medical purposes, Epidiolex (cannabidiol) is the only FDA-approved drug for epilepsy that contains a substance derived from cannabis and the only one for which evidence from randomized, controlled trials exists.

Dr. Freedman notes that hemp-derived CBD oils are classified differently in the United States than marijuana-derived CBD oil, including Epidiolex, and are loosely regulated supplements or food additives commonly seen, for example at gas station.

“The point I drive home to patients is that you wouldn’t get your antibiotics from a gas station, so please don’t get your seizure medication from there,” Dr. Freedman said. “Studies have been done on ‘over-the-counter’ CBD oils and shown that they have variable quality, sometimes no detectable CBD, and sometimes other chemicals added like THC.”

Studies of Epidiolex showed that cannabidiol more effectively reduced seizure frequency than placebo for pediatric patients with Dravet syndrome (42% reduction) and for pediatric and adult patients with Lennox-Gastaut syndrome (39% reduction) or tuberous sclerosis complex (49% reduction). Efficacy was similar across dosing from 10-50 mg/kg per day, but higher doses involved higher rates of serious adverse events.

No reliable evidence in humans exists for THC or other cannabinoids in treating epilepsy.

The Australian guidance recommends limiting cannabis treatment to patients with severe drug-resistant epilepsy; a diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or tuberous sclerosis complex; and previous treatment with four approved antiseizure medications and/or the ketogenic diet, epilepsy surgery, or neurostimulator. The authors provide specific criteria for each of these conditions and then address exceptional cases that may be considered outside that criteria, such as patients under 2 years old, severe epilepsy with extended or repeated hospitalization or ICU admission, or a dangerous seizure type. The review also includes a detailed list of exclusion criteria for CBD medicine use.

The authors advised a thorough consent process before prescribing any cannabinoids, including therapeutic goals and stopping criteria; the lack of evidence available on dosing, efficacy, and side effects; and the potential for dependence or withdrawal. Consent discussions should also note whether the products are unregistered and not covered by external payers (anything other than Epidiolex currently), any activity restrictions, and any implications for occupational drug screening.
 

Considerations for unapproved cannabinoids

The authors note several factors to consider if prescribing or recommending a nonapproved, nonregulated cannabis medicine, including the ”differences between registered plant-derived cannabis medicines, synthetic cannabis medicines, and unregistered hemp-derived products.” Epidiolex is plant derived while other cannabis-derived medications (Marinol, Syndos, and Cesamet) that have been approved for nonepilepsy conditions, such as nausea associated with chemotherapy, are synthetic.

The guidance document notes several reasons to use a regulated medication instead of an unregulated product:

• Manufacturing processes can differ for unregulated products, including inconsistency in batches and unknown shelf life.
• Quality control processes, including risk of impurities, are much better with regulated products, which also have a system in place for safety recalls.
• More scientific evidence is available for regulated products.
• Safety surveillance reporting is more robust and standardized for regulated products whereas adverse event reporting is less reliable for unregulated products.
• Nonregulated products are rarely covered by insurance or other reimbursement.

Legal considerations will also vary by jurisdiction. ”Right now in the U.S. we have a confused legality where state level programs are still technically illegal at the federal level and I imagine there are some quality differences amongst dispensaries and states,” Dr. Freedman said. “Whenever there is disagreement between state and federal laws, this creates tension for our patients.” He noted, for example, that a patient using a CBD product that contains THC may, even if legal in their state, be confiscated by the Transportation Security Administration at an airport since it is not FDA approved and is not legal, according to the Drug Enforcement Agency.

The authors noted that inadequate data on long-term CBD use and data on neurodevelopmental effects of THC in children, teens, and young adults means THC products should be contraindicated for these age groups. (Epidiolex has less than 2% THC.) Drug interactions should also be considered, particularly for clobazam, CYP3A4 inhibitors or inducers (including St. John’s wort), digoxin, or a mechanistic target of rapamycin inhibitor.

Dr. Freedman said that most neurologists are comfortable prescribing Epidiolex since it has FDA approval while prescribing unapproved products varies more in the field. “Now that many states have compassionate use programs for medical marijuana, some neurologists do this as well,” Dr. Freedman said. Patients often ask about unregulated CBD or CBD+THC products because they’re seen as “natural and therefore better than manufactured pharmaceuticals.”

