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New data support a causal role for depression in Alzheimer’s
Researchers have known for some time that depression is associated with Alzheimer’s disease (AD), but a causal link has been elusive. Now, using newly available data, they have uncovered genetic evidence of a causal role for depression in AD.
As depression typically affects those in early or midlife and dementia often occurs in later life, “it’s fascinating to see a connection between the two brain illnesses that manifest in different time windows,” coinvestigator Aliza P. Wingo, MD, associate professor of psychiatry and behavioral science, Emory University, Atlanta, said in an interview.
“If we can treat the depression early on, we may help reduce risk for dementia for our patients later in life,” Dr. Wingo said.
The findings were published online Dec. 16, 2021, in Biological Psychiatry.
Postmortem data
The investigators, who are all from the Emory University Center for Neurodegenerative Disease, wanted to clarify the genetic basis underlying the association between the established link between depression and dementia risk.
They used data from the largest and most recent genomewide association studies (GWAS). These included a 2019 analysis of depression among 807,553 individuals and a 2019 study of AD among 455,258 individuals, all of European ancestry. For sensitivity analyses, they used results from two additional AD GWAS.
The researchers also accessed postmortem brain samples from participants in the Religious Orders Study (ROS) and the Rush Memory and Aging Project (MAP). These participants were cognitively normal at enrollment, underwent annual clinical evaluations, and agreed to donate their brains.
They also assessed brain samples donated by participants in the Banner Sun Health Research Institute longitudinal study of healthy aging, Alzheimer’s, and Parkinson’s disease.
The brain samples allowed researchers to use deep brain proteomic data to help determine molecular links between depression and AD.
After quality control, the analysis included 8,356 proteins in 391 ROS/MAP participants and 7,854 proteins in 196 Banner participants.
suggesting the two conditions have a shared genetic basis.
The investigators also applied a framework called “Mendelian randomization” to determine causality between depression and AD.
After assessing the effect of 115 independent single-nucleotide polymorphisms (SNPs) from the GWAS of depression, they uncovered significant evidence “that the SNPs cause depression, which in turn cause AD,” said Dr. Wingo.
One-way relationship
The researchers conducted the same analysis on 61 significant SNPs from the GWAS of AD but did not find evidence to conclude AD causes depression.
“We found genetic evidence supporting a causal role of depression in AD but not vice versa,” Dr. Wingo said.
In addition, the investigators identified 75 brain transcripts (messenger RNA) and 28 brain proteins regulated by the depression-predisposing genetic variants. Of these, 46 brain transcripts and seven proteins were significantly associated with at least one AD feature – for example, beta-amyloid, tau tangles, and cognitive trajectory.
“These findings support the notion that the depression risk variants contribute to AD via regulating expression of their corresponding transcripts in the brain,” the investigators wrote.
It is only recently that large enough studies have allowed researchers sufficient power to reach these conclusions, coinvestigator Thomas Wingo, MD, said in an interview.
These additional “insights” into the relationship between depression and AD might “motivate” clinicians more to screen for and treat depressive symptoms, Dr. Aliza Wingo noted.
The new results also have implications for developing therapeutics to treat depression, she said. “If we target the genes, the brain proteins, that are shared risk between depression and AD, the medications that target that gene might mitigate risk for AD later on.”
However, the investigators advised caution. “A lot of this is still unknown,” said Dr. Thomas Wingo.
For example, it is not clear whether successfully treating depression mitigates the eventual risk of dementia, which is “a very important topic of inquiry and one we continue to work on,” he said, adding that a significant number of patients do not respond well to existing antidepressants such as SSRIs.
Need for further research
Commenting on the findings, Claire Sexton, DPhil, director of scientific programs and outreach, Alzheimer’s Association, said the study contributes to the debate about whether depression increases risk for AD, whether AD increases risk for depression, or both.
“These newly published findings strengthen our understanding of the role of depression as a risk factor for Alzheimer’s dementia,” said Dr. Sexton, who was not involved with the research.
