Pediatrics

Among pediatric patients with multiple sclerosis (MS), some specific clinical characteristics, as well as treatment with disease-modifying therapies (DMTs), are linked to less future disability.

An estimated 3%-10% of MS patients are diagnosed during childhood. These patients experience a higher relapse rate and have higher magnetic resonance imaging (MRI) activity than do adult-onset patients. They have a slower rate of progression, but they reach irreversible disability milestones at an early age, with more than 50% having secondary progressive disease by age 30.

Studies in adults suggest that use of high-efficacy DMTs is most effective when initiated during the early active phase of MS, but little is known about children. “Early recognition of predictors of faster disability in children is crucial for clinicians to make the treatment decisions at the earliest possible time,” Sifat Sharmin, PhD, said during her presentation of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Sharmin is a statistician and research fellow at the University of Melbourne.
 

‘Reassuring’ data

“I think the most important observation that was made here is the protective factor of use of high efficacy disease modifying therapies,” said Bruce Cree, MD, PhD, who was asked to comment on the study.

That result wasn’t unexpected, but it should provide reassurance. “For parents of children who are hesitant about use of high efficacy therapies, this study provides supporting evidence for use of these high efficacy therapies early on, to try and prevent irreversible disability from occurring,” said Dr. Cree, professor of clinical neurology and the George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California at San Francisco UCSF Weill Institute for Neurosciences.

The study provides real-world data to back up findings from a phase 3 clinical trial that showed fewer relapses and fewer new lesions in pediatric patients with MS who were taking fingolimod versus interferon beta-1a.

“Given a large randomized, controlled trial, and now with this additional real-world data set showing the same thing, the only conclusion to reach is that if you’ve got a kid with MS, they should be treated with fingolimod,” said Dr. Cree. He noted that other DMTs such as natalizumab may also benefit pediatric patients, but fingolimod is the only drug that has been studied in randomized, controlled trials in children.

Real-world data

The researchers analyzed data from 672 patients drawn from the international MSBase Neuroimmunology Registry, who had undergone neurological assessment within 1 year of symptom onset and had at least two annual visits where the Expanded Disability Status Scale (EDSS) was recorded. They sought to identify predictors of Multiple Sclerosis Severity Score (MSSS). A secondary analysis looked at predictors of EDSS sustained worsening at 6 months, defined as an increase of 1.5 if EDSS baseline was 0, 1.0 or more if baseline EDSS was 1.0-5.5, or 0.5 if baseline EDSS was over 5.5.

The researchers also conducted a sensitivity analysis that looked at relapse phenotypes and relapse frequency in the first year, as well as a subgroup analysis of patients with available MRI data from the first year. The researchers adjusted for time on high-efficacy DMTs at each visit.

Among the study participants, 70% were female. The median age of onset was 16 years. The median EDSS score was 1.5 at inclusion, and the median score was 1.0 at follow-up of 3 years. At 6 months, 82 worsening events occurred in 57 patients.

A total of 76% of the patients were treated with DMTs. The most commonly prescribed DMTs were interferon beta (40.63%), natalizumab (8.48%), and fingolimod (6.40%). Seventy-eight percent of those who received DMTs started treatment before age 18. Twenty-seven percent received high-efficacy DMTs.

The analysis showed associations between disability and older age at onset [exp(beta), 1.09; 95% confidence interval, 1.03-1.16], maximum EDSS score during the first year of disease [exp(beta), 1.25; 95% CI, 1.13-1.36], or first-year pyramidal symptoms [exp(beta), 1.34; 95% CI, 1.13-1.58], visual symptoms [exp(beta), 1.28; 95% CI, 1.10-1.48], or cerebellum symptoms [exp(beta), 1.17; 95% CI, 1.00-1.39]. A greater amount of time on high-efficacy DMTs was associated with a lower probability of disability [exp(beta), 0.96; 95% CI, 0.93-0.99].

A complete recovery from the first relapse was associated with a lower probability of relapse, though this association did not reach statistical significance [exp(beta), 0.83; 95% CI, 0.68-1.03].