“I think this is the naturalistic fallacy at work and try to educate my patients on that since our only high-level data to show marijuana products work for epilepsy comes from a pharmaceutical company,” Dr. Freedman said. “My reasons for hesitating on compassionate use are that there is often THC, with variable amounts of concentration, and we know that THC can harm the developing pediatric brain.”
 

Dosing and adverse effects

Pediatric and adult dosing differences need to be considered, and “patient response (efficacy and toxicity) to these medications varies widely,” the authors noted. They advised getting serum transaminases (ALT and AST) and total bilirubin levels before beginning treatment. All patients should begin Epidiolex at a low dose, such as 2-5 mg/kg per day of CBD in two divided doses, the authors advise, and titrate slowly while monitoring for side effects (no more than 5 mg/kg per day per week). The current dosing range for CBD is 5-20 mg/kg per day in two divided doses, with higher rates involving more risk of adverse events.

“Note that some cannabinoids auto-inhibit their own metabolism and some have active metabolites with longer half-lives,” the authors wrote. “Therefore, dose or frequency may need to be reduced over time, unless tolerance occurs.” These doses, specific to Epidiolex, “cannot necessarily be applied to other oral CBD formulations or other types of epilepsy.” This guidance also does not apply to inhaled or transdermal routes of administration.

The most common adverse events were sleepiness – which occurred in up to 60% of trial participants – as well as diarrhea, decreases in appetite and weight, and drug interactions. Risk of hepatotoxicity means there’s a need to monitor liver function and adjust dosing for patients with moderate or severe hepatic impairment. “Other short-term side effects reported only with THC-containing cannabinoid compounds include increased risk of cardiac and cerebrovascular events, anxiety and psychosis risk, dependency, and withdrawal,” the authors wrote.

Though no withdrawal syndrome has been linked to stopping CBD, the authors suggested decreasing the dose by 10% every 2 days if stopping is not urgent.

“The key points to this issue are that CBD and all marijuana products need to be safe and regulated,” Dr. Freedman said. “Any claims about them need to be backed by high-quality evidence looking at that specific product for that specific condition.”

Dr. Freedman noted the need for children to receive treatment from clinicians with expertise in their specific condition since many other evidence-based treatments exist even for patients with epilepsy syndromes that are difficult to treat, such as other medications, surgery, and specialized diets.

“We need to fix the inconsistent regulation between over-the-counter CBD products, state dispensaries, and federal laws,” Dr. Freedman added. “Any medicine being used to treat children should be held to the same FDA standard of safety and efficacy.”

Dr. Freedman and the authors had no conflicts of interest. No external funding was noted.

Differing state regulations and a paucity of research has made it difficult to develop consensus guidelines for the use of cannabinoids in treating drug-resistant epilepsy. A recent review article draws from existing clinical trials and clinical experience in New South Wales, Australia, to fill this gap with interim guidance for both pediatric and adult patients. The article was published in the British Journal of Clinical Pharmacology.

The only current U.S. guidelines are from the American Academy of Neurology’s position statement on the use of medical cannabis for neurologic disorders and the American Epilepsy Society’s position statement on cannabis as a treatment for epileptic seizures. The AAN statement “highlights the current evidence, which currently only supports [Food and Drug Administration]–approved CBD [cannabidiol] (Epidiolex) for specific epilepsy syndromes,” said Daniel Freedman, DO, an assistant professor of neurology at the University of Texas at Austin and coauthor of the AAN’s position statement.

“Rescheduling marijuana will enable researchers to study CBD, THC [tetrahydrocannabinol], and other cannabinoids in high-quality studies so that we can better understand what works and for which conditions,” said Dr. Freedman, who was not involved in the Australian guidance document. He noted that little consensus exists because little evidence exists outside the handful of trials for Epidiolex.

“There are some patients with epilepsy that can benefit from high-quality, pharmaceutical-grade CBD products,” Dr. Freedman said. “These patients need to be carefully identified by a neurologist or epileptologist and prescribed a legal, safe, quality-controlled, and FDA-regulated product.”
 

Appropriate patient populations

Drug-resistant epilepsy, defined as failure of two appropriate antiseizure medications, affects an estimated one third of people with epilepsy, the new guideline notes. Though many over-the-counter products are available at dispensaries in the 33 U.S. states that allow use of cannabis for medical purposes, Epidiolex (cannabidiol) is the only FDA-approved drug for epilepsy that contains a substance derived from cannabis and the only one for which evidence from randomized, controlled trials exists.