While experts do not yet fully understand the impact of treating depression on dementia risk, “the findings emphasize the importance of assessing mental health status, particularly depression, and getting it properly diagnosed and treated in a timely manner,” she said.
However, she agreed more research in this area is needed. “Importantly, these findings need replication in broader, more diverse study populations,” Dr. Sexton said.
A study funded by the Alzheimer’s Association may provide more information on the link between depression and AD. It will investigate whether machine learning, an advanced computer science technique, can better predict cognitive decline, compared with traditional methods.
Over a period of 6 months, researchers will collect smartphone conversations from 225 older adults with dementia, mild cognitive impairment, or no cognitive impairment. They will also have data from cognitive tests, brain scans, and biomarkers such as cerebrospinal fluid samples to study brain changes associated with AD.
The novel method of analysis should be able to identify subtle differences in speech quality to indicate which depressive symptoms an individual might be experiencing.
“The study could help us further understand the potential impact of depression in the risk of developing dementia,” said Dr. Sexton.
Dr. Aliza Wingo and Dr. Thomas Wingo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers have known for some time that depression is associated with Alzheimer’s disease (AD), but a causal link has been elusive. Now, using newly available data, they have uncovered genetic evidence of a causal role for depression in AD.
As depression typically affects those in early or midlife and dementia often occurs in later life, “it’s fascinating to see a connection between the two brain illnesses that manifest in different time windows,” coinvestigator Aliza P. Wingo, MD, associate professor of psychiatry and behavioral science, Emory University, Atlanta, said in an interview.
“If we can treat the depression early on, we may help reduce risk for dementia for our patients later in life,” Dr. Wingo said.
The findings were published online Dec. 16, 2021, in Biological Psychiatry.
Postmortem data
The investigators, who are all from the Emory University Center for Neurodegenerative Disease, wanted to clarify the genetic basis underlying the association between the established link between depression and dementia risk.
They used data from the largest and most recent genomewide association studies (GWAS). These included a 2019 analysis of depression among 807,553 individuals and a 2019 study of AD among 455,258 individuals, all of European ancestry. For sensitivity analyses, they used results from two additional AD GWAS.
The researchers also accessed postmortem brain samples from participants in the Religious Orders Study (ROS) and the Rush Memory and Aging Project (MAP). These participants were cognitively normal at enrollment, underwent annual clinical evaluations, and agreed to donate their brains.
They also assessed brain samples donated by participants in the Banner Sun Health Research Institute longitudinal study of healthy aging, Alzheimer’s, and Parkinson’s disease.
The brain samples allowed researchers to use deep brain proteomic data to help determine molecular links between depression and AD.
After quality control, the analysis included 8,356 proteins in 391 ROS/MAP participants and 7,854 proteins in 196 Banner participants.
suggesting the two conditions have a shared genetic basis.
The investigators also applied a framework called “Mendelian randomization” to determine causality between depression and AD.
After assessing the effect of 115 independent single-nucleotide polymorphisms (SNPs) from the GWAS of depression, they uncovered significant evidence “that the SNPs cause depression, which in turn cause AD,” said Dr. Wingo.
One-way relationship
The researchers conducted the same analysis on 61 significant SNPs from the GWAS of AD but did not find evidence to conclude AD causes depression.
“We found genetic evidence supporting a causal role of depression in AD but not vice versa,” Dr. Wingo said.
In addition, the investigators identified 75 brain transcripts (messenger RNA) and 28 brain proteins regulated by the depression-predisposing genetic variants. Of these, 46 brain transcripts and seven proteins were significantly associated with at least one AD feature – for example, beta-amyloid, tau tangles, and cognitive trajectory.
“These findings support the notion that the depression risk variants contribute to AD via regulating expression of their corresponding transcripts in the brain,” the investigators wrote.