The secondary analyses found that the only predictor of 6-month EDSS worsening [exp(beta), 1.32; 95% CI, 1.21-1.45] was having a maximum EDSS score in the first year. Sensitivity analyses of complete and incomplete recovery from relapses found that a higher MSSS was associated incomplete recovery [exp(beta), 1.16; 95% CI, 1.02-1.32], and confirmed the primary finding that recovery from first relapse was associated with a lower probability of disability [exp(beta), 0.78; 95% CI, 0.63-0.96].

Among patients with MRI data, a new MRI lesion in year 1 was associated with a lower future MSSS score [exp(beta), 0.81; 95% CI, 0.66-0.99].

The study was funded by the National Health and Medical Research Council of Australia. The study authors disclosed ties with a wide range of pharmaceutical companies, including Biogen and Novartis. Dr. Cree has consulted for Biogen, Novartis, and other pharmaceutical companies.

Among pediatric patients with multiple sclerosis (MS), some specific clinical characteristics, as well as treatment with disease-modifying therapies (DMTs), are linked to less future disability.

An estimated 3%-10% of MS patients are diagnosed during childhood. These patients experience a higher relapse rate and have higher magnetic resonance imaging (MRI) activity than do adult-onset patients. They have a slower rate of progression, but they reach irreversible disability milestones at an early age, with more than 50% having secondary progressive disease by age 30.

Studies in adults suggest that use of high-efficacy DMTs is most effective when initiated during the early active phase of MS, but little is known about children. “Early recognition of predictors of faster disability in children is crucial for clinicians to make the treatment decisions at the earliest possible time,” Sifat Sharmin, PhD, said during her presentation of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Sharmin is a statistician and research fellow at the University of Melbourne.
 

‘Reassuring’ data

“I think the most important observation that was made here is the protective factor of use of high efficacy disease modifying therapies,” said Bruce Cree, MD, PhD, who was asked to comment on the study.

That result wasn’t unexpected, but it should provide reassurance. “For parents of children who are hesitant about use of high efficacy therapies, this study provides supporting evidence for use of these high efficacy therapies early on, to try and prevent irreversible disability from occurring,” said Dr. Cree, professor of clinical neurology and the George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California at San Francisco UCSF Weill Institute for Neurosciences.

The study provides real-world data to back up findings from a phase 3 clinical trial that showed fewer relapses and fewer new lesions in pediatric patients with MS who were taking fingolimod versus interferon beta-1a.

“Given a large randomized, controlled trial, and now with this additional real-world data set showing the same thing, the only conclusion to reach is that if you’ve got a kid with MS, they should be treated with fingolimod,” said Dr. Cree. He noted that other DMTs such as natalizumab may also benefit pediatric patients, but fingolimod is the only drug that has been studied in randomized, controlled trials in children.

Real-world data

The researchers analyzed data from 672 patients drawn from the international MSBase Neuroimmunology Registry, who had undergone neurological assessment within 1 year of symptom onset and had at least two annual visits where the Expanded Disability Status Scale (EDSS) was recorded. They sought to identify predictors of Multiple Sclerosis Severity Score (MSSS). A secondary analysis looked at predictors of EDSS sustained worsening at 6 months, defined as an increase of 1.5 if EDSS baseline was 0, 1.0 or more if baseline EDSS was 1.0-5.5, or 0.5 if baseline EDSS was over 5.5.

The researchers also conducted a sensitivity analysis that looked at relapse phenotypes and relapse frequency in the first year, as well as a subgroup analysis of patients with available MRI data from the first year. The researchers adjusted for time on high-efficacy DMTs at each visit.

Among the study participants, 70% were female. The median age of onset was 16 years. The median EDSS score was 1.5 at inclusion, and the median score was 1.0 at follow-up of 3 years. At 6 months, 82 worsening events occurred in 57 patients.

A total of 76% of the patients were treated with DMTs. The most commonly prescribed DMTs were interferon beta (40.63%), natalizumab (8.48%), and fingolimod (6.40%). Seventy-eight percent of those who received DMTs started treatment before age 18. Twenty-seven percent received high-efficacy DMTs.