Dr. Freedman notes that hemp-derived CBD oils are classified differently in the United States than marijuana-derived CBD oil, including Epidiolex, and are loosely regulated supplements or food additives commonly seen, for example at gas station.

“The point I drive home to patients is that you wouldn’t get your antibiotics from a gas station, so please don’t get your seizure medication from there,” Dr. Freedman said. “Studies have been done on ‘over-the-counter’ CBD oils and shown that they have variable quality, sometimes no detectable CBD, and sometimes other chemicals added like THC.”

Studies of Epidiolex showed that cannabidiol more effectively reduced seizure frequency than placebo for pediatric patients with Dravet syndrome (42% reduction) and for pediatric and adult patients with Lennox-Gastaut syndrome (39% reduction) or tuberous sclerosis complex (49% reduction). Efficacy was similar across dosing from 10-50 mg/kg per day, but higher doses involved higher rates of serious adverse events.

No reliable evidence in humans exists for THC or other cannabinoids in treating epilepsy.

The Australian guidance recommends limiting cannabis treatment to patients with severe drug-resistant epilepsy; a diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or tuberous sclerosis complex; and previous treatment with four approved antiseizure medications and/or the ketogenic diet, epilepsy surgery, or neurostimulator. The authors provide specific criteria for each of these conditions and then address exceptional cases that may be considered outside that criteria, such as patients under 2 years old, severe epilepsy with extended or repeated hospitalization or ICU admission, or a dangerous seizure type. The review also includes a detailed list of exclusion criteria for CBD medicine use.

The authors advised a thorough consent process before prescribing any cannabinoids, including therapeutic goals and stopping criteria; the lack of evidence available on dosing, efficacy, and side effects; and the potential for dependence or withdrawal. Consent discussions should also note whether the products are unregistered and not covered by external payers (anything other than Epidiolex currently), any activity restrictions, and any implications for occupational drug screening.
 

Considerations for unapproved cannabinoids

The authors note several factors to consider if prescribing or recommending a nonapproved, nonregulated cannabis medicine, including the ”differences between registered plant-derived cannabis medicines, synthetic cannabis medicines, and unregistered hemp-derived products.” Epidiolex is plant derived while other cannabis-derived medications (Marinol, Syndos, and Cesamet) that have been approved for nonepilepsy conditions, such as nausea associated with chemotherapy, are synthetic.

The guidance document notes several reasons to use a regulated medication instead of an unregulated product:

• Manufacturing processes can differ for unregulated products, including inconsistency in batches and unknown shelf life.
• Quality control processes, including risk of impurities, are much better with regulated products, which also have a system in place for safety recalls.
• More scientific evidence is available for regulated products.
• Safety surveillance reporting is more robust and standardized for regulated products whereas adverse event reporting is less reliable for unregulated products.
• Nonregulated products are rarely covered by insurance or other reimbursement.

Legal considerations will also vary by jurisdiction. ”Right now in the U.S. we have a confused legality where state level programs are still technically illegal at the federal level and I imagine there are some quality differences amongst dispensaries and states,” Dr. Freedman said. “Whenever there is disagreement between state and federal laws, this creates tension for our patients.” He noted, for example, that a patient using a CBD product that contains THC may, even if legal in their state, be confiscated by the Transportation Security Administration at an airport since it is not FDA approved and is not legal, according to the Drug Enforcement Agency.

The authors noted that inadequate data on long-term CBD use and data on neurodevelopmental effects of THC in children, teens, and young adults means THC products should be contraindicated for these age groups. (Epidiolex has less than 2% THC.) Drug interactions should also be considered, particularly for clobazam, CYP3A4 inhibitors or inducers (including St. John’s wort), digoxin, or a mechanistic target of rapamycin inhibitor.

Dr. Freedman said that most neurologists are comfortable prescribing Epidiolex since it has FDA approval while prescribing unapproved products varies more in the field. “Now that many states have compassionate use programs for medical marijuana, some neurologists do this as well,” Dr. Freedman said. Patients often ask about unregulated CBD or CBD+THC products because they’re seen as “natural and therefore better than manufactured pharmaceuticals.”

