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The changing brain signature of HIV
“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.
The study was published online Jan. 15 in JAMA Network Open.
Brain signature of HIV
The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.
These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.
In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.
Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.
The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.
“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”
A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.
This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.
“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.
“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.
Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.
A version of this article first appeared on Medscape.com.
“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.
The study was published online Jan. 15 in JAMA Network Open.
Brain signature of HIV
The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.
These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.
In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.
Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.
The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.
“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”
A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.
This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.
“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.
“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.
Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.
A version of this article first appeared on Medscape.com.
“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.
The study was published online Jan. 15 in JAMA Network Open.
Brain signature of HIV
The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.
These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.
In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.
Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.
The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.
“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”
A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.
This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.
“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.
“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.
Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.
A version of this article first appeared on Medscape.com.
Steroid and immunoglobulin standard of care for MIS-C
The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.
“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”
Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.
A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.
Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.
Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.
But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.
Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.
The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.
Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).
Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).
There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.
The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”
In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.
The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.
This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.
Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.
The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.
“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”
Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.
A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.
Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.
Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.
But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.
Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.
The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.
Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).
Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).
There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.
The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”
In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.
The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.
This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.
Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.
The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.
“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”
Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.
A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.
Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.
Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.
But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.
Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.
The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.
Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).
Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).
There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.
The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”
In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.
The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.
This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.
Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.
The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Lifestyle coaching for obesity associated with improved cardiometabolic numbers in study
Patients who received intensive lifestyle training by coaches in the primary care setting experienced improvement in several indicators of cardiometabolic health in a 2-year trial.
The 803 trial participants comprised a racially diverse, low-income population with obesity. In this study, primary care clinics were randomly assigned to provide weight-loss coaching or usual care. Patients at the intensive training clinics lost significantly more weight than the other patients, as reported in a paper published in September in the New England Journal of Medicine on the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) trial. The patients who received weight loss coaching also had significantly more improvement in HDL cholesterol levels, total to HDL cholesterol ratios, and metabolic syndrome severity score, said researchers in the new paper on the PROPEL trial, which was published in Circulation on February 8 .
“We believe that one reason for success of the program was the use of a health coach [who] was embedded in the primary care office,” said lead author Peter Katzmarzyk, PhD, associate executive director for population and public health sciences at the Pennington Biomedical Research Center, Baton Rouge, La. “This way, the patients could get their counseling in a familiar environment and did not have to go to a different setting. The coaches developed close relationships with the patients over the 2 years, and this helped develop a sense of responsibility in the patients as the coaches were helping the patients to set goals and kept them accountable.”
In the PROPEL study, 67% of patients were Black and had low health literacy scores that corresponded with less than a ninth-grade education level. The intensive lifestyle intervention program included weekly sessions with the trained health coaches over the first 6 months — 16 face-to-face and 6 over the phone — and then at least monthly for the last 18 months. The coaches had higher education degrees in nutrition, physical activity, or behavioral medicine. Before the program started, the coaches also received training in the management of obesity and related health issues, health literacy, and patient communication and education. The goal of the program was 10% weight loss, using personalized action plans on eating, dieting, and physical activity.
Those in the usual-care clinics continued receiving normal care and received newsletters on health topics, such as the importance of sleep and tips for limiting time spent sitting. The primary care physicians at those clinics also were given a presentation with Centers for Medicare & Medicaid Services (CMS) information on intensive lifestyle interventions for obesity.
Cholesterol changes in intervention vs. control group
HDL cholesterol improved significantly among the coached patients, compared with the other patients, with a mean difference of 4.1 mg/dL at 1 year and 4.6 mg/dL at 2 years (P less than .01 for both). The total cholesterol to HDL cholesterol ratio showed a similarly significant difference in decline, with a between-group difference of –0.29 at 1 year and –0.31 at 2 years (P less than .01 for both). Also, the difference in the change in metabolic severity scores were –0.40 at 1 year and –0.21 at 2 years (P less than .01 for both).
Fasting blood glucose had declined after the 1st year by a significantly greater degree in the clinics with coaching, compared with the others, but not after the second year, researchers found.
There were no significant differences seen in total cholesterol, LDL cholesterol, non-HDL cholesterol, or blood pressure. Dr. Katzmarzyk said the likely reason for no change in blood pressure was that it was already relatively well-controlled at baseline for all the patients.
Funding barriers to obesity treatment
The CMS currently cover intensive training for obesity if delivered directly by a primary care physician, according to the authors of the new paper. Dr. Katzmarzyk said he hopes that will change.
“We are hoping that the evidence provided in this study may change the way that CMS funds obesity treatment in the future by allowing an expansion of the care team,” he said.
John Flack, MD, chair of internal medicine at Southern Illinois University, Springfield, said that the main achievement of the study was that it showed that intensive weight-loss training in the primary-care setting could be accomplished in a racially diverse population with low health literacy.
“You can’t just automatically assume just because you’ve seen it in some other populations that you can replicate this in every population, so they’ve done a really good job,” he said.
That programs are eligible for reimbursement only if they’re run by primary-care physicians is an ongoing problem, he said.
“You don’t necessarily need to be a physician to do this,” Dr. Flack said.
For best results, payment for coaching should not be tied to office visits, Dr. Flack noted.
“If they’re de-tethered from the office visits and you’re paid for quality ... you’re going to build out your infrastructure differently to care for people,” he said.
Andrew Freeman, MD, associate professor of medicine at the University of Colorado, Denver, and cochair of the American College of Cardiology’s nutrition and lifestyle work group, said the findings dovetail with his experience.
“I’m a huge believer that when people need to make lifestyle changes, having someone hold their hand and guide them through the effort is incredibly rewarding and incredibly powerful,” said Dr. Freeman, who also oversees the intensive cardiac rehab program at National Jewish Health in Denver.
A program like this needs proper funding in order to work, Dr, Freeman noted. He added that, even with coaches being paid well, “if you are able to prevent just one readmission for, say, heart failure a month . . . you could be saving millions of dollars over just a couple of years.”
Dr. Katzmarzyk, Dr. Flack, and Dr. Freeman reported no relevant disclosures. Louisiana State University, Pennington Biomedical Research Center, and Montclair State University have interest in the intellectual property surrounding a weight graph used in the study. The other researchers reported grants and/or fees from Bayer, Boehringer Ingelheim, Gilead, Takeda, Novo Nordisk, and other companies.
Patients who received intensive lifestyle training by coaches in the primary care setting experienced improvement in several indicators of cardiometabolic health in a 2-year trial.
The 803 trial participants comprised a racially diverse, low-income population with obesity. In this study, primary care clinics were randomly assigned to provide weight-loss coaching or usual care. Patients at the intensive training clinics lost significantly more weight than the other patients, as reported in a paper published in September in the New England Journal of Medicine on the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) trial. The patients who received weight loss coaching also had significantly more improvement in HDL cholesterol levels, total to HDL cholesterol ratios, and metabolic syndrome severity score, said researchers in the new paper on the PROPEL trial, which was published in Circulation on February 8 .
“We believe that one reason for success of the program was the use of a health coach [who] was embedded in the primary care office,” said lead author Peter Katzmarzyk, PhD, associate executive director for population and public health sciences at the Pennington Biomedical Research Center, Baton Rouge, La. “This way, the patients could get their counseling in a familiar environment and did not have to go to a different setting. The coaches developed close relationships with the patients over the 2 years, and this helped develop a sense of responsibility in the patients as the coaches were helping the patients to set goals and kept them accountable.”
In the PROPEL study, 67% of patients were Black and had low health literacy scores that corresponded with less than a ninth-grade education level. The intensive lifestyle intervention program included weekly sessions with the trained health coaches over the first 6 months — 16 face-to-face and 6 over the phone — and then at least monthly for the last 18 months. The coaches had higher education degrees in nutrition, physical activity, or behavioral medicine. Before the program started, the coaches also received training in the management of obesity and related health issues, health literacy, and patient communication and education. The goal of the program was 10% weight loss, using personalized action plans on eating, dieting, and physical activity.
Those in the usual-care clinics continued receiving normal care and received newsletters on health topics, such as the importance of sleep and tips for limiting time spent sitting. The primary care physicians at those clinics also were given a presentation with Centers for Medicare & Medicaid Services (CMS) information on intensive lifestyle interventions for obesity.
Cholesterol changes in intervention vs. control group
HDL cholesterol improved significantly among the coached patients, compared with the other patients, with a mean difference of 4.1 mg/dL at 1 year and 4.6 mg/dL at 2 years (P less than .01 for both). The total cholesterol to HDL cholesterol ratio showed a similarly significant difference in decline, with a between-group difference of –0.29 at 1 year and –0.31 at 2 years (P less than .01 for both). Also, the difference in the change in metabolic severity scores were –0.40 at 1 year and –0.21 at 2 years (P less than .01 for both).
Fasting blood glucose had declined after the 1st year by a significantly greater degree in the clinics with coaching, compared with the others, but not after the second year, researchers found.