The analysis showed associations between disability and older age at onset [exp(beta), 1.09; 95% confidence interval, 1.03-1.16], maximum EDSS score during the first year of disease [exp(beta), 1.25; 95% CI, 1.13-1.36], or first-year pyramidal symptoms [exp(beta), 1.34; 95% CI, 1.13-1.58], visual symptoms [exp(beta), 1.28; 95% CI, 1.10-1.48], or cerebellum symptoms [exp(beta), 1.17; 95% CI, 1.00-1.39]. A greater amount of time on high-efficacy DMTs was associated with a lower probability of disability [exp(beta), 0.96; 95% CI, 0.93-0.99].

A complete recovery from the first relapse was associated with a lower probability of relapse, though this association did not reach statistical significance [exp(beta), 0.83; 95% CI, 0.68-1.03].

The secondary analyses found that the only predictor of 6-month EDSS worsening [exp(beta), 1.32; 95% CI, 1.21-1.45] was having a maximum EDSS score in the first year. Sensitivity analyses of complete and incomplete recovery from relapses found that a higher MSSS was associated incomplete recovery [exp(beta), 1.16; 95% CI, 1.02-1.32], and confirmed the primary finding that recovery from first relapse was associated with a lower probability of disability [exp(beta), 0.78; 95% CI, 0.63-0.96].

Among patients with MRI data, a new MRI lesion in year 1 was associated with a lower future MSSS score [exp(beta), 0.81; 95% CI, 0.66-0.99].

The study was funded by the National Health and Medical Research Council of Australia. The study authors disclosed ties with a wide range of pharmaceutical companies, including Biogen and Novartis. Dr. Cree has consulted for Biogen, Novartis, and other pharmaceutical companies.

Among pediatric patients with multiple sclerosis (MS), some specific clinical characteristics, as well as treatment with disease-modifying therapies (DMTs), are linked to less future disability.

An estimated 3%-10% of MS patients are diagnosed during childhood. These patients experience a higher relapse rate and have higher magnetic resonance imaging (MRI) activity than do adult-onset patients. They have a slower rate of progression, but they reach irreversible disability milestones at an early age, with more than 50% having secondary progressive disease by age 30.

Studies in adults suggest that use of high-efficacy DMTs is most effective when initiated during the early active phase of MS, but little is known about children. “Early recognition of predictors of faster disability in children is crucial for clinicians to make the treatment decisions at the earliest possible time,” Sifat Sharmin, PhD, said during her presentation of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Sharmin is a statistician and research fellow at the University of Melbourne.
 

‘Reassuring’ data

“I think the most important observation that was made here is the protective factor of use of high efficacy disease modifying therapies,” said Bruce Cree, MD, PhD, who was asked to comment on the study.

That result wasn’t unexpected, but it should provide reassurance. “For parents of children who are hesitant about use of high efficacy therapies, this study provides supporting evidence for use of these high efficacy therapies early on, to try and prevent irreversible disability from occurring,” said Dr. Cree, professor of clinical neurology and the George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California at San Francisco UCSF Weill Institute for Neurosciences.

The study provides real-world data to back up findings from a phase 3 clinical trial that showed fewer relapses and fewer new lesions in pediatric patients with MS who were taking fingolimod versus interferon beta-1a.

“Given a large randomized, controlled trial, and now with this additional real-world data set showing the same thing, the only conclusion to reach is that if you’ve got a kid with MS, they should be treated with fingolimod,” said Dr. Cree. He noted that other DMTs such as natalizumab may also benefit pediatric patients, but fingolimod is the only drug that has been studied in randomized, controlled trials in children.

Real-world data

The researchers analyzed data from 672 patients drawn from the international MSBase Neuroimmunology Registry, who had undergone neurological assessment within 1 year of symptom onset and had at least two annual visits where the Expanded Disability Status Scale (EDSS) was recorded. They sought to identify predictors of Multiple Sclerosis Severity Score (MSSS). A secondary analysis looked at predictors of EDSS sustained worsening at 6 months, defined as an increase of 1.5 if EDSS baseline was 0, 1.0 or more if baseline EDSS was 1.0-5.5, or 0.5 if baseline EDSS was over 5.5.