“I think this is the naturalistic fallacy at work and try to educate my patients on that since our only high-level data to show marijuana products work for epilepsy comes from a pharmaceutical company,” Dr. Freedman said. “My reasons for hesitating on compassionate use are that there is often THC, with variable amounts of concentration, and we know that THC can harm the developing pediatric brain.”
 

Dosing and adverse effects

Pediatric and adult dosing differences need to be considered, and “patient response (efficacy and toxicity) to these medications varies widely,” the authors noted. They advised getting serum transaminases (ALT and AST) and total bilirubin levels before beginning treatment. All patients should begin Epidiolex at a low dose, such as 2-5 mg/kg per day of CBD in two divided doses, the authors advise, and titrate slowly while monitoring for side effects (no more than 5 mg/kg per day per week). The current dosing range for CBD is 5-20 mg/kg per day in two divided doses, with higher rates involving more risk of adverse events.

“Note that some cannabinoids auto-inhibit their own metabolism and some have active metabolites with longer half-lives,” the authors wrote. “Therefore, dose or frequency may need to be reduced over time, unless tolerance occurs.” These doses, specific to Epidiolex, “cannot necessarily be applied to other oral CBD formulations or other types of epilepsy.” This guidance also does not apply to inhaled or transdermal routes of administration.

The most common adverse events were sleepiness – which occurred in up to 60% of trial participants – as well as diarrhea, decreases in appetite and weight, and drug interactions. Risk of hepatotoxicity means there’s a need to monitor liver function and adjust dosing for patients with moderate or severe hepatic impairment. “Other short-term side effects reported only with THC-containing cannabinoid compounds include increased risk of cardiac and cerebrovascular events, anxiety and psychosis risk, dependency, and withdrawal,” the authors wrote.

Though no withdrawal syndrome has been linked to stopping CBD, the authors suggested decreasing the dose by 10% every 2 days if stopping is not urgent.

“The key points to this issue are that CBD and all marijuana products need to be safe and regulated,” Dr. Freedman said. “Any claims about them need to be backed by high-quality evidence looking at that specific product for that specific condition.”

Dr. Freedman noted the need for children to receive treatment from clinicians with expertise in their specific condition since many other evidence-based treatments exist even for patients with epilepsy syndromes that are difficult to treat, such as other medications, surgery, and specialized diets.

“We need to fix the inconsistent regulation between over-the-counter CBD products, state dispensaries, and federal laws,” Dr. Freedman added. “Any medicine being used to treat children should be held to the same FDA standard of safety and efficacy.”

Dr. Freedman and the authors had no conflicts of interest. No external funding was noted.

Differing state regulations and a paucity of research has made it difficult to develop consensus guidelines for the use of cannabinoids in treating drug-resistant epilepsy. A recent review article draws from existing clinical trials and clinical experience in New South Wales, Australia, to fill this gap with interim guidance for both pediatric and adult patients. The article was published in the British Journal of Clinical Pharmacology.

The only current U.S. guidelines are from the American Academy of Neurology’s position statement on the use of medical cannabis for neurologic disorders and the American Epilepsy Society’s position statement on cannabis as a treatment for epileptic seizures. The AAN statement “highlights the current evidence, which currently only supports [Food and Drug Administration]–approved CBD [cannabidiol] (Epidiolex) for specific epilepsy syndromes,” said Daniel Freedman, DO, an assistant professor of neurology at the University of Texas at Austin and coauthor of the AAN’s position statement.

“Rescheduling marijuana will enable researchers to study CBD, THC [tetrahydrocannabinol], and other cannabinoids in high-quality studies so that we can better understand what works and for which conditions,” said Dr. Freedman, who was not involved in the Australian guidance document. He noted that little consensus exists because little evidence exists outside the handful of trials for Epidiolex.

“There are some patients with epilepsy that can benefit from high-quality, pharmaceutical-grade CBD products,” Dr. Freedman said. “These patients need to be carefully identified by a neurologist or epileptologist and prescribed a legal, safe, quality-controlled, and FDA-regulated product.”
 

Appropriate patient populations

Drug-resistant epilepsy, defined as failure of two appropriate antiseizure medications, affects an estimated one third of people with epilepsy, the new guideline notes. Though many over-the-counter products are available at dispensaries in the 33 U.S. states that allow use of cannabis for medical purposes, Epidiolex (cannabidiol) is the only FDA-approved drug for epilepsy that contains a substance derived from cannabis and the only one for which evidence from randomized, controlled trials exists.