There were no significant differences seen in total cholesterol, LDL cholesterol, non-HDL cholesterol, or blood pressure. Dr. Katzmarzyk said the likely reason for no change in blood pressure was that it was already relatively well-controlled at baseline for all the patients.
Funding barriers to obesity treatment
The CMS currently cover intensive training for obesity if delivered directly by a primary care physician, according to the authors of the new paper. Dr. Katzmarzyk said he hopes that will change.
“We are hoping that the evidence provided in this study may change the way that CMS funds obesity treatment in the future by allowing an expansion of the care team,” he said.
John Flack, MD, chair of internal medicine at Southern Illinois University, Springfield, said that the main achievement of the study was that it showed that intensive weight-loss training in the primary-care setting could be accomplished in a racially diverse population with low health literacy.
“You can’t just automatically assume just because you’ve seen it in some other populations that you can replicate this in every population, so they’ve done a really good job,” he said.
That programs are eligible for reimbursement only if they’re run by primary-care physicians is an ongoing problem, he said.
“You don’t necessarily need to be a physician to do this,” Dr. Flack said.
For best results, payment for coaching should not be tied to office visits, Dr. Flack noted.
“If they’re de-tethered from the office visits and you’re paid for quality ... you’re going to build out your infrastructure differently to care for people,” he said.
Andrew Freeman, MD, associate professor of medicine at the University of Colorado, Denver, and cochair of the American College of Cardiology’s nutrition and lifestyle work group, said the findings dovetail with his experience.
“I’m a huge believer that when people need to make lifestyle changes, having someone hold their hand and guide them through the effort is incredibly rewarding and incredibly powerful,” said Dr. Freeman, who also oversees the intensive cardiac rehab program at National Jewish Health in Denver.
A program like this needs proper funding in order to work, Dr, Freeman noted. He added that, even with coaches being paid well, “if you are able to prevent just one readmission for, say, heart failure a month . . . you could be saving millions of dollars over just a couple of years.”
Dr. Katzmarzyk, Dr. Flack, and Dr. Freeman reported no relevant disclosures. Louisiana State University, Pennington Biomedical Research Center, and Montclair State University have interest in the intellectual property surrounding a weight graph used in the study. The other researchers reported grants and/or fees from Bayer, Boehringer Ingelheim, Gilead, Takeda, Novo Nordisk, and other companies.
Patients who received intensive lifestyle training by coaches in the primary care setting experienced improvement in several indicators of cardiometabolic health in a 2-year trial.
The 803 trial participants comprised a racially diverse, low-income population with obesity. In this study, primary care clinics were randomly assigned to provide weight-loss coaching or usual care. Patients at the intensive training clinics lost significantly more weight than the other patients, as reported in a paper published in September in the New England Journal of Medicine on the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) trial. The patients who received weight loss coaching also had significantly more improvement in HDL cholesterol levels, total to HDL cholesterol ratios, and metabolic syndrome severity score, said researchers in the new paper on the PROPEL trial, which was published in Circulation on February 8 .
“We believe that one reason for success of the program was the use of a health coach [who] was embedded in the primary care office,” said lead author Peter Katzmarzyk, PhD, associate executive director for population and public health sciences at the Pennington Biomedical Research Center, Baton Rouge, La. “This way, the patients could get their counseling in a familiar environment and did not have to go to a different setting. The coaches developed close relationships with the patients over the 2 years, and this helped develop a sense of responsibility in the patients as the coaches were helping the patients to set goals and kept them accountable.”
In the PROPEL study, 67% of patients were Black and had low health literacy scores that corresponded with less than a ninth-grade education level. The intensive lifestyle intervention program included weekly sessions with the trained health coaches over the first 6 months — 16 face-to-face and 6 over the phone — and then at least monthly for the last 18 months. The coaches had higher education degrees in nutrition, physical activity, or behavioral medicine. Before the program started, the coaches also received training in the management of obesity and related health issues, health literacy, and patient communication and education. The goal of the program was 10% weight loss, using personalized action plans on eating, dieting, and physical activity.
Those in the usual-care clinics continued receiving normal care and received newsletters on health topics, such as the importance of sleep and tips for limiting time spent sitting. The primary care physicians at those clinics also were given a presentation with Centers for Medicare & Medicaid Services (CMS) information on intensive lifestyle interventions for obesity.
Cholesterol changes in intervention vs. control group
HDL cholesterol improved significantly among the coached patients, compared with the other patients, with a mean difference of 4.1 mg/dL at 1 year and 4.6 mg/dL at 2 years (P less than .01 for both). The total cholesterol to HDL cholesterol ratio showed a similarly significant difference in decline, with a between-group difference of –0.29 at 1 year and –0.31 at 2 years (P less than .01 for both). Also, the difference in the change in metabolic severity scores were –0.40 at 1 year and –0.21 at 2 years (P less than .01 for both).
Fasting blood glucose had declined after the 1st year by a significantly greater degree in the clinics with coaching, compared with the others, but not after the second year, researchers found.
There were no significant differences seen in total cholesterol, LDL cholesterol, non-HDL cholesterol, or blood pressure. Dr. Katzmarzyk said the likely reason for no change in blood pressure was that it was already relatively well-controlled at baseline for all the patients.
Funding barriers to obesity treatment
The CMS currently cover intensive training for obesity if delivered directly by a primary care physician, according to the authors of the new paper. Dr. Katzmarzyk said he hopes that will change.
“We are hoping that the evidence provided in this study may change the way that CMS funds obesity treatment in the future by allowing an expansion of the care team,” he said.
John Flack, MD, chair of internal medicine at Southern Illinois University, Springfield, said that the main achievement of the study was that it showed that intensive weight-loss training in the primary-care setting could be accomplished in a racially diverse population with low health literacy.
“You can’t just automatically assume just because you’ve seen it in some other populations that you can replicate this in every population, so they’ve done a really good job,” he said.
That programs are eligible for reimbursement only if they’re run by primary-care physicians is an ongoing problem, he said.
“You don’t necessarily need to be a physician to do this,” Dr. Flack said.
For best results, payment for coaching should not be tied to office visits, Dr. Flack noted.
“If they’re de-tethered from the office visits and you’re paid for quality ... you’re going to build out your infrastructure differently to care for people,” he said.
Andrew Freeman, MD, associate professor of medicine at the University of Colorado, Denver, and cochair of the American College of Cardiology’s nutrition and lifestyle work group, said the findings dovetail with his experience.
“I’m a huge believer that when people need to make lifestyle changes, having someone hold their hand and guide them through the effort is incredibly rewarding and incredibly powerful,” said Dr. Freeman, who also oversees the intensive cardiac rehab program at National Jewish Health in Denver.
A program like this needs proper funding in order to work, Dr, Freeman noted. He added that, even with coaches being paid well, “if you are able to prevent just one readmission for, say, heart failure a month . . . you could be saving millions of dollars over just a couple of years.”
Dr. Katzmarzyk, Dr. Flack, and Dr. Freeman reported no relevant disclosures. Louisiana State University, Pennington Biomedical Research Center, and Montclair State University have interest in the intellectual property surrounding a weight graph used in the study. The other researchers reported grants and/or fees from Bayer, Boehringer Ingelheim, Gilead, Takeda, Novo Nordisk, and other companies.
COVID-19 studies funded by rheumatology foundation
Five lines of research related to COVID-19 and people with rheumatic diseases will be explored with $1.65 million awarded recently by the Rheumatology Research Foundation.
Investigators will explore topics ranging from respiratory health to telemedicine with the awards, given by the foundation that is the largest private funding source for rheumatology research and training in the United States. The projects are an attempt to deepen the understanding about how people with rheumatic illnesses are affected by COVID-19.
“Our current understanding of why there are differences in severity of COVID-19 illness among rheumatology patients is limited,” Foundation President S. Louis Bridges, MD, PhD, said. “Additionally, there are many other gaps in our knowledge of the clinical aspects of SARS-CoV-2 infection in patients with rheumatic diseases, and how the pandemic has changed health care delivery. There is an urgent need to acquire new knowledge on COVID-19 in patients with [rheumatic and musculoskeletal diseases].”
These are the research projects funded:
- Scientist Development Award: Respiratory complications of coronavirus disease (COVID-19) in rheumatic diseases, led by Kristin D’Silva, MD, of Massachusetts General Hospital in Boston (3-year, $225,000 grant)
- Scientist Development Award: COVID-19 in patients with inflammatory arthritis: A prospective study on the effects of immunomodulatory therapy on susceptibility and clinical outcomes, by Rebecca Haberman, MD, of New York University (3-year, $225,000 grant)
- Innovative Research Award: Antiphospholipid antibodies in COVID-19, led by Jason Knight, MD, PhD, of the University of Michigan, Ann Arbor (2-year, $400,000 grant);
- Innovative Research Award: Effectiveness of telerheumatology for delivering high-quality rheumatology care during the COVID-19 crisis, led by Maria Danila, MD, MSc, MSPH, of University of Alabama at Birmingham (2-year, $400,000 grant)
- Norman B. Gaylis, MD, Clinical Research Award: Telehealth-delivered health care to improve care (THRIVE) in community-practice rheumatology, led by Swamy Venuturupalli, MD, of Beverly Hills, Calif.–based Attune Health (2-year, $400,000 grant)
Dr. Bridges said the foundation accepted submissions in basic science, translational science, clinical science, health services research, and patient- and practice-centered research.