It is only recently that large enough studies have allowed researchers sufficient power to reach these conclusions, coinvestigator Thomas Wingo, MD, said in an interview.
These additional “insights” into the relationship between depression and AD might “motivate” clinicians more to screen for and treat depressive symptoms, Dr. Aliza Wingo noted.
The new results also have implications for developing therapeutics to treat depression, she said. “If we target the genes, the brain proteins, that are shared risk between depression and AD, the medications that target that gene might mitigate risk for AD later on.”
However, the investigators advised caution. “A lot of this is still unknown,” said Dr. Thomas Wingo.
For example, it is not clear whether successfully treating depression mitigates the eventual risk of dementia, which is “a very important topic of inquiry and one we continue to work on,” he said, adding that a significant number of patients do not respond well to existing antidepressants such as SSRIs.
Need for further research
Commenting on the findings, Claire Sexton, DPhil, director of scientific programs and outreach, Alzheimer’s Association, said the study contributes to the debate about whether depression increases risk for AD, whether AD increases risk for depression, or both.
“These newly published findings strengthen our understanding of the role of depression as a risk factor for Alzheimer’s dementia,” said Dr. Sexton, who was not involved with the research.
While experts do not yet fully understand the impact of treating depression on dementia risk, “the findings emphasize the importance of assessing mental health status, particularly depression, and getting it properly diagnosed and treated in a timely manner,” she said.
However, she agreed more research in this area is needed. “Importantly, these findings need replication in broader, more diverse study populations,” Dr. Sexton said.
A study funded by the Alzheimer’s Association may provide more information on the link between depression and AD. It will investigate whether machine learning, an advanced computer science technique, can better predict cognitive decline, compared with traditional methods.
Over a period of 6 months, researchers will collect smartphone conversations from 225 older adults with dementia, mild cognitive impairment, or no cognitive impairment. They will also have data from cognitive tests, brain scans, and biomarkers such as cerebrospinal fluid samples to study brain changes associated with AD.
The novel method of analysis should be able to identify subtle differences in speech quality to indicate which depressive symptoms an individual might be experiencing.
“The study could help us further understand the potential impact of depression in the risk of developing dementia,” said Dr. Sexton.
Dr. Aliza Wingo and Dr. Thomas Wingo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers have known for some time that depression is associated with Alzheimer’s disease (AD), but a causal link has been elusive. Now, using newly available data, they have uncovered genetic evidence of a causal role for depression in AD.
As depression typically affects those in early or midlife and dementia often occurs in later life, “it’s fascinating to see a connection between the two brain illnesses that manifest in different time windows,” coinvestigator Aliza P. Wingo, MD, associate professor of psychiatry and behavioral science, Emory University, Atlanta, said in an interview.
“If we can treat the depression early on, we may help reduce risk for dementia for our patients later in life,” Dr. Wingo said.
The findings were published online Dec. 16, 2021, in Biological Psychiatry.
Postmortem data
The investigators, who are all from the Emory University Center for Neurodegenerative Disease, wanted to clarify the genetic basis underlying the association between the established link between depression and dementia risk.
They used data from the largest and most recent genomewide association studies (GWAS). These included a 2019 analysis of depression among 807,553 individuals and a 2019 study of AD among 455,258 individuals, all of European ancestry. For sensitivity analyses, they used results from two additional AD GWAS.
The researchers also accessed postmortem brain samples from participants in the Religious Orders Study (ROS) and the Rush Memory and Aging Project (MAP). These participants were cognitively normal at enrollment, underwent annual clinical evaluations, and agreed to donate their brains.
They also assessed brain samples donated by participants in the Banner Sun Health Research Institute longitudinal study of healthy aging, Alzheimer’s, and Parkinson’s disease.
The brain samples allowed researchers to use deep brain proteomic data to help determine molecular links between depression and AD.
After quality control, the analysis included 8,356 proteins in 391 ROS/MAP participants and 7,854 proteins in 196 Banner participants.
suggesting the two conditions have a shared genetic basis.