Dr. Freedman notes that hemp-derived CBD oils are classified differently in the United States than marijuana-derived CBD oil, including Epidiolex, and are loosely regulated supplements or food additives commonly seen, for example at gas station.

“The point I drive home to patients is that you wouldn’t get your antibiotics from a gas station, so please don’t get your seizure medication from there,” Dr. Freedman said. “Studies have been done on ‘over-the-counter’ CBD oils and shown that they have variable quality, sometimes no detectable CBD, and sometimes other chemicals added like THC.”

Studies of Epidiolex showed that cannabidiol more effectively reduced seizure frequency than placebo for pediatric patients with Dravet syndrome (42% reduction) and for pediatric and adult patients with Lennox-Gastaut syndrome (39% reduction) or tuberous sclerosis complex (49% reduction). Efficacy was similar across dosing from 10-50 mg/kg per day, but higher doses involved higher rates of serious adverse events.

No reliable evidence in humans exists for THC or other cannabinoids in treating epilepsy.

The Australian guidance recommends limiting cannabis treatment to patients with severe drug-resistant epilepsy; a diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or tuberous sclerosis complex; and previous treatment with four approved antiseizure medications and/or the ketogenic diet, epilepsy surgery, or neurostimulator. The authors provide specific criteria for each of these conditions and then address exceptional cases that may be considered outside that criteria, such as patients under 2 years old, severe epilepsy with extended or repeated hospitalization or ICU admission, or a dangerous seizure type. The review also includes a detailed list of exclusion criteria for CBD medicine use.

The authors advised a thorough consent process before prescribing any cannabinoids, including therapeutic goals and stopping criteria; the lack of evidence available on dosing, efficacy, and side effects; and the potential for dependence or withdrawal. Consent discussions should also note whether the products are unregistered and not covered by external payers (anything other than Epidiolex currently), any activity restrictions, and any implications for occupational drug screening.
 

Considerations for unapproved cannabinoids

The authors note several factors to consider if prescribing or recommending a nonapproved, nonregulated cannabis medicine, including the ”differences between registered plant-derived cannabis medicines, synthetic cannabis medicines, and unregistered hemp-derived products.” Epidiolex is plant derived while other cannabis-derived medications (Marinol, Syndos, and Cesamet) that have been approved for nonepilepsy conditions, such as nausea associated with chemotherapy, are synthetic.

The guidance document notes several reasons to use a regulated medication instead of an unregulated product:

• Manufacturing processes can differ for unregulated products, including inconsistency in batches and unknown shelf life.
• Quality control processes, including risk of impurities, are much better with regulated products, which also have a system in place for safety recalls.
• More scientific evidence is available for regulated products.
• Safety surveillance reporting is more robust and standardized for regulated products whereas adverse event reporting is less reliable for unregulated products.
• Nonregulated products are rarely covered by insurance or other reimbursement.

Legal considerations will also vary by jurisdiction. ”Right now in the U.S. we have a confused legality where state level programs are still technically illegal at the federal level and I imagine there are some quality differences amongst dispensaries and states,” Dr. Freedman said. “Whenever there is disagreement between state and federal laws, this creates tension for our patients.” He noted, for example, that a patient using a CBD product that contains THC may, even if legal in their state, be confiscated by the Transportation Security Administration at an airport since it is not FDA approved and is not legal, according to the Drug Enforcement Agency.

The authors noted that inadequate data on long-term CBD use and data on neurodevelopmental effects of THC in children, teens, and young adults means THC products should be contraindicated for these age groups. (Epidiolex has less than 2% THC.) Drug interactions should also be considered, particularly for clobazam, CYP3A4 inhibitors or inducers (including St. John’s wort), digoxin, or a mechanistic target of rapamycin inhibitor.

Dr. Freedman said that most neurologists are comfortable prescribing Epidiolex since it has FDA approval while prescribing unapproved products varies more in the field. “Now that many states have compassionate use programs for medical marijuana, some neurologists do this as well,” Dr. Freedman said. Patients often ask about unregulated CBD or CBD+THC products because they’re seen as “natural and therefore better than manufactured pharmaceuticals.”