“What differentiates these studies from our existing awards portfolio is they all explore the relationships between rheumatic and musculoskeletal diseases and SARS-CoV-2,” he said. “Ultimately, the outcomes of these projects will contribute to a more comprehensive knowledge base and advance avenues of patient care in the COVID-19 pandemic.”
Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., said he was pleased that a telehealth project was chosen as the award given in his name.
“From a COVID point of view, this has been extremely valuable in allowing us to continue to help out patients, connect with our patients, provide them treatment, even if it’s not hands on, at least guide them in how to deal with their chronic rheumatic illnesses,” he said.
This line of research can also help explore the feasibility of telemedicine in helping meet the needs of rural communities facing shortages of rheumatologists.
“Can telemedicine provide a source of rheumatologic access for people who really don’t have a live provider in close proximity?” he said. “I think that’s really why this particular award is very, very timely.”
“It’s so difficult for clinicians to get funding for their research, for their ideas and for the discoveries they were making on a day-to-day basis while they were practicing in a clinical community environment,” he said. “So for me it was really something that inspired me to really create this award.”
Five lines of research related to COVID-19 and people with rheumatic diseases will be explored with $1.65 million awarded recently by the Rheumatology Research Foundation.
Investigators will explore topics ranging from respiratory health to telemedicine with the awards, given by the foundation that is the largest private funding source for rheumatology research and training in the United States. The projects are an attempt to deepen the understanding about how people with rheumatic illnesses are affected by COVID-19.
“Our current understanding of why there are differences in severity of COVID-19 illness among rheumatology patients is limited,” Foundation President S. Louis Bridges, MD, PhD, said. “Additionally, there are many other gaps in our knowledge of the clinical aspects of SARS-CoV-2 infection in patients with rheumatic diseases, and how the pandemic has changed health care delivery. There is an urgent need to acquire new knowledge on COVID-19 in patients with [rheumatic and musculoskeletal diseases].”
These are the research projects funded:
- Scientist Development Award: Respiratory complications of coronavirus disease (COVID-19) in rheumatic diseases, led by Kristin D’Silva, MD, of Massachusetts General Hospital in Boston (3-year, $225,000 grant)
- Scientist Development Award: COVID-19 in patients with inflammatory arthritis: A prospective study on the effects of immunomodulatory therapy on susceptibility and clinical outcomes, by Rebecca Haberman, MD, of New York University (3-year, $225,000 grant)
- Innovative Research Award: Antiphospholipid antibodies in COVID-19, led by Jason Knight, MD, PhD, of the University of Michigan, Ann Arbor (2-year, $400,000 grant);
- Innovative Research Award: Effectiveness of telerheumatology for delivering high-quality rheumatology care during the COVID-19 crisis, led by Maria Danila, MD, MSc, MSPH, of University of Alabama at Birmingham (2-year, $400,000 grant)
- Norman B. Gaylis, MD, Clinical Research Award: Telehealth-delivered health care to improve care (THRIVE) in community-practice rheumatology, led by Swamy Venuturupalli, MD, of Beverly Hills, Calif.–based Attune Health (2-year, $400,000 grant)
Dr. Bridges said the foundation accepted submissions in basic science, translational science, clinical science, health services research, and patient- and practice-centered research.
“What differentiates these studies from our existing awards portfolio is they all explore the relationships between rheumatic and musculoskeletal diseases and SARS-CoV-2,” he said. “Ultimately, the outcomes of these projects will contribute to a more comprehensive knowledge base and advance avenues of patient care in the COVID-19 pandemic.”
Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., said he was pleased that a telehealth project was chosen as the award given in his name.
“From a COVID point of view, this has been extremely valuable in allowing us to continue to help out patients, connect with our patients, provide them treatment, even if it’s not hands on, at least guide them in how to deal with their chronic rheumatic illnesses,” he said.
This line of research can also help explore the feasibility of telemedicine in helping meet the needs of rural communities facing shortages of rheumatologists.
“Can telemedicine provide a source of rheumatologic access for people who really don’t have a live provider in close proximity?” he said. “I think that’s really why this particular award is very, very timely.”
“It’s so difficult for clinicians to get funding for their research, for their ideas and for the discoveries they were making on a day-to-day basis while they were practicing in a clinical community environment,” he said. “So for me it was really something that inspired me to really create this award.”
Five lines of research related to COVID-19 and people with rheumatic diseases will be explored with $1.65 million awarded recently by the Rheumatology Research Foundation.
Investigators will explore topics ranging from respiratory health to telemedicine with the awards, given by the foundation that is the largest private funding source for rheumatology research and training in the United States. The projects are an attempt to deepen the understanding about how people with rheumatic illnesses are affected by COVID-19.
“Our current understanding of why there are differences in severity of COVID-19 illness among rheumatology patients is limited,” Foundation President S. Louis Bridges, MD, PhD, said. “Additionally, there are many other gaps in our knowledge of the clinical aspects of SARS-CoV-2 infection in patients with rheumatic diseases, and how the pandemic has changed health care delivery. There is an urgent need to acquire new knowledge on COVID-19 in patients with [rheumatic and musculoskeletal diseases].”
These are the research projects funded:
- Scientist Development Award: Respiratory complications of coronavirus disease (COVID-19) in rheumatic diseases, led by Kristin D’Silva, MD, of Massachusetts General Hospital in Boston (3-year, $225,000 grant)
- Scientist Development Award: COVID-19 in patients with inflammatory arthritis: A prospective study on the effects of immunomodulatory therapy on susceptibility and clinical outcomes, by Rebecca Haberman, MD, of New York University (3-year, $225,000 grant)
- Innovative Research Award: Antiphospholipid antibodies in COVID-19, led by Jason Knight, MD, PhD, of the University of Michigan, Ann Arbor (2-year, $400,000 grant);
- Innovative Research Award: Effectiveness of telerheumatology for delivering high-quality rheumatology care during the COVID-19 crisis, led by Maria Danila, MD, MSc, MSPH, of University of Alabama at Birmingham (2-year, $400,000 grant)
- Norman B. Gaylis, MD, Clinical Research Award: Telehealth-delivered health care to improve care (THRIVE) in community-practice rheumatology, led by Swamy Venuturupalli, MD, of Beverly Hills, Calif.–based Attune Health (2-year, $400,000 grant)
Dr. Bridges said the foundation accepted submissions in basic science, translational science, clinical science, health services research, and patient- and practice-centered research.
“What differentiates these studies from our existing awards portfolio is they all explore the relationships between rheumatic and musculoskeletal diseases and SARS-CoV-2,” he said. “Ultimately, the outcomes of these projects will contribute to a more comprehensive knowledge base and advance avenues of patient care in the COVID-19 pandemic.”
Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., said he was pleased that a telehealth project was chosen as the award given in his name.
“From a COVID point of view, this has been extremely valuable in allowing us to continue to help out patients, connect with our patients, provide them treatment, even if it’s not hands on, at least guide them in how to deal with their chronic rheumatic illnesses,” he said.
This line of research can also help explore the feasibility of telemedicine in helping meet the needs of rural communities facing shortages of rheumatologists.
“Can telemedicine provide a source of rheumatologic access for people who really don’t have a live provider in close proximity?” he said. “I think that’s really why this particular award is very, very timely.”
“It’s so difficult for clinicians to get funding for their research, for their ideas and for the discoveries they were making on a day-to-day basis while they were practicing in a clinical community environment,” he said. “So for me it was really something that inspired me to really create this award.”
Teenagers get in the queue for COVID-19 vaccines
The vaccinations can’t come soon enough for parents like Stacy Hillenburg, a developmental therapist in Aurora, Ill., whose 9-year-old son takes immunosuppressants because he had a heart transplant when he was 7 weeks old. Although school-age children aren’t yet included in clinical trials, if her 12- and 13-year-old daughters could get vaccinated, along with both parents, then the family could relax some of the protocols they currently follow to prevent infection.
Whenever they are around other people, even masked and socially distanced, they come home and immediately shower and change their clothes. So far, no one in the family has been infected with COVID, but the anxiety is ever-present. “I can’t wait for it to come out,” Ms. Hillenburg said of a pediatric COVID vaccine. “It will ease my mind so much.”
She isn’t alone in that anticipation. In the fall, the American Academy of Pediatrics and other pediatric vaccine experts urged faster action on pediatric vaccine trials and worried that children would be left behind as adults gained protection from COVID. But recent developments have eased those concerns.
“Over the next couple of months, we will be doing trials in an age-deescalation manner,” with studies moving gradually to younger children, Anthony S. Fauci, MD, chief medical adviser on COVID-19 to the president, said in a coronavirus response team briefing on Jan. 29. “So that hopefully, as we get to the late spring and summer, we will have children being able to be vaccinated.”