The researchers also conducted a sensitivity analysis that looked at relapse phenotypes and relapse frequency in the first year, as well as a subgroup analysis of patients with available MRI data from the first year. The researchers adjusted for time on high-efficacy DMTs at each visit.

Among the study participants, 70% were female. The median age of onset was 16 years. The median EDSS score was 1.5 at inclusion, and the median score was 1.0 at follow-up of 3 years. At 6 months, 82 worsening events occurred in 57 patients.

A total of 76% of the patients were treated with DMTs. The most commonly prescribed DMTs were interferon beta (40.63%), natalizumab (8.48%), and fingolimod (6.40%). Seventy-eight percent of those who received DMTs started treatment before age 18. Twenty-seven percent received high-efficacy DMTs.

The analysis showed associations between disability and older age at onset [exp(beta), 1.09; 95% confidence interval, 1.03-1.16], maximum EDSS score during the first year of disease [exp(beta), 1.25; 95% CI, 1.13-1.36], or first-year pyramidal symptoms [exp(beta), 1.34; 95% CI, 1.13-1.58], visual symptoms [exp(beta), 1.28; 95% CI, 1.10-1.48], or cerebellum symptoms [exp(beta), 1.17; 95% CI, 1.00-1.39]. A greater amount of time on high-efficacy DMTs was associated with a lower probability of disability [exp(beta), 0.96; 95% CI, 0.93-0.99].

A complete recovery from the first relapse was associated with a lower probability of relapse, though this association did not reach statistical significance [exp(beta), 0.83; 95% CI, 0.68-1.03].

The secondary analyses found that the only predictor of 6-month EDSS worsening [exp(beta), 1.32; 95% CI, 1.21-1.45] was having a maximum EDSS score in the first year. Sensitivity analyses of complete and incomplete recovery from relapses found that a higher MSSS was associated incomplete recovery [exp(beta), 1.16; 95% CI, 1.02-1.32], and confirmed the primary finding that recovery from first relapse was associated with a lower probability of disability [exp(beta), 0.78; 95% CI, 0.63-0.96].

Among patients with MRI data, a new MRI lesion in year 1 was associated with a lower future MSSS score [exp(beta), 0.81; 95% CI, 0.66-0.99].

The study was funded by the National Health and Medical Research Council of Australia. The study authors disclosed ties with a wide range of pharmaceutical companies, including Biogen and Novartis. Dr. Cree has consulted for Biogen, Novartis, and other pharmaceutical companies.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

The Diagnosis: Striated Muscle Hamartoma

Histopathologic evaluation revealed a dome-shaped papule with a center composed of mature striated muscle bundles, vellus hairs, sebaceous lobules, and nerve twigs (Figure) consistent with a diagnosis of striated muscle hamartoma (SMH).

Striated muscle hamartoma was first described in 1986 by Hendrick et al1 with 2 cases in neonates. Biopsies of the lesions taken from the upper lip and sternum showed a characteristic histology consisting of dermal striated muscle fibers and nerve bundles in the central core of the papules associated with a marked number of adnexa. In 1989, the diagnosis of rhabdomyomatous mesenchymal hamartoma was described, which showed similar findings.² Cases reported since these entities were discovered have used the terms striated muscle hamartoma and rhabdomyomatous mesenchymal hamartoma interchangeably.³

Most commonly found on the head and neck, SMH has now been observed in diverse locations including the sternum, hallux, vagina, and oral cavity.^1-15 Many reported cases describe lesions around or in the nose.^4,7,8 Multiple congenital anomalies have been described alongside SMH and may be associated with this entity including amniotic bands, cleft lip and palate, coloboma, and Delleman syndrome.^1,3,4 Almost all of the lesions present as a sessile or pedunculated papule, polyp, nodule, or plaque measuring from 0.3 cm up to 4.9 cm and typically are present since birth.^3,5,15 However, there are a few cases of lesions presenting in adults with no prior history.^5,6,15