“I think this is the naturalistic fallacy at work and try to educate my patients on that since our only high-level data to show marijuana products work for epilepsy comes from a pharmaceutical company,” Dr. Freedman said. “My reasons for hesitating on compassionate use are that there is often THC, with variable amounts of concentration, and we know that THC can harm the developing pediatric brain.”
 

Dosing and adverse effects

Pediatric and adult dosing differences need to be considered, and “patient response (efficacy and toxicity) to these medications varies widely,” the authors noted. They advised getting serum transaminases (ALT and AST) and total bilirubin levels before beginning treatment. All patients should begin Epidiolex at a low dose, such as 2-5 mg/kg per day of CBD in two divided doses, the authors advise, and titrate slowly while monitoring for side effects (no more than 5 mg/kg per day per week). The current dosing range for CBD is 5-20 mg/kg per day in two divided doses, with higher rates involving more risk of adverse events.

“Note that some cannabinoids auto-inhibit their own metabolism and some have active metabolites with longer half-lives,” the authors wrote. “Therefore, dose or frequency may need to be reduced over time, unless tolerance occurs.” These doses, specific to Epidiolex, “cannot necessarily be applied to other oral CBD formulations or other types of epilepsy.” This guidance also does not apply to inhaled or transdermal routes of administration.

The most common adverse events were sleepiness – which occurred in up to 60% of trial participants – as well as diarrhea, decreases in appetite and weight, and drug interactions. Risk of hepatotoxicity means there’s a need to monitor liver function and adjust dosing for patients with moderate or severe hepatic impairment. “Other short-term side effects reported only with THC-containing cannabinoid compounds include increased risk of cardiac and cerebrovascular events, anxiety and psychosis risk, dependency, and withdrawal,” the authors wrote.

Though no withdrawal syndrome has been linked to stopping CBD, the authors suggested decreasing the dose by 10% every 2 days if stopping is not urgent.

“The key points to this issue are that CBD and all marijuana products need to be safe and regulated,” Dr. Freedman said. “Any claims about them need to be backed by high-quality evidence looking at that specific product for that specific condition.”

Dr. Freedman noted the need for children to receive treatment from clinicians with expertise in their specific condition since many other evidence-based treatments exist even for patients with epilepsy syndromes that are difficult to treat, such as other medications, surgery, and specialized diets.

“We need to fix the inconsistent regulation between over-the-counter CBD products, state dispensaries, and federal laws,” Dr. Freedman added. “Any medicine being used to treat children should be held to the same FDA standard of safety and efficacy.”

Dr. Freedman and the authors had no conflicts of interest. No external funding was noted.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.

There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.

Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.

We’re not here to debate the merits and demerits of this terrible act of war. One issue that’s come up that doctors and scientists face is whether they should be cooperating with Russian scientific societies, Russian doctors, and Russian scientists.

The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.

The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.

Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.

I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.

They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.

The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”

There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.

I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.

What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.

I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.

It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.

We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.

Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
 

Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.

There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.

Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.

We’re not here to debate the merits and demerits of this terrible act of war. One issue that’s come up that doctors and scientists face is whether they should be cooperating with Russian scientific societies, Russian doctors, and Russian scientists.

The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.

The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.

Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.

I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.

They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.

The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”

There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.

I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.

What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.

I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.

It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.

We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.

Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
 

Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.

There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.

Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.

We’re not here to debate the merits and demerits of this terrible act of war. One issue that’s come up that doctors and scientists face is whether they should be cooperating with Russian scientific societies, Russian doctors, and Russian scientists.

The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.

The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.

Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.

I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.

They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.

The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”

There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.

I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.

What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.

I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.

It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.

We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.

Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
 

Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

Dr Enrique Alvarez, Associate Professor at the University of Colorado, reviews updates in symptom management that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.

First, Dr Alvarez highlights two studies of nabiximols — a complex botanical mixture of tetrahydrocannabinol and cannabidiol — in patients with multiple sclerosis (MS). In both the GWSP0604 and SAVANT studies, patients taking nabiximols demonstrated significant spasticity improvement and reductions in spasm frequency.

Next, Dr Alvarez shares study results that compared patient responses to the responses of healthcare practitioners (HCPs) treating these patients for their MS. This analysis, which focused on cases of fatigue, mood, and cognition, found that patients reported significantly higher rates of these symptoms compared with HCP responses.