Pfizer completed enrollment of 2,259 teens aged 12-15 years in late January and expects to move forward with a separate pediatric trial of children aged 5-11 years by this spring, Keanna Ghazvini, senior associate for global media relations at Pfizer, said in an interview.
Enrollment in Moderna’s TeenCove study of adolescents ages 12-17 years began slowly in late December, but the pace has since picked up, said company spokesperson Colleen Hussey. “We continue to bring clinical trial sites online, and we are on track to provide updated data around mid-year 2021.” A trial extension in children 11 years and younger is expected to begin later in 2021.
Johnson & Johnson and AstraZeneca said they expect to begin adolescent trials in early 2021, according to data shared by the Advisory Committee on Immunization Practices. An interim analysis of J&J’s Janssen COVID-19 vaccine trial data, released on Jan. 29, showed it was 72% effective in US participants aged 18 years or older. AstraZeneca’s U.S. trial in adults is ongoing.
Easing the burden
Vaccination could lessen children’s risk of severe disease as well as the social and emotional burdens of the pandemic, says James Campbell, MD, a pediatric infectious disease specialist at the University of Maryland’s Center for Vaccine Development in Baltimore, which was involved in the Moderna and early-phase Pfizer trials. He coauthored a September 2020 article in Clinical Infectious Diseases titled: “Warp Speed for COVID-19 vaccines: Why are children stuck in neutral?”
The adolescent trials are a vital step to ensure timely vaccine access for teens and younger children. “It is reasonable, when you have limited vaccine, that your rollout goes to the highest priority and then moves to lower and lower priorities. In adults, we’re just saying: ‘Wait your turn,’ ” he said of the current vaccination effort. “If we didn’t have the [vaccine trial] data in children, we’d be saying: ‘You don’t have a turn.’ ”
As the pandemic has worn on, the burden on children has grown. As of Tuesday, 269 children had died of COVID-19. That is well above the highest annual death toll recorded during a regular flu season – 188 flu deaths among children and adolescents under 18 in the 2019-2020 and 2017-2018 flu seasons.
Children are less likely to transmit COVID-19 in their household than adults, according to a meta-analysis of 54 studies published in JAMA Network Open. But that does not necessarily mean children are less infectious, the authors said, noting that unmeasured factors could have affected the spread of infection among adults.
Moreover, children and adolescents need protection from COVID infection – and from the potential for severe disease or lingering effects – and, given that there are 74 million children and teens in the United States, their vaccination is an important part of stopping the pandemic, said Grace Lee, MD, professor of pediatrics at Stanford (Calif.) University, and cochair of ACIP’s COVID-19 Vaccine Safety Technical Subgroup.
“In order to interrupt transmission, I don’t see how we’re going to do that without vaccinating children and adolescents,” she said.
Dr. Lee said her 16-year-old daughter misses the normal teenage social life and is excited about getting the vaccine when she is eligible. (Adolescents without high-risk conditions are in the lowest vaccination tier, according to ACIP recommendations.) “There is truly individual protection to be gained,” Dr. Lee said.
She noted that researchers continue to assess the immune responses to the adult vaccines – even looking at immune characteristics of the small percentage of people who aren’t protected from infection – and that information helps in the evaluation of the pediatric immune responses. As the trials expand to younger children and infants, dosing will be a major focus. “How many doses do they need they need to receive the same immunity? Safety considerations will be critically important,” she said.
Teen trials underway
Pfizer/BioNTech extended its adult trial to 16- and 17-year-olds in October, which enabled older teens to be included in its emergency-use authorization. They and younger teens, ages 12-15, receive the same dose as adults.
The ongoing trials with Pfizer and Moderna vaccines are immunobridging trials, designed to study safety and immunogenicity. Investigators will compare the teens’ immune response with the findings from the larger adult trials. When the trials expand to school-age children (6-12 years), protocols call for testing the safety and immunogenicity of a half-dose vaccine as well as the full dose.
Children ages 2-5 years and infants and toddlers will be enrolled in future trials, studying safety and immunogenicity of full, half, or even quarter dosages. The Pediatric Research Equity Act of 2003 requires licensed vaccines to be tested for safety and efficacy in children, unless they are not appropriate for a pediatric population.
Demand for the teen trials has been strong. At Cincinnati Children’s Hospital Medical Center, 259 teenagers joined the Pfizer/BioNTech trial, but some teenagers were turned away when the trial’s national enrollment closed in late January.
“Many of the children are having no side effects, and if they are, they’re having the same [effects] as the young adults – local redness or pain, fatigue, and headaches,” said Robert Frenck, MD, director of the Cincinnati Children’s Gamble Program for Clinical Studies.
Parents may share some of the vaccine hesitancy that has affected adult vaccination. But that is balanced by the hope that vaccines will end the pandemic and usher in a new normal. “If it looks like [vaccines] will increase the likelihood of children returning to school safely, that may be a motivating factor,” Dr. Frenck said.
Cody Meissner, MD, chief of the pediatric infectious disease service at Tufts Medical Center, Boston, was initially cautious about the extension of vaccination to adolescents. A member of the Vaccine and Related Biological Products Advisory Committee, which evaluates data and makes recommendations to the Food and Drug Administration, Dr. Meissner initially abstained in the vote on the Pfizer/BioNTech emergency-use authorization for people 16 and older.
He noted that, at the time the committee reviewed the Pfizer vaccine, the company had data available for just 134 teenagers, half of whom received a placebo. But the vaccination of 34 million adults has provided robust data about the vaccine’s safety, and the trial expansion into adolescents is important.
“I’m comfortable with the way these trials are going now,” he said. “This is the way I was hoping they would go.”
Ms. Hillenburg is on the parent advisory board of Voices for Vaccines, an organization of parents supporting vaccination that is affiliated with the Task Force for Global Health, an Atlanta-based independent public health organization. Dr. Campbell’s institution has received funds to conduct clinical trials from the National Institutes of Health and several companies, including Merck, GlaxoSmithKline, Sanofi, Pfizer, and Moderna. He has served pro bono on many safety and data monitoring committees. Dr. Frenck’s institution is receiving funds to conduct the Pfizer trial. In the past 5 years, he has also participated in clinical trials for GlaxoSmithKline, Merck, and Meissa vaccines. Dr. Lee and Dr. Meissner disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccinations can’t come soon enough for parents like Stacy Hillenburg, a developmental therapist in Aurora, Ill., whose 9-year-old son takes immunosuppressants because he had a heart transplant when he was 7 weeks old. Although school-age children aren’t yet included in clinical trials, if her 12- and 13-year-old daughters could get vaccinated, along with both parents, then the family could relax some of the protocols they currently follow to prevent infection.
Whenever they are around other people, even masked and socially distanced, they come home and immediately shower and change their clothes. So far, no one in the family has been infected with COVID, but the anxiety is ever-present. “I can’t wait for it to come out,” Ms. Hillenburg said of a pediatric COVID vaccine. “It will ease my mind so much.”
She isn’t alone in that anticipation. In the fall, the American Academy of Pediatrics and other pediatric vaccine experts urged faster action on pediatric vaccine trials and worried that children would be left behind as adults gained protection from COVID. But recent developments have eased those concerns.
“Over the next couple of months, we will be doing trials in an age-deescalation manner,” with studies moving gradually to younger children, Anthony S. Fauci, MD, chief medical adviser on COVID-19 to the president, said in a coronavirus response team briefing on Jan. 29. “So that hopefully, as we get to the late spring and summer, we will have children being able to be vaccinated.”
Pfizer completed enrollment of 2,259 teens aged 12-15 years in late January and expects to move forward with a separate pediatric trial of children aged 5-11 years by this spring, Keanna Ghazvini, senior associate for global media relations at Pfizer, said in an interview.
Enrollment in Moderna’s TeenCove study of adolescents ages 12-17 years began slowly in late December, but the pace has since picked up, said company spokesperson Colleen Hussey. “We continue to bring clinical trial sites online, and we are on track to provide updated data around mid-year 2021.” A trial extension in children 11 years and younger is expected to begin later in 2021.
Johnson & Johnson and AstraZeneca said they expect to begin adolescent trials in early 2021, according to data shared by the Advisory Committee on Immunization Practices. An interim analysis of J&J’s Janssen COVID-19 vaccine trial data, released on Jan. 29, showed it was 72% effective in US participants aged 18 years or older. AstraZeneca’s U.S. trial in adults is ongoing.
Easing the burden
Vaccination could lessen children’s risk of severe disease as well as the social and emotional burdens of the pandemic, says James Campbell, MD, a pediatric infectious disease specialist at the University of Maryland’s Center for Vaccine Development in Baltimore, which was involved in the Moderna and early-phase Pfizer trials. He coauthored a September 2020 article in Clinical Infectious Diseases titled: “Warp Speed for COVID-19 vaccines: Why are children stuck in neutral?”