Microscopically, SMH is defined by a dermal lesion with a core comprised of mature skeletal muscle admixed with adipose tissue, adnexa, nerve bundles, and fibrovascular tissue.¹ There are other entities that should be considered before making the diagnosis of SMH. Other hamartomas such as accessory tragus, connective tissue nevus, fibrous hamartoma of infancy, and nevus lipomatosis may present similarly; however, these lesions classically lack skeletal muscle. Benign triton tumors, or neuromuscular hamartomas, are rare lesions composed of skeletal muscle and abundant, intimately associated neural tissue. Neuromuscular hamartomas frequently involve large nerves.¹⁶ Rhabdomyomas also should be considered. Adult rhabdomyomas are composed of eosinophilic polygonal cells with granular cytoplasm and occasional cross-striations. Fetal rhabdomyomas have multiple histologic types and are defined by a variable myxoid stroma, eosinophilic spindled cells, and rhabdomyocytes in various stages of maturity. Genital rhabdomyomas histopathologically appear similar to fetal rhabdomyomas but are confined to the genital region. The skeletal muscle present in rhabdomyomas typically is less differentiated.¹⁷ TMature skeletal bundles should be a dominant component of the lesion before diagnosing SMH.

Typically presenting as congenital lesions in the head and neck region, papules with a dermal core of mature skeletal muscle associated with adnexa and nerve twigs should prompt consideration of a diagnosis of SMH or rhabdomyomatous mesenchymal hamartoma. These lesions are benign and usually are cured with complete excision.

The Diagnosis: Striated Muscle Hamartoma

Histopathologic evaluation revealed a dome-shaped papule with a center composed of mature striated muscle bundles, vellus hairs, sebaceous lobules, and nerve twigs (Figure) consistent with a diagnosis of striated muscle hamartoma (SMH).

Striated muscle hamartoma was first described in 1986 by Hendrick et al1 with 2 cases in neonates. Biopsies of the lesions taken from the upper lip and sternum showed a characteristic histology consisting of dermal striated muscle fibers and nerve bundles in the central core of the papules associated with a marked number of adnexa. In 1989, the diagnosis of rhabdomyomatous mesenchymal hamartoma was described, which showed similar findings.² Cases reported since these entities were discovered have used the terms striated muscle hamartoma and rhabdomyomatous mesenchymal hamartoma interchangeably.³

Most commonly found on the head and neck, SMH has now been observed in diverse locations including the sternum, hallux, vagina, and oral cavity.^1-15 Many reported cases describe lesions around or in the nose.^4,7,8 Multiple congenital anomalies have been described alongside SMH and may be associated with this entity including amniotic bands, cleft lip and palate, coloboma, and Delleman syndrome.^1,3,4 Almost all of the lesions present as a sessile or pedunculated papule, polyp, nodule, or plaque measuring from 0.3 cm up to 4.9 cm and typically are present since birth.^3,5,15 However, there are a few cases of lesions presenting in adults with no prior history.^5,6,15

Microscopically, SMH is defined by a dermal lesion with a core comprised of mature skeletal muscle admixed with adipose tissue, adnexa, nerve bundles, and fibrovascular tissue.¹ There are other entities that should be considered before making the diagnosis of SMH. Other hamartomas such as accessory tragus, connective tissue nevus, fibrous hamartoma of infancy, and nevus lipomatosis may present similarly; however, these lesions classically lack skeletal muscle. Benign triton tumors, or neuromuscular hamartomas, are rare lesions composed of skeletal muscle and abundant, intimately associated neural tissue. Neuromuscular hamartomas frequently involve large nerves.¹⁶ Rhabdomyomas also should be considered. Adult rhabdomyomas are composed of eosinophilic polygonal cells with granular cytoplasm and occasional cross-striations. Fetal rhabdomyomas have multiple histologic types and are defined by a variable myxoid stroma, eosinophilic spindled cells, and rhabdomyocytes in various stages of maturity. Genital rhabdomyomas histopathologically appear similar to fetal rhabdomyomas but are confined to the genital region. The skeletal muscle present in rhabdomyomas typically is less differentiated.¹⁷ TMature skeletal bundles should be a dominant component of the lesion before diagnosing SMH.

Typically presenting as congenital lesions in the head and neck region, papules with a dermal core of mature skeletal muscle associated with adnexa and nerve twigs should prompt consideration of a diagnosis of SMH or rhabdomyomatous mesenchymal hamartoma. These lesions are benign and usually are cured with complete excision.

