User login
News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
FDA to recommend limits on heavy metals in baby foods
The Food and Drug Administration has responded to congressional criticism and launched a multiyear plan to reduce the amount of heavy metals such as mercury and arsenic found in baby food.
Called “Closer to Zero,” the FDA plan calls for continued scientific investigation, establishes acceptable levels of heavy metals, sets up a way to monitor manufacturers’ compliance, and sets “action levels.”
“Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time,” the FDA said.
However, Closer to Zero will only make recommendations on heavy metal levels.
“Although action levels are not binding, we have seen that, over the years, our guidance on action levels and other actions have contributed to significant reductions of toxic elements in food,” an FDA spokeswoman wrote in a statement, according to the Washington Post.
A congressional panel said in February 2021 that major brands of commercial baby food routinely have high levels of toxic heavy metals. The House Oversight Committee said this leaves babies at risk for serious developmental and neurologic problems.
The committee sharply criticized the FDA for not taking action.
“Despite the well-known risks of harm to babies from toxic heavy metals, FDA has not taken adequate steps to decrease their presence in baby foods,” the committee said. “FDA has not issued thresholds for the vast majority of toxic heavy metals in baby foods and does not require warning labels on any baby food products.”
A version of this article first appeared on WebMD.com.
The Food and Drug Administration has responded to congressional criticism and launched a multiyear plan to reduce the amount of heavy metals such as mercury and arsenic found in baby food.
Called “Closer to Zero,” the FDA plan calls for continued scientific investigation, establishes acceptable levels of heavy metals, sets up a way to monitor manufacturers’ compliance, and sets “action levels.”
“Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time,” the FDA said.
However, Closer to Zero will only make recommendations on heavy metal levels.
“Although action levels are not binding, we have seen that, over the years, our guidance on action levels and other actions have contributed to significant reductions of toxic elements in food,” an FDA spokeswoman wrote in a statement, according to the Washington Post.
A congressional panel said in February 2021 that major brands of commercial baby food routinely have high levels of toxic heavy metals. The House Oversight Committee said this leaves babies at risk for serious developmental and neurologic problems.
The committee sharply criticized the FDA for not taking action.
“Despite the well-known risks of harm to babies from toxic heavy metals, FDA has not taken adequate steps to decrease their presence in baby foods,” the committee said. “FDA has not issued thresholds for the vast majority of toxic heavy metals in baby foods and does not require warning labels on any baby food products.”
A version of this article first appeared on WebMD.com.
The Food and Drug Administration has responded to congressional criticism and launched a multiyear plan to reduce the amount of heavy metals such as mercury and arsenic found in baby food.
Called “Closer to Zero,” the FDA plan calls for continued scientific investigation, establishes acceptable levels of heavy metals, sets up a way to monitor manufacturers’ compliance, and sets “action levels.”
“Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time,” the FDA said.
However, Closer to Zero will only make recommendations on heavy metal levels.
“Although action levels are not binding, we have seen that, over the years, our guidance on action levels and other actions have contributed to significant reductions of toxic elements in food,” an FDA spokeswoman wrote in a statement, according to the Washington Post.
A congressional panel said in February 2021 that major brands of commercial baby food routinely have high levels of toxic heavy metals. The House Oversight Committee said this leaves babies at risk for serious developmental and neurologic problems.
The committee sharply criticized the FDA for not taking action.
“Despite the well-known risks of harm to babies from toxic heavy metals, FDA has not taken adequate steps to decrease their presence in baby foods,” the committee said. “FDA has not issued thresholds for the vast majority of toxic heavy metals in baby foods and does not require warning labels on any baby food products.”
A version of this article first appeared on WebMD.com.
Low-calorie diet linked to improved chemo response in leukemia
Children and adolescents with leukemia who were placed on a restrictive diet and exercise regimen concurrent with starting chemotherapy showed responses to treatment that were better than those historically seen in such patients.
This apparently improved response suggests it is possible to boost treatment efficacy without raising the dose – or toxicity – of chemotherapy.
“To our knowledge, this is the first study in any hematologic malignancy to demonstrate potential benefit from caloric restriction via diet and exercise to augment chemotherapy efficacy and improve disease response, the authors reported.
The findings come from the IDEAL pilot trial, conducted in 40 young patients (mean age, 15 years; range, 10-21 years) diagnosed with high-risk B-cell acute lymphoblastic leukemia (B-ALL).
The study was published online April 1 in Blood Advances.
The diet and exercise regimen is a departure from current recommendations for patients with leukemia.
“This was a major paradigm shift