The adolescent trials are a vital step to ensure timely vaccine access for teens and younger children. “It is reasonable, when you have limited vaccine, that your rollout goes to the highest priority and then moves to lower and lower priorities. In adults, we’re just saying: ‘Wait your turn,’ ” he said of the current vaccination effort. “If we didn’t have the [vaccine trial] data in children, we’d be saying: ‘You don’t have a turn.’ ”
As the pandemic has worn on, the burden on children has grown. As of Tuesday, 269 children had died of COVID-19. That is well above the highest annual death toll recorded during a regular flu season – 188 flu deaths among children and adolescents under 18 in the 2019-2020 and 2017-2018 flu seasons.
Children are less likely to transmit COVID-19 in their household than adults, according to a meta-analysis of 54 studies published in JAMA Network Open. But that does not necessarily mean children are less infectious, the authors said, noting that unmeasured factors could have affected the spread of infection among adults.
Moreover, children and adolescents need protection from COVID infection – and from the potential for severe disease or lingering effects – and, given that there are 74 million children and teens in the United States, their vaccination is an important part of stopping the pandemic, said Grace Lee, MD, professor of pediatrics at Stanford (Calif.) University, and cochair of ACIP’s COVID-19 Vaccine Safety Technical Subgroup.
“In order to interrupt transmission, I don’t see how we’re going to do that without vaccinating children and adolescents,” she said.
Dr. Lee said her 16-year-old daughter misses the normal teenage social life and is excited about getting the vaccine when she is eligible. (Adolescents without high-risk conditions are in the lowest vaccination tier, according to ACIP recommendations.) “There is truly individual protection to be gained,” Dr. Lee said.
She noted that researchers continue to assess the immune responses to the adult vaccines – even looking at immune characteristics of the small percentage of people who aren’t protected from infection – and that information helps in the evaluation of the pediatric immune responses. As the trials expand to younger children and infants, dosing will be a major focus. “How many doses do they need they need to receive the same immunity? Safety considerations will be critically important,” she said.
Teen trials underway
Pfizer/BioNTech extended its adult trial to 16- and 17-year-olds in October, which enabled older teens to be included in its emergency-use authorization. They and younger teens, ages 12-15, receive the same dose as adults.
The ongoing trials with Pfizer and Moderna vaccines are immunobridging trials, designed to study safety and immunogenicity. Investigators will compare the teens’ immune response with the findings from the larger adult trials. When the trials expand to school-age children (6-12 years), protocols call for testing the safety and immunogenicity of a half-dose vaccine as well as the full dose.
Children ages 2-5 years and infants and toddlers will be enrolled in future trials, studying safety and immunogenicity of full, half, or even quarter dosages. The Pediatric Research Equity Act of 2003 requires licensed vaccines to be tested for safety and efficacy in children, unless they are not appropriate for a pediatric population.
Demand for the teen trials has been strong. At Cincinnati Children’s Hospital Medical Center, 259 teenagers joined the Pfizer/BioNTech trial, but some teenagers were turned away when the trial’s national enrollment closed in late January.
“Many of the children are having no side effects, and if they are, they’re having the same [effects] as the young adults – local redness or pain, fatigue, and headaches,” said Robert Frenck, MD, director of the Cincinnati Children’s Gamble Program for Clinical Studies.
Parents may share some of the vaccine hesitancy that has affected adult vaccination. But that is balanced by the hope that vaccines will end the pandemic and usher in a new normal. “If it looks like [vaccines] will increase the likelihood of children returning to school safely, that may be a motivating factor,” Dr. Frenck said.
Cody Meissner, MD, chief of the pediatric infectious disease service at Tufts Medical Center, Boston, was initially cautious about the extension of vaccination to adolescents. A member of the Vaccine and Related Biological Products Advisory Committee, which evaluates data and makes recommendations to the Food and Drug Administration, Dr. Meissner initially abstained in the vote on the Pfizer/BioNTech emergency-use authorization for people 16 and older.
He noted that, at the time the committee reviewed the Pfizer vaccine, the company had data available for just 134 teenagers, half of whom received a placebo. But the vaccination of 34 million adults has provided robust data about the vaccine’s safety, and the trial expansion into adolescents is important.
“I’m comfortable with the way these trials are going now,” he said. “This is the way I was hoping they would go.”
Ms. Hillenburg is on the parent advisory board of Voices for Vaccines, an organization of parents supporting vaccination that is affiliated with the Task Force for Global Health, an Atlanta-based independent public health organization. Dr. Campbell’s institution has received funds to conduct clinical trials from the National Institutes of Health and several companies, including Merck, GlaxoSmithKline, Sanofi, Pfizer, and Moderna. He has served pro bono on many safety and data monitoring committees. Dr. Frenck’s institution is receiving funds to conduct the Pfizer trial. In the past 5 years, he has also participated in clinical trials for GlaxoSmithKline, Merck, and Meissa vaccines. Dr. Lee and Dr. Meissner disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccinations can’t come soon enough for parents like Stacy Hillenburg, a developmental therapist in Aurora, Ill., whose 9-year-old son takes immunosuppressants because he had a heart transplant when he was 7 weeks old. Although school-age children aren’t yet included in clinical trials, if her 12- and 13-year-old daughters could get vaccinated, along with both parents, then the family could relax some of the protocols they currently follow to prevent infection.
Whenever they are around other people, even masked and socially distanced, they come home and immediately shower and change their clothes. So far, no one in the family has been infected with COVID, but the anxiety is ever-present. “I can’t wait for it to come out,” Ms. Hillenburg said of a pediatric COVID vaccine. “It will ease my mind so much.”
She isn’t alone in that anticipation. In the fall, the American Academy of Pediatrics and other pediatric vaccine experts urged faster action on pediatric vaccine trials and worried that children would be left behind as adults gained protection from COVID. But recent developments have eased those concerns.
“Over the next couple of months, we will be doing trials in an age-deescalation manner,” with studies moving gradually to younger children, Anthony S. Fauci, MD, chief medical adviser on COVID-19 to the president, said in a coronavirus response team briefing on Jan. 29. “So that hopefully, as we get to the late spring and summer, we will have children being able to be vaccinated.”
Pfizer completed enrollment of 2,259 teens aged 12-15 years in late January and expects to move forward with a separate pediatric trial of children aged 5-11 years by this spring, Keanna Ghazvini, senior associate for global media relations at Pfizer, said in an interview.
Enrollment in Moderna’s TeenCove study of adolescents ages 12-17 years began slowly in late December, but the pace has since picked up, said company spokesperson Colleen Hussey. “We continue to bring clinical trial sites online, and we are on track to provide updated data around mid-year 2021.” A trial extension in children 11 years and younger is expected to begin later in 2021.
Johnson & Johnson and AstraZeneca said they expect to begin adolescent trials in early 2021, according to data shared by the Advisory Committee on Immunization Practices. An interim analysis of J&J’s Janssen COVID-19 vaccine trial data, released on Jan. 29, showed it was 72% effective in US participants aged 18 years or older. AstraZeneca’s U.S. trial in adults is ongoing.
Easing the burden
Vaccination could lessen children’s risk of severe disease as well as the social and emotional burdens of the pandemic, says James Campbell, MD, a pediatric infectious disease specialist at the University of Maryland’s Center for Vaccine Development in Baltimore, which was involved in the Moderna and early-phase Pfizer trials. He coauthored a September 2020 article in Clinical Infectious Diseases titled: “Warp Speed for COVID-19 vaccines: Why are children stuck in neutral?”
The adolescent trials are a vital step to ensure timely vaccine access for teens and younger children. “It is reasonable, when you have limited vaccine, that your rollout goes to the highest priority and then moves to lower and lower priorities. In adults, we’re just saying: ‘Wait your turn,’ ” he said of the current vaccination effort. “If we didn’t have the [vaccine trial] data in children, we’d be saying: ‘You don’t have a turn.’ ”
As the pandemic has worn on, the burden on children has grown. As of Tuesday, 269 children had died of COVID-19. That is well above the highest annual death toll recorded during a regular flu season – 188 flu deaths among children and adolescents under 18 in the 2019-2020 and 2017-2018 flu seasons.
Children are less likely to transmit COVID-19 in their household than adults, according to a meta-analysis of 54 studies published in JAMA Network Open. But that does not necessarily mean children are less infectious, the authors said, noting that unmeasured factors could have affected the spread of infection among adults.
Moreover, children and adolescents need protection from COVID infection – and from the potential for severe disease or lingering effects – and, given that there are 74 million children and teens in the United States, their vaccination is an important part of stopping the pandemic, said Grace Lee, MD, professor of pediatrics at Stanford (Calif.) University, and cochair of ACIP’s COVID-19 Vaccine Safety Technical Subgroup.
“In order to interrupt transmission, I don’t see how we’re going to do that without vaccinating children and adolescents,” she said.
Dr. Lee said her 16-year-old daughter misses the normal teenage social life and is excited about getting the vaccine when she is eligible. (Adolescents without high-risk conditions are in the lowest vaccination tier, according to ACIP recommendations.) “There is truly individual protection to be gained,” Dr. Lee said.