The Diagnosis: Striated Muscle Hamartoma

Histopathologic evaluation revealed a dome-shaped papule with a center composed of mature striated muscle bundles, vellus hairs, sebaceous lobules, and nerve twigs (Figure) consistent with a diagnosis of striated muscle hamartoma (SMH).

Striated muscle hamartoma was first described in 1986 by Hendrick et al1 with 2 cases in neonates. Biopsies of the lesions taken from the upper lip and sternum showed a characteristic histology consisting of dermal striated muscle fibers and nerve bundles in the central core of the papules associated with a marked number of adnexa. In 1989, the diagnosis of rhabdomyomatous mesenchymal hamartoma was described, which showed similar findings.² Cases reported since these entities were discovered have used the terms striated muscle hamartoma and rhabdomyomatous mesenchymal hamartoma interchangeably.³

Most commonly found on the head and neck, SMH has now been observed in diverse locations including the sternum, hallux, vagina, and oral cavity.^1-15 Many reported cases describe lesions around or in the nose.^4,7,8 Multiple congenital anomalies have been described alongside SMH and may be associated with this entity including amniotic bands, cleft lip and palate, coloboma, and Delleman syndrome.^1,3,4 Almost all of the lesions present as a sessile or pedunculated papule, polyp, nodule, or plaque measuring from 0.3 cm up to 4.9 cm and typically are present since birth.^3,5,15 However, there are a few cases of lesions presenting in adults with no prior history.^5,6,15

Microscopically, SMH is defined by a dermal lesion with a core comprised of mature skeletal muscle admixed with adipose tissue, adnexa, nerve bundles, and fibrovascular tissue.¹ There are other entities that should be considered before making the diagnosis of SMH. Other hamartomas such as accessory tragus, connective tissue nevus, fibrous hamartoma of infancy, and nevus lipomatosis may present similarly; however, these lesions classically lack skeletal muscle. Benign triton tumors, or neuromuscular hamartomas, are rare lesions composed of skeletal muscle and abundant, intimately associated neural tissue. Neuromuscular hamartomas frequently involve large nerves.¹⁶ Rhabdomyomas also should be considered. Adult rhabdomyomas are composed of eosinophilic polygonal cells with granular cytoplasm and occasional cross-striations. Fetal rhabdomyomas have multiple histologic types and are defined by a variable myxoid stroma, eosinophilic spindled cells, and rhabdomyocytes in various stages of maturity. Genital rhabdomyomas histopathologically appear similar to fetal rhabdomyomas but are confined to the genital region. The skeletal muscle present in rhabdomyomas typically is less differentiated.¹⁷ TMature skeletal bundles should be a dominant component of the lesion before diagnosing SMH.

Typically presenting as congenital lesions in the head and neck region, papules with a dermal core of mature skeletal muscle associated with adnexa and nerve twigs should prompt consideration of a diagnosis of SMH or rhabdomyomatous mesenchymal hamartoma. These lesions are benign and usually are cured with complete excision.

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

A biopsy of the lesion was performed which showed an increased number of eccrine glands and blood vessels within the dermis. Some areas showed an increase in adipocytes and smooth muscle bundles. The changes were consistent with eccrine angiomatous hamartoma (EAH).

The boy was referred to vascular laser therapy for treatment of the lesion.

EAH is a rare benign vascular growth characterized by an increased number of mature eccrine glands and blood vessels in the dermis and subcutis. The lesions are mostly present on the extremities, but cases of diffuse congenital lesions and lesions on the face and trunk have also been described. The lesions can be seen at birth or during the first years of life in about half of the cases, and the others tend to occur later in puberty and rarely in adulthood^.1

Clinically, EAH lesions present as red, yellow to brown papules and plaques. Different dermoscopic patterns have been described which include the popcorn pattern that presents as yellow, confluent nodules with popcornlike shapes over a background of erythema, and linear arborizing vessels. The spitzoid pattern are brown globules on a background of erythema and pseudoreticular pigmentation around the globules. The verrucous hemangiomalike pattern has a bluish-white hue, reddish-blue or bluish lacunae, as seen in our patient.^2-4

Most of the lesions are asymptomatic, but in some patients, they can be associated with pain, hyperhidrosis, and sometimes bleeding. Hyperhidrosis has been reported early in the presentation or during puberty or pregnancy. Our patient had started on amphetamines when hyperhidrosis occurred. Hyperhidrosis is a knowns side effect of this type of medication and may have had a role in the increased sweating noted on the hamartoma.