Another study assessed the importance of shared decision-making between HCPs and patients with MS, drawing from MEDLINE, EMBASE, and CINAHL databases. The researchers identified apparent challenges in patient education and access to information and recommended that shared decision-making be integrated into routine practice.

Dr Alvarez concludes with a review of new resources launched by the National Multiple Sclerosis Society, the goal of which is to inform and empower patients about dietary approaches for self-management and to support clinicians who are facilitating related discussions with their patients.

--

Enrique Alvarez, MD, PhD, Vice Chair of Clinical Research, Associate Professor, Department of Neurology, Division Neuroimmunology, University of Colorado, Rocky Mountain MS Center Anschutz Medical Center, Aurora, Colorado

Enrique Alvarez, MD, PhD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Genentech/Roche; Novartis; TG Therapeutics; Patient-Centered Outcomes Research Initiative; National Multiple Sclerosis Society; National Institutes of Health; Rocky Mountain MS Center

Received income in an amount equal to or greater than $250 from: Actelion

Dr Enrique Alvarez, Associate Professor at the University of Colorado, reviews updates in symptom management that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.

First, Dr Alvarez highlights two studies of nabiximols — a complex botanical mixture of tetrahydrocannabinol and cannabidiol — in patients with multiple sclerosis (MS). In both the GWSP0604 and SAVANT studies, patients taking nabiximols demonstrated significant spasticity improvement and reductions in spasm frequency.

Next, Dr Alvarez shares study results that compared patient responses to the responses of healthcare practitioners (HCPs) treating these patients for their MS. This analysis, which focused on cases of fatigue, mood, and cognition, found that patients reported significantly higher rates of these symptoms compared with HCP responses.

Another study assessed the importance of shared decision-making between HCPs and patients with MS, drawing from MEDLINE, EMBASE, and CINAHL databases. The researchers identified apparent challenges in patient education and access to information and recommended that shared decision-making be integrated into routine practice.

Dr Alvarez concludes with a review of new resources launched by the National Multiple Sclerosis Society, the goal of which is to inform and empower patients about dietary approaches for self-management and to support clinicians who are facilitating related discussions with their patients.

--

Enrique Alvarez, MD, PhD, Vice Chair of Clinical Research, Associate Professor, Department of Neurology, Division Neuroimmunology, University of Colorado, Rocky Mountain MS Center Anschutz Medical Center, Aurora, Colorado

Enrique Alvarez, MD, PhD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Genentech/Roche; Novartis; TG Therapeutics; Patient-Centered Outcomes Research Initiative; National Multiple Sclerosis Society; National Institutes of Health; Rocky Mountain MS Center

Received income in an amount equal to or greater than $250 from: Actelion

Dr Enrique Alvarez, Associate Professor at the University of Colorado, reviews updates in symptom management that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.

First, Dr Alvarez highlights two studies of nabiximols — a complex botanical mixture of tetrahydrocannabinol and cannabidiol — in patients with multiple sclerosis (MS). In both the GWSP0604 and SAVANT studies, patients taking nabiximols demonstrated significant spasticity improvement and reductions in spasm frequency.

Next, Dr Alvarez shares study results that compared patient responses to the responses of healthcare practitioners (HCPs) treating these patients for their MS. This analysis, which focused on cases of fatigue, mood, and cognition, found that patients reported significantly higher rates of these symptoms compared with HCP responses.

Another study assessed the importance of shared decision-making between HCPs and patients with MS, drawing from MEDLINE, EMBASE, and CINAHL databases. The researchers identified apparent challenges in patient education and access to information and recommended that shared decision-making be integrated into routine practice.

Dr Alvarez concludes with a review of new resources launched by the National Multiple Sclerosis Society, the goal of which is to inform and empower patients about dietary approaches for self-management and to support clinicians who are facilitating related discussions with their patients.

--

Enrique Alvarez, MD, PhD, Vice Chair of Clinical Research, Associate Professor, Department of Neurology, Division Neuroimmunology, University of Colorado, Rocky Mountain MS Center Anschutz Medical Center, Aurora, Colorado

Enrique Alvarez, MD, PhD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Genentech/Roche; Novartis; TG Therapeutics; Patient-Centered Outcomes Research Initiative; National Multiple Sclerosis Society; National Institutes of Health; Rocky Mountain MS Center

Received income in an amount equal to or greater than $250 from: Actelion

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

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