She noted that researchers continue to assess the immune responses to the adult vaccines – even looking at immune characteristics of the small percentage of people who aren’t protected from infection – and that information helps in the evaluation of the pediatric immune responses. As the trials expand to younger children and infants, dosing will be a major focus. “How many doses do they need they need to receive the same immunity? Safety considerations will be critically important,” she said.
Teen trials underway
Pfizer/BioNTech extended its adult trial to 16- and 17-year-olds in October, which enabled older teens to be included in its emergency-use authorization. They and younger teens, ages 12-15, receive the same dose as adults.
The ongoing trials with Pfizer and Moderna vaccines are immunobridging trials, designed to study safety and immunogenicity. Investigators will compare the teens’ immune response with the findings from the larger adult trials. When the trials expand to school-age children (6-12 years), protocols call for testing the safety and immunogenicity of a half-dose vaccine as well as the full dose.
Children ages 2-5 years and infants and toddlers will be enrolled in future trials, studying safety and immunogenicity of full, half, or even quarter dosages. The Pediatric Research Equity Act of 2003 requires licensed vaccines to be tested for safety and efficacy in children, unless they are not appropriate for a pediatric population.
Demand for the teen trials has been strong. At Cincinnati Children’s Hospital Medical Center, 259 teenagers joined the Pfizer/BioNTech trial, but some teenagers were turned away when the trial’s national enrollment closed in late January.
“Many of the children are having no side effects, and if they are, they’re having the same [effects] as the young adults – local redness or pain, fatigue, and headaches,” said Robert Frenck, MD, director of the Cincinnati Children’s Gamble Program for Clinical Studies.
Parents may share some of the vaccine hesitancy that has affected adult vaccination. But that is balanced by the hope that vaccines will end the pandemic and usher in a new normal. “If it looks like [vaccines] will increase the likelihood of children returning to school safely, that may be a motivating factor,” Dr. Frenck said.
Cody Meissner, MD, chief of the pediatric infectious disease service at Tufts Medical Center, Boston, was initially cautious about the extension of vaccination to adolescents. A member of the Vaccine and Related Biological Products Advisory Committee, which evaluates data and makes recommendations to the Food and Drug Administration, Dr. Meissner initially abstained in the vote on the Pfizer/BioNTech emergency-use authorization for people 16 and older.
He noted that, at the time the committee reviewed the Pfizer vaccine, the company had data available for just 134 teenagers, half of whom received a placebo. But the vaccination of 34 million adults has provided robust data about the vaccine’s safety, and the trial expansion into adolescents is important.
“I’m comfortable with the way these trials are going now,” he said. “This is the way I was hoping they would go.”
Ms. Hillenburg is on the parent advisory board of Voices for Vaccines, an organization of parents supporting vaccination that is affiliated with the Task Force for Global Health, an Atlanta-based independent public health organization. Dr. Campbell’s institution has received funds to conduct clinical trials from the National Institutes of Health and several companies, including Merck, GlaxoSmithKline, Sanofi, Pfizer, and Moderna. He has served pro bono on many safety and data monitoring committees. Dr. Frenck’s institution is receiving funds to conduct the Pfizer trial. In the past 5 years, he has also participated in clinical trials for GlaxoSmithKline, Merck, and Meissa vaccines. Dr. Lee and Dr. Meissner disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women increasingly turn to CBD, with or without doc’s blessing
When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.
A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.
Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.
Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.
Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.
Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”
Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.
Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.
Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.
In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
The gray zone
There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.
“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”
One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.
This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”
Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”
The ‘entourage effect’
Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.
In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.
Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
It’s the data
Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”
Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”
Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.
Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”
That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”
A version of this article first appeared on Medscape.com.
When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.
A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.
Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.
Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.
Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.
Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”
Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.
Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.
Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.
In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
The gray zone
There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.
“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”
One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.
This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”
Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”
The ‘entourage effect’
Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.
In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.
Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
It’s the data
Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”
Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”
Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.
Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”
That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”
A version of this article first appeared on Medscape.com.
When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.
A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.
Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.
Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.
Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.
Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”
Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.
Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.
Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.
In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
The gray zone
There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.
“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”
One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.
This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”
Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”
The ‘entourage effect’
Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.
In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.
Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
It’s the data
Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”
Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”
Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.
Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”
That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”
A version of this article first appeared on Medscape.com.
As demand for mental health care spikes, budget ax set to strike
When the pandemic hit, health officials in Montana’s Beaverhead County had barely begun to fill a hole left by the 2017 closure of the local public assistance office, mental health clinic, chemical dependency center and job placement office after the state’s last budget shortfall.
Now, those health officials worry more cuts are coming, even as they brace for a spike in demand for substance abuse and mental health services. That would be no small challenge in a poor farming and ranching region where stigma often prevents people from admitting they need help, said Katherine Buckley-Patton, who chairs the county’s Mental Health Local Advisory Council.
“I find it very challenging to find the words that will not make one of my hard-nosed cowboys turn around and walk away,” Ms. Buckley-Patton said.
States across the U.S. are still stinging after businesses closed and millions of people lost jobs because of COVID-related shutdowns and restrictions. Meanwhile, the pandemic has led to a dramatic increase in the number of people who say their mental health has suffered, rising from one in three people in March to more than half of people polled by KFF in July. (KHN is an editorially independent program of KFF.)
The full extent of the mental health crisis and the demand for behavioral health services may not be known until after the pandemic is over, mental health experts said. That could add costs that budget writers haven’t anticipated.
“It usually takes a while before people feel comfortable seeking care from a specialty behavioral health organization,” said Chuck Ingoglia, president and CEO of the nonprofit National Council for Behavioral Health in Washington, D.C. “We are not likely to see the results of that either in terms of people seeking care – or suicide rates going up – until we’re on the other side of the pandemic.”
Last year, states slashed agency budgets, froze pay, furloughed workers, borrowed money, and tapped into rainy-day funds to make ends meet. Health programs, often among the most expensive part of a state’s budget, were targeted for cuts in several states even as health officials led efforts to stem the spread of the coronavirus.
This year, the outlook doesn’t seem quite so bleak, partly because of relief packages passed by Congress last spring and in December that buoyed state economies. Another major advantage was that income increased or held steady for people with well-paying jobs and investment income, which boosted states’ tax revenues even as millions of lower-income workers were laid off.
“It has turned out to be not as bad as it might have been in terms of state budgets,” said Mike Leachman, vice president for state fiscal policy for the nonpartisan Center on Budget and Policy Priorities.
But many states still face cash shortfalls that will be made worse if additional federal aid doesn’t come, Mr. Leachman said. President Joe Biden has pledged to push through Congress a $1.9 billion relief package that includes aid to states, while congressional Republicans are proposing a package worth about a third of that amount. States are banking on federal help.
New York Gov. Andrew Cuomo, a Democrat, predicted his state would have to plug a $15 billion deficit with spending cuts and tax increases if a fresh round of aid doesn’t materialize. Some states, such as New Jersey, borrowed to make their budgets whole, and they’re going to have to start paying that money back. Tourism states such as Hawaii and energy-producing states such as Alaska and Wyoming continue to face grim economic outlooks with oil, gas, and coal prices down and tourists cutting back on travel, Mr. Leachman said.
Even states with a relatively rosy economic outlook are being cautious. In Colorado, for example, Democratic Gov. Jared Polis proposed a budget that restores the cuts made last year to Medicaid and substance abuse programs. But health providers are doubtful the legislature will approve any significant spending increases in this economy.
“Everybody right now is just trying to protect and make sure we don’t have additional cuts,” said Doyle Forrestal, CEO of the Colorado Behavioral Healthcare Council.
That’s also what Ms. Buckley-Patton wants for Montana’s Beaverhead County, where most of the 9,400 residents live in poverty or earn low incomes.
She led the county’s effort to recover from the loss in 2017 of a wide range of behavioral health services, along with offices to help poor people receive Medicaid health services, plus cash and food assistance.
Through persuasive grant writing and donations coaxed from elected officials, Ms. Buckley-Patton and her team secured office space, equipment, and a part-time employee for a resource center that’s open once a week in the county in the southwestern corner of the state, she said. They also convinced the state health department to send two people every other week on a 120-mile round trip from the Butte office to help county residents with their Medicaid and public assistance applications.
But now Ms. Buckley-Patton worries even those modest gains will be threatened in this year’s budget. Montana is one of the few states with a budget on a 2-year cycle, so this is the first time lawmakers have had to craft a spending plan since the pandemic began.
Revenue forecasts predict healthy tax collections over the next 2 years.
In January, at the start of the legislative session, the panel in charge of building the state health department’s budget proposed starting with nearly $1 billion in cuts. The panel’s chairperson, Republican Rep. Matt Regier, pledged to add back programs and services on their merits during the months-long budget process.
It’s a strategy Ms. Buckley-Patton worries will lead to a net loss of funding for Beaverhead County, which covers more land than Connecticut.
“I have grave concerns about this legislative session,” she said. “We’re not digging out of the hole; we’re only going deeper.”
Republicans, who are in control of the Montana House, Senate, and governor’s office for the first time in 16 years, are considering reducing the income tax level for the state’s top earners. Such a measure that could affect state revenue in an uncertain economy has some observers concerned, particularly when an increased need for health services is expected.
“Are legislators committed to building back up that budget in a way that works for communities and for health providers, or are we going to see tax cuts that reduce revenue that put us yet again in another really tight budget?” asked Heather O’Loughlin, codirector of the Montana Budget and Policy Center.
Mary Windecker, executive director of the Behavioral Health Alliance of Montana, said that health providers across the state are still clawing back from more than $100 million in budget cuts in 2017, and that she worries more cuts are on the horizon.
But one bright spot, she said, is a proposal by new Gov. Greg Gianforte to create a fund that would put $23 million a year toward community substance abuse prevention and treatment programs. It would be partially funded by tax revenue the state will receive from recreational marijuana, which voters approved in November, with sales to begin next year.
Ms. Windecker cautioned, though, that mental health and substance use are linked, and the governor and lawmakers should plan with that in mind.
“In the public’s mind, there’s drug addicts and there’s the mentally ill,” she said. “Quite often, the same people who have a substance use disorder are using it to treat a mental health issue that is underlying that substance use. So, you can never split the two out.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
When the pandemic hit, health officials in Montana’s Beaverhead County had barely begun to fill a hole left by the 2017 closure of the local public assistance office, mental health clinic, chemical dependency center and job placement office after the state’s last budget shortfall.
Now, those health officials worry more cuts are coming, even as they brace for a spike in demand for substance abuse and mental health services. That would be no small challenge in a poor farming and ranching region where stigma often prevents people from admitting they need help, said Katherine Buckley-Patton, who chairs the county’s Mental Health Local Advisory Council.
“I find it very challenging to find the words that will not make one of my hard-nosed cowboys turn around and walk away,” Ms. Buckley-Patton said.
States across the U.S. are still stinging after businesses closed and millions of people lost jobs because of COVID-related shutdowns and restrictions. Meanwhile, the pandemic has led to a dramatic increase in the number of people who say their mental health has suffered, rising from one in three people in March to more than half of people polled by KFF in July. (KHN is an editorially independent program of KFF.)
The full extent of the mental health crisis and the demand for behavioral health services may not be known until after the pandemic is over, mental health experts said. That could add costs that budget writers haven’t anticipated.
“It usually takes a while before people feel comfortable seeking care from a specialty behavioral health organization,” said Chuck Ingoglia, president and CEO of the nonprofit National Council for Behavioral Health in Washington, D.C. “We are not likely to see the results of that either in terms of people seeking care – or suicide rates going up – until we’re on the other side of the pandemic.”
Last year, states slashed agency budgets, froze pay, furloughed workers, borrowed money, and tapped into rainy-day funds to make ends meet. Health programs, often among the most expensive part of a state’s budget, were targeted for cuts in several states even as health officials led efforts to stem the spread of the coronavirus.
This year, the outlook doesn’t seem quite so bleak, partly because of relief packages passed by Congress last spring and in December that buoyed state economies. Another major advantage was that income increased or held steady for people with well-paying jobs and investment income, which boosted states’ tax revenues even as millions of lower-income workers were laid off.
“It has turned out to be not as bad as it might have been in terms of state budgets,” said Mike Leachman, vice president for state fiscal policy for the nonpartisan Center on Budget and Policy Priorities.
But many states still face cash shortfalls that will be made worse if additional federal aid doesn’t come, Mr. Leachman said. President Joe Biden has pledged to push through Congress a $1.9 billion relief package that includes aid to states, while congressional Republicans are proposing a package worth about a third of that amount. States are banking on federal help.
New York Gov. Andrew Cuomo, a Democrat, predicted his state would have to plug a $15 billion deficit with spending cuts and tax increases if a fresh round of aid doesn’t materialize. Some states, such as New Jersey, borrowed to make their budgets whole, and they’re going to have to start paying that money back. Tourism states such as Hawaii and energy-producing states such as Alaska and Wyoming continue to face grim economic outlooks with oil, gas, and coal prices down and tourists cutting back on travel, Mr. Leachman said.
Even states with a relatively rosy economic outlook are being cautious. In Colorado, for example, Democratic Gov. Jared Polis proposed a budget that restores the cuts made last year to Medicaid and substance abuse programs. But health providers are doubtful the legislature will approve any significant spending increases in this economy.
“Everybody right now is just trying to protect and make sure we don’t have additional cuts,” said Doyle Forrestal, CEO of the Colorado Behavioral Healthcare Council.
That’s also what Ms. Buckley-Patton wants for Montana’s Beaverhead County, where most of the 9,400 residents live in poverty or earn low incomes.
She led the county’s effort to recover from the loss in 2017 of a wide range of behavioral health services, along with offices to help poor people receive Medicaid health services, plus cash and food assistance.
Through persuasive grant writing and donations coaxed from elected officials, Ms. Buckley-Patton and her team secured office space, equipment, and a part-time employee for a resource center that’s open once a week in the county in the southwestern corner of the state, she said. They also convinced the state health department to send two people every other week on a 120-mile round trip from the Butte office to help county residents with their Medicaid and public assistance applications.
But now Ms. Buckley-Patton worries even those modest gains will be threatened in this year’s budget. Montana is one of the few states with a budget on a 2-year cycle, so this is the first time lawmakers have had to craft a spending plan since the pandemic began.
Revenue forecasts predict healthy tax collections over the next 2 years.
In January, at the start of the legislative session, the panel in charge of building the state health department’s budget proposed starting with nearly $1 billion in cuts. The panel’s chairperson, Republican Rep. Matt Regier, pledged to add back programs and services on their merits during the months-long budget process.
It’s a strategy Ms. Buckley-Patton worries will lead to a net loss of funding for Beaverhead County, which covers more land than Connecticut.
“I have grave concerns about this legislative session,” she said. “We’re not digging out of the hole; we’re only going deeper.”
Republicans, who are in control of the Montana House, Senate, and governor’s office for the first time in 16 years, are considering reducing the income tax level for the state’s top earners. Such a measure that could affect state revenue in an uncertain economy has some observers concerned, particularly when an increased need for health services is expected.
“Are legislators committed to building back up that budget in a way that works for communities and for health providers, or are we going to see tax cuts that reduce revenue that put us yet again in another really tight budget?” asked Heather O’Loughlin, codirector of the Montana Budget and Policy Center.
Mary Windecker, executive director of the Behavioral Health Alliance of Montana, said that health providers across the state are still clawing back from more than $100 million in budget cuts in 2017, and that she worries more cuts are on the horizon.
But one bright spot, she said, is a proposal by new Gov. Greg Gianforte to create a fund that would put $23 million a year toward community substance abuse prevention and treatment programs. It would be partially funded by tax revenue the state will receive from recreational marijuana, which voters approved in November, with sales to begin next year.
Ms. Windecker cautioned, though, that mental health and substance use are linked, and the governor and lawmakers should plan with that in mind.
“In the public’s mind, there’s drug addicts and there’s the mentally ill,” she said. “Quite often, the same people who have a substance use disorder are using it to treat a mental health issue that is underlying that substance use. So, you can never split the two out.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
When the pandemic hit, health officials in Montana’s Beaverhead County had barely begun to fill a hole left by the 2017 closure of the local public assistance office, mental health clinic, chemical dependency center and job placement office after the state’s last budget shortfall.
Now, those health officials worry more cuts are coming, even as they brace for a spike in demand for substance abuse and mental health services. That would be no small challenge in a poor farming and ranching region where stigma often prevents people from admitting they need help, said Katherine Buckley-Patton, who chairs the county’s Mental Health Local Advisory Council.
“I find it very challenging to find the words that will not make one of my hard-nosed cowboys turn around and walk away,” Ms. Buckley-Patton said.
States across the U.S. are still stinging after businesses closed and millions of people lost jobs because of COVID-related shutdowns and restrictions. Meanwhile, the pandemic has led to a dramatic increase in the number of people who say their mental health has suffered, rising from one in three people in March to more than half of people polled by KFF in July. (KHN is an editorially independent program of KFF.)
The full extent of the mental health crisis and the demand for behavioral health services may not be known until after the pandemic is over, mental health experts said. That could add costs that budget writers haven’t anticipated.
“It usually takes a while before people feel comfortable seeking care from a specialty behavioral health organization,” said Chuck Ingoglia, president and CEO of the nonprofit National Council for Behavioral Health in Washington, D.C. “We are not likely to see the results of that either in terms of people seeking care – or suicide rates going up – until we’re on the other side of the pandemic.”
Last year, states slashed agency budgets, froze pay, furloughed workers, borrowed money, and tapped into rainy-day funds to make ends meet. Health programs, often among the most expensive part of a state’s budget, were targeted for cuts in several states even as health officials led efforts to stem the spread of the coronavirus.
This year, the outlook doesn’t seem quite so bleak, partly because of relief packages passed by Congress last spring and in December that buoyed state economies. Another major advantage was that income increased or held steady for people with well-paying jobs and investment income, which boosted states’ tax revenues even as millions of lower-income workers were laid off.
“It has turned out to be not as bad as it might have been in terms of state budgets,” said Mike Leachman, vice president for state fiscal policy for the nonpartisan Center on Budget and Policy Priorities.
But many states still face cash shortfalls that will be made worse if additional federal aid doesn’t come, Mr. Leachman said. President Joe Biden has pledged to push through Congress a $1.9 billion relief package that includes aid to states, while congressional Republicans are proposing a package worth about a third of that amount. States are banking on federal help.
New York Gov. Andrew Cuomo, a Democrat, predicted his state would have to plug a $15 billion deficit with spending cuts and tax increases if a fresh round of aid doesn’t materialize. Some states, such as New Jersey, borrowed to make their budgets whole, and they’re going to have to start paying that money back. Tourism states such as Hawaii and energy-producing states such as Alaska and Wyoming continue to face grim economic outlooks with oil, gas, and coal prices down and tourists cutting back on travel, Mr. Leachman said.
Even states with a relatively rosy economic outlook are being cautious. In Colorado, for example, Democratic Gov. Jared Polis proposed a budget that restores the cuts made last year to Medicaid and substance abuse programs. But health providers are doubtful the legislature will approve any significant spending increases in this economy.
“Everybody right now is just trying to protect and make sure we don’t have additional cuts,” said Doyle Forrestal, CEO of the Colorado Behavioral Healthcare Council.
That’s also what Ms. Buckley-Patton wants for Montana’s Beaverhead County, where most of the 9,400 residents live in poverty or earn low incomes.
She led the county’s effort to recover from the loss in 2017 of a wide range of behavioral health services, along with offices to help poor people receive Medicaid health services, plus cash and food assistance.
Through persuasive grant writing and donations coaxed from elected officials, Ms. Buckley-Patton and her team secured office space, equipment, and a part-time employee for a resource center that’s open once a week in the county in the southwestern corner of the state, she said. They also convinced the state health department to send two people every other week on a 120-mile round trip from the Butte office to help county residents with their Medicaid and public assistance applications.
But now Ms. Buckley-Patton worries even those modest gains will be threatened in this year’s budget. Montana is one of the few states with a budget on a 2-year cycle, so this is the first time lawmakers have had to craft a spending plan since the pandemic began.
Revenue forecasts predict healthy tax collections over the next 2 years.
In January, at the start of the legislative session, the panel in charge of building the state health department’s budget proposed starting with nearly $1 billion in cuts. The panel’s chairperson, Republican Rep. Matt Regier, pledged to add back programs and services on their merits during the months-long budget process.
It’s a strategy Ms. Buckley-Patton worries will lead to a net loss of funding for Beaverhead County, which covers more land than Connecticut.
“I have grave concerns about this legislative session,” she said. “We’re not digging out of the hole; we’re only going deeper.”
Republicans, who are in control of the Montana House, Senate, and governor’s office for the first time in 16 years, are considering reducing the income tax level for the state’s top earners. Such a measure that could affect state revenue in an uncertain economy has some observers concerned, particularly when an increased need for health services is expected.
“Are legislators committed to building back up that budget in a way that works for communities and for health providers, or are we going to see tax cuts that reduce revenue that put us yet again in another really tight budget?” asked Heather O’Loughlin, codirector of the Montana Budget and Policy Center.
Mary Windecker, executive director of the Behavioral Health Alliance of Montana, said that health providers across the state are still clawing back from more than $100 million in budget cuts in 2017, and that she worries more cuts are on the horizon.
But one bright spot, she said, is a proposal by new Gov. Greg Gianforte to create a fund that would put $23 million a year toward community substance abuse prevention and treatment programs. It would be partially funded by tax revenue the state will receive from recreational marijuana, which voters approved in November, with sales to begin next year.
Ms. Windecker cautioned, though, that mental health and substance use are linked, and the governor and lawmakers should plan with that in mind.
“In the public’s mind, there’s drug addicts and there’s the mentally ill,” she said. “Quite often, the same people who have a substance use disorder are using it to treat a mental health issue that is underlying that substance use. So, you can never split the two out.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
COVID-19 in children: New cases down for third straight week
New COVID-19 cases in children dropped for the third consecutive week, even as children continue to make up a larger share of all cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New child cases totaled almost 118,000 for the week of Jan. 29-Feb. 4, continuing the decline that began right after the United States topped 200,000 cases for the only time Jan. 8-14, the AAP and the CHA said in their weekly COVID-19 report.
For the latest week, however, children represented 16.0% of all new COVID-19 cases, continuing a 5-week increase that began in early December 2020, after the proportion had dropped to 12.6%, based on data collected from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. During the week of Sept. 11-17, children made up 16.9% of all cases, the highest level seen during the pandemic.
The 2.93 million cases that have been reported in children make up 12.9% of all cases since the pandemic began, and the overall rate of pediatric coronavirus infection is 3,899 cases per 100,000 children in the population. Taking a step down from the national level, 30 states are above that rate and 18 are below it, along with D.C., New York City, Puerto Rico, and Guam (New York and Texas are excluded), the AAP and CHA reported.
There were 12 new COVID-19–related child deaths in the 43 states, along with New York City and Guam, that are reporting such data, bringing the total to 227. Nationally, 0.06% of all deaths have occurred in children, with rates ranging from 0.00% (11 states) to 0.26% (Nebraska) in the 45 jurisdictions, the AAP/CHA report shows.
Child hospitalizations rose to 1.9% of all hospitalizations after holding at 1.8% since mid-November in 25 reporting jurisdictions (24 states and New York City), but the hospitalization rate among children with COVID held at 0.8%, where it has been for the last 4 weeks. Hospitalization rates as high as 3.8% were recorded early in the pandemic, the AAP and CHA noted.
New COVID-19 cases in children dropped for the third consecutive week, even as children continue to make up a larger share of all cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New child cases totaled almost 118,000 for the week of Jan. 29-Feb. 4, continuing the decline that began right after the United States topped 200,000 cases for the only time Jan. 8-14, the AAP and the CHA said in their weekly COVID-19 report.
For the latest week, however, children represented 16.0% of all new COVID-19 cases, continuing a 5-week increase that began in early December 2020, after the proportion had dropped to 12.6%, based on data collected from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. During the week of Sept. 11-17, children made up 16.9% of all cases, the highest level seen during the pandemic.
The 2.93 million cases that have been reported in children make up 12.9% of all cases since the pandemic began, and the overall rate of pediatric coronavirus infection is 3,899 cases per 100,000 children in the population. Taking a step down from the national level, 30 states are above that rate and 18 are below it, along with D.C., New York City, Puerto Rico, and Guam (New York and Texas are excluded), the AAP and CHA reported.
There were 12 new COVID-19–related child deaths in the 43 states, along with New York City and Guam, that are reporting such data, bringing the total to 227. Nationally, 0.06% of all deaths have occurred in children, with rates ranging from 0.00% (11 states) to 0.26% (Nebraska) in the 45 jurisdictions, the AAP/CHA report shows.
Child hospitalizations rose to 1.9% of all hospitalizations after holding at 1.8% since mid-November in 25 reporting jurisdictions (24 states and New York City), but the hospitalization rate among children with COVID held at 0.8%, where it has been for the last 4 weeks. Hospitalization rates as high as 3.8% were recorded early in the pandemic, the AAP and CHA noted.
New COVID-19 cases in children dropped for the third consecutive week, even as children continue to make up a larger share of all cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New child cases totaled almost 118,000 for the week of Jan. 29-Feb. 4, continuing the decline that began right after the United States topped 200,000 cases for the only time Jan. 8-14, the AAP and the CHA said in their weekly COVID-19 report.
For the latest week, however, children represented 16.0% of all new COVID-19 cases, continuing a 5-week increase that began in early December 2020, after the proportion had dropped to 12.6%, based on data collected from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. During the week of Sept. 11-17, children made up 16.9% of all cases, the highest level seen during the pandemic.
The 2.93 million cases that have been reported in children make up 12.9% of all cases since the pandemic began, and the overall rate of pediatric coronavirus infection is 3,899 cases per 100,000 children in the population. Taking a step down from the national level, 30 states are above that rate and 18 are below it, along with D.C., New York City, Puerto Rico, and Guam (New York and Texas are excluded), the AAP and CHA reported.
There were 12 new COVID-19–related child deaths in the 43 states, along with New York City and Guam, that are reporting such data, bringing the total to 227. Nationally, 0.06% of all deaths have occurred in children, with rates ranging from 0.00% (11 states) to 0.26% (Nebraska) in the 45 jurisdictions, the AAP/CHA report shows.
Child hospitalizations rose to 1.9% of all hospitalizations after holding at 1.8% since mid-November in 25 reporting jurisdictions (24 states and New York City), but the hospitalization rate among children with COVID held at 0.8%, where it has been for the last 4 weeks. Hospitalization rates as high as 3.8% were recorded early in the pandemic, the AAP and CHA noted.
U.K. COVID-19 variant doubling every 10 days in the U.S.: Study
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
Children in ICU for COVID-19 likely to be older, Black, and asthmatic
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.