EAH can clinically look like verrucous hemangiomas, angiokeratomas, and vascular malformations, and histopathology may be needed to differentiate between them. Eccrine nevi and EAH can be similar. Hyperhidrosis is an early and predominant component of eccrine nevi, compared with one-third of EAH.

The exact etiology of this lesion is not known. It is thought to be caused by an abnormal differentiation of the epithelium, adnexal structure, and the mesenchyme during organogenesis.³ No other associated conditions have been described with EAH.

EAH are benign lesions that rarely require treatment. If the lesions are symptomatic or because of cosmetic reasons, they can be removed surgically. There are some reports of successful treatment with pulse dual-wavelength sequential 595- and 1064-nm lasers.⁵ Botulinum toxin has also been used in cases of symptomatic hyperhidrosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She has no conflicts. Email her at [email protected].

References

1. Smith SD et al. Pediatr Dermatol. 2019 Nov;36(6):909-12.

2. Patterson AT et al. Am J Dermatopathol. 2016;38:413-7.

3. Garcıa-Garcıa SC et al. JAAD Case Rep. 2018;4(2):165-7.

4. Awatef Kelati et al. JAAD Case Rep. 2018;4(8)835-6.

5. Felgueiras J et al. Dermatol Surg. 2015 Mar;41(3):428-30.

A biopsy of the lesion was performed which showed an increased number of eccrine glands and blood vessels within the dermis. Some areas showed an increase in adipocytes and smooth muscle bundles. The changes were consistent with eccrine angiomatous hamartoma (EAH).

The boy was referred to vascular laser therapy for treatment of the lesion.

EAH is a rare benign vascular growth characterized by an increased number of mature eccrine glands and blood vessels in the dermis and subcutis. The lesions are mostly present on the extremities, but cases of diffuse congenital lesions and lesions on the face and trunk have also been described. The lesions can be seen at birth or during the first years of life in about half of the cases, and the others tend to occur later in puberty and rarely in adulthood^.1

Clinically, EAH lesions present as red, yellow to brown papules and plaques. Different dermoscopic patterns have been described which include the popcorn pattern that presents as yellow, confluent nodules with popcornlike shapes over a background of erythema, and linear arborizing vessels. The spitzoid pattern are brown globules on a background of erythema and pseudoreticular pigmentation around the globules. The verrucous hemangiomalike pattern has a bluish-white hue, reddish-blue or bluish lacunae, as seen in our patient.^2-4

Most of the lesions are asymptomatic, but in some patients, they can be associated with pain, hyperhidrosis, and sometimes bleeding. Hyperhidrosis has been reported early in the presentation or during puberty or pregnancy. Our patient had started on amphetamines when hyperhidrosis occurred. Hyperhidrosis is a knowns side effect of this type of medication and may have had a role in the increased sweating noted on the hamartoma.

EAH can clinically look like verrucous hemangiomas, angiokeratomas, and vascular malformations, and histopathology may be needed to differentiate between them. Eccrine nevi and EAH can be similar. Hyperhidrosis is an early and predominant component of eccrine nevi, compared with one-third of EAH.

The exact etiology of this lesion is not known. It is thought to be caused by an abnormal differentiation of the epithelium, adnexal structure, and the mesenchyme during organogenesis.³ No other associated conditions have been described with EAH.

EAH are benign lesions that rarely require treatment. If the lesions are symptomatic or because of cosmetic reasons, they can be removed surgically. There are some reports of successful treatment with pulse dual-wavelength sequential 595- and 1064-nm lasers.⁵ Botulinum toxin has also been used in cases of symptomatic hyperhidrosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She has no conflicts. Email her at [email protected].