The investigators also applied a framework called “Mendelian randomization” to determine causality between depression and AD.
After assessing the effect of 115 independent single-nucleotide polymorphisms (SNPs) from the GWAS of depression, they uncovered significant evidence “that the SNPs cause depression, which in turn cause AD,” said Dr. Wingo.
One-way relationship
The researchers conducted the same analysis on 61 significant SNPs from the GWAS of AD but did not find evidence to conclude AD causes depression.
“We found genetic evidence supporting a causal role of depression in AD but not vice versa,” Dr. Wingo said.
In addition, the investigators identified 75 brain transcripts (messenger RNA) and 28 brain proteins regulated by the depression-predisposing genetic variants. Of these, 46 brain transcripts and seven proteins were significantly associated with at least one AD feature – for example, beta-amyloid, tau tangles, and cognitive trajectory.
“These findings support the notion that the depression risk variants contribute to AD via regulating expression of their corresponding transcripts in the brain,” the investigators wrote.
It is only recently that large enough studies have allowed researchers sufficient power to reach these conclusions, coinvestigator Thomas Wingo, MD, said in an interview.
These additional “insights” into the relationship between depression and AD might “motivate” clinicians more to screen for and treat depressive symptoms, Dr. Aliza Wingo noted.
The new results also have implications for developing therapeutics to treat depression, she said. “If we target the genes, the brain proteins, that are shared risk between depression and AD, the medications that target that gene might mitigate risk for AD later on.”
However, the investigators advised caution. “A lot of this is still unknown,” said Dr. Thomas Wingo.
For example, it is not clear whether successfully treating depression mitigates the eventual risk of dementia, which is “a very important topic of inquiry and one we continue to work on,” he said, adding that a significant number of patients do not respond well to existing antidepressants such as SSRIs.
Need for further research
Commenting on the findings, Claire Sexton, DPhil, director of scientific programs and outreach, Alzheimer’s Association, said the study contributes to the debate about whether depression increases risk for AD, whether AD increases risk for depression, or both.
“These newly published findings strengthen our understanding of the role of depression as a risk factor for Alzheimer’s dementia,” said Dr. Sexton, who was not involved with the research.
While experts do not yet fully understand the impact of treating depression on dementia risk, “the findings emphasize the importance of assessing mental health status, particularly depression, and getting it properly diagnosed and treated in a timely manner,” she said.
However, she agreed more research in this area is needed. “Importantly, these findings need replication in broader, more diverse study populations,” Dr. Sexton said.
A study funded by the Alzheimer’s Association may provide more information on the link between depression and AD. It will investigate whether machine learning, an advanced computer science technique, can better predict cognitive decline, compared with traditional methods.
Over a period of 6 months, researchers will collect smartphone conversations from 225 older adults with dementia, mild cognitive impairment, or no cognitive impairment. They will also have data from cognitive tests, brain scans, and biomarkers such as cerebrospinal fluid samples to study brain changes associated with AD.
The novel method of analysis should be able to identify subtle differences in speech quality to indicate which depressive symptoms an individual might be experiencing.
“The study could help us further understand the potential impact of depression in the risk of developing dementia,” said Dr. Sexton.
Dr. Aliza Wingo and Dr. Thomas Wingo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BIOLOGICAL PSYCHIATRY
Even healthy Black and Hispanic women have more cesareans than White women
New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.
“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.
Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”
One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.
For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).
A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).
The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.
The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”
The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.
The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”
“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.
The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”
Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”
She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”
The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.
New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.
“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.
Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”
One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.
For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).
A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).
The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.
The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”
The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.
The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”
“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.
The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”
Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”
She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”
The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.
New research offers more insight into potentially dangerous racial disparities in cesarean deliveries: In first-time live births, healthy African-American and Hispanic mothers were 21% and 26% more likely than White mothers, respectively, to deliver by cesarean section despite being low risk. The higher number of cesareans appeared to boost their risk of morbidity.
“A 20% increased odds of cesarean among otherwise healthy, low-risk, nulliparous individuals at term – with limited medical or obstetric explanation – is a significant concern, especially when considering that cesarean is the most common surgical procedure in the U.S.,” said study author Michelle P. Debbink, MD, PhD, an assistant professor with the department of obstetrics and gynecology at the University of Utah, in an interview.
Dr. Debbink and colleagues launched the study, published in the Jan. 2022 issue of Obstetrics & Gynecology, to better understand the racial gap in cesarean sections, which are considered riskier than vaginal deliveries. “Several studies have shown that Black women undergo cesarean more frequently than non-Hispanic White women. Numerous studies also show that Hispanic/Latina women undergo cesarean more frequently than White women, although these data are a bit more mixed,” she said. “What we don’t know, however, is why these differences occur and whether there are clues in the data which can point us toward interventions to close the gap.”
One theory, she said, is that Black and Hispanic women have more comorbidities and therefore more cesareans. To test that idea, the researchers found a cohort of healthy women in a randomized trial that studied the induction of labor.
For the study, they focused on 5,759 women (24.3% Black, 30% Hispanic, 46.6% White). Major differences between the groups included maternal age (average = 21 for Black, 22 for Hispanic, and 26 for White, P < .001), private insurance (17% for Black and Hispanic, 75% for White; P < .001), and full or part-time employment (37% for Black, 31% for Hispanic, and 71% for White; P < .001).
A total of 1,158 of the women (20.1%) underwent cesarean deliveries, accounting for 23% of deliveries by Black women, 22.8% of those by Hispanic women, and 17.6% of those by White women (P < .001). Black women were 21% more likely than White women to give birth via cesarean (adjusted relative risk = 1.21, 95% CI: 1.03-1.42) and Hispanic women were 26% more likely (aRR = 1.26, 95% CI: 1.08-1.46).
The study doesn’t explore why Black and Hispanic women have more cesarean deliveries. However, Dr. Debbink said, “we hypothesize that the difference likely stems more from differing treatment of Black or Hispanic individuals during labor.” It’s unlikely, she said, that these women are more likely to prefer cesarean sections. For one thing, she said, other research hasn’t shown a difference in preferences by race.
The researchers also analyzed maternal morbidity, defined as “transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death.”
The study found that while few women (2.3%) suffered from morbidity, Black (aRR = 2.05, 95% CI: 1.21-3.47) and Hispanic (aRR = 1.92, 95% CI: 1.17-3.14) women were more likely to suffer from it than White women.
The researchers report that “cesarean birth accounted for an estimated 15.8% (95% CI: 2.1%-48.7%) and 16.5% (95% CI: 4.0%-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.”
“Both endometritis and wound complications are much more common among individuals with cesarean, and blood clots, hysterectomy, and ICU admission are also more common after cesarean compared with vaginal delivery,” Dr. Debbink said.
The message of the study, she said, is that the health care system “perpetuates gaps in cesarean delivery for Black and Hispanic individuals compared to White individuals” even in low-risk, first-time live births. “We do not yet know exactly what the right levers are to address this gap, but it is important that we ob-gyns examine our practice patterns and our hospitals’ practice patterns to ensure equity for all our patients.”
Rebecca Delafield, PhD, an assistant professor of Native Hawaiian Health at the University of Hawaii, praised the study as “well-conducted” in an interview. “I agree with the assessment that while the cesarean delivery accounts for a modest proportion of excess morbidity in this study, the impact at the population level is significant,” said Dr. Delafield, who studies health disparities and didn’t take part in the study. “Delivery is complex and the causes of disparities observed are likely multifactorial, therefore research such as this is necessary and compelling.”
She added: “It is becoming increasingly evident that studies investigating racial/ethnic disparities in cesarean delivery and other maternal health outcomes must look beyond maternal behavioral or medical risk factors – e.g., obesity or hypertension – and consider the contribution of a broader set of factors, including societal prejudices.”
The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. One study author reports funding from GlaxoSmithKline, Pfizer, Moderna, and UpToDate (contributor) and from the Centers for Disease Control and Prevention (via her institution). Dr. Debbink, the other authors, and Dr. Delafield report no disclosures.
FROM OBSTETRICS & GYNECOLOGY
FDA approves first-in-class inclisiran to lower LDL-C
The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.
The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.
Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.
Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.
The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.
Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.
The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.
Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.
Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.
The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.
Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.
The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.
Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.
Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.
The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.
Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”
A version of this article first appeared on Medscape.com.
Serious problems rare in ages 5-11 from COVID vaccine
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
FDA backs Pfizer booster for 12- to 15-year-olds
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Travel/school disruptions as COVID-19 cases grow in 2022
As the United States enters a third year of the COVID-19 pandemic,
The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.
New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.
“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.
“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.
The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.
In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.
About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.
More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.
“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.
The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.
American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.
“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.
K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.
“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.
This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.
A version of this article first appeared on WebMD.com.
As the United States enters a third year of the COVID-19 pandemic,
The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.
New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.
“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.
“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.
The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.
In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.
About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.
More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.
“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.
The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.
American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.
“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.
K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.
“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.
This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.
A version of this article first appeared on WebMD.com.
As the United States enters a third year of the COVID-19 pandemic,
The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.
New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.
“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.
“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.
The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.
In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.
About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.
More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.
“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.
The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.
American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.
“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.
K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.
“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.
This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.
A version of this article first appeared on WebMD.com.
Antiretroviral pill better at suppressing HIV in children
Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.
The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.
“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.
“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
Study details
The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.
The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.
“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.
“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
Simplified dosing
“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”
Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.
Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.
The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.
A version of this article first appeared on Medscape.com.
Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.
The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.
“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.
“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
Study details
The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.
The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.
“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.
“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
Simplified dosing
“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”
Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.
Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.
The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.
A version of this article first appeared on Medscape.com.
Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.
The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.
“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.
“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
Study details
The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.
The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.
“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.
“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
Simplified dosing
“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”
Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.
Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.
The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Pandemic screen time linked to anxiety, depression in older kids
However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.
Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.
The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).
Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.
“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.
For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.
In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).
However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.
Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).
“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”
More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.
The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.
Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.
Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
Bad news or bad stats?
Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”
Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”
Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.
Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”
The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.
Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.
The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).
Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.
“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.
For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.
In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).
However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.
Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).
“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”
More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.
The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.
Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.
Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
Bad news or bad stats?
Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”
Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”
Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.
Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”
The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.
Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.
The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).
Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.
“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.
For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.
In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).
However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.
Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).
“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”
More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.
The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.
Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.
Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
Bad news or bad stats?
Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”
Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”
Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.
Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”
The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Medicaid implements waivers for some clinical trial coverage
Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.
Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.
Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.
‘A hidden opportunity’
A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.
In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.
“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”
In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.
In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.
But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.
“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.
A version of this article first appeared on Medscape.com.
Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.
Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.
Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.
‘A hidden opportunity’
A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.
In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.
“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”
In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.
In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.
But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.
“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.
A version of this article first appeared on Medscape.com.
Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.
Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.
Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.
‘A hidden opportunity’
A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.
In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.
“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”
In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.
In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.
But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.
“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.
A version of this article first appeared on Medscape.com.
Breast cancer treatment worse for incarcerated patients
The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).
Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.
They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.
“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.
Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”
Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”
The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”
Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.
Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.
The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).
“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.
No funding or relevant financial relationships were declared for this featured study.
The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).
Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.
They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.
“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.
Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”
Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”
The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”
Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.
Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.
The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).
“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.
No funding or relevant financial relationships were declared for this featured study.
The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).
Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.
They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.
“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.
Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”
Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”
The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”
Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.
Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.
The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).
“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.
No funding or relevant financial relationships were declared for this featured study.
FROM SABCS 2021