References

1. Smith SD et al. Pediatr Dermatol. 2019 Nov;36(6):909-12.

2. Patterson AT et al. Am J Dermatopathol. 2016;38:413-7.

3. Garcıa-Garcıa SC et al. JAAD Case Rep. 2018;4(2):165-7.

4. Awatef Kelati et al. JAAD Case Rep. 2018;4(8)835-6.

5. Felgueiras J et al. Dermatol Surg. 2015 Mar;41(3):428-30.

A biopsy of the lesion was performed which showed an increased number of eccrine glands and blood vessels within the dermis. Some areas showed an increase in adipocytes and smooth muscle bundles. The changes were consistent with eccrine angiomatous hamartoma (EAH).

The boy was referred to vascular laser therapy for treatment of the lesion.

EAH is a rare benign vascular growth characterized by an increased number of mature eccrine glands and blood vessels in the dermis and subcutis. The lesions are mostly present on the extremities, but cases of diffuse congenital lesions and lesions on the face and trunk have also been described. The lesions can be seen at birth or during the first years of life in about half of the cases, and the others tend to occur later in puberty and rarely in adulthood^.1

Clinically, EAH lesions present as red, yellow to brown papules and plaques. Different dermoscopic patterns have been described which include the popcorn pattern that presents as yellow, confluent nodules with popcornlike shapes over a background of erythema, and linear arborizing vessels. The spitzoid pattern are brown globules on a background of erythema and pseudoreticular pigmentation around the globules. The verrucous hemangiomalike pattern has a bluish-white hue, reddish-blue or bluish lacunae, as seen in our patient.^2-4

Most of the lesions are asymptomatic, but in some patients, they can be associated with pain, hyperhidrosis, and sometimes bleeding. Hyperhidrosis has been reported early in the presentation or during puberty or pregnancy. Our patient had started on amphetamines when hyperhidrosis occurred. Hyperhidrosis is a knowns side effect of this type of medication and may have had a role in the increased sweating noted on the hamartoma.

EAH can clinically look like verrucous hemangiomas, angiokeratomas, and vascular malformations, and histopathology may be needed to differentiate between them. Eccrine nevi and EAH can be similar. Hyperhidrosis is an early and predominant component of eccrine nevi, compared with one-third of EAH.

The exact etiology of this lesion is not known. It is thought to be caused by an abnormal differentiation of the epithelium, adnexal structure, and the mesenchyme during organogenesis.³ No other associated conditions have been described with EAH.

EAH are benign lesions that rarely require treatment. If the lesions are symptomatic or because of cosmetic reasons, they can be removed surgically. There are some reports of successful treatment with pulse dual-wavelength sequential 595- and 1064-nm lasers.⁵ Botulinum toxin has also been used in cases of symptomatic hyperhidrosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She has no conflicts. Email her at [email protected].

References

1. Smith SD et al. Pediatr Dermatol. 2019 Nov;36(6):909-12.

2. Patterson AT et al. Am J Dermatopathol. 2016;38:413-7.

3. Garcıa-Garcıa SC et al. JAAD Case Rep. 2018;4(2):165-7.

4. Awatef Kelati et al. JAAD Case Rep. 2018;4(8)835-6.

5. Felgueiras J et al. Dermatol Surg. 2015 Mar;41(3):428-30.

As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.

Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.

During the week ending Oct. 18, almost 125,000 children aged 12-17 years received a dose of vaccine – that’s about 20% of the highest number seen when vaccinations spiked in August and just 7.4% of the peak recorded during May 18-24 (nearly 1.7 million doses), when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.

Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.

Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.

The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.

[email protected]

As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.

Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.

During the week ending Oct. 18, almost 125,000 children aged 12-17 years received a dose of vaccine – that’s about 20% of the highest number seen when vaccinations spiked in August and just 7.4% of the peak recorded during May 18-24 (nearly 1.7 million doses), when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.

Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.

Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.

The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.

[email protected]

As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.

Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.

During the week ending Oct. 18, almost 125,000 children aged 12-17 years received a dose of vaccine – that’s about 20% of the highest number seen when vaccinations spiked in August and just 7.4% of the peak recorded during May 18-24 (nearly 1.7 million doses), when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.

Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.

Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.

The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.

[email protected]

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

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

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

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

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.

Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.

The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.

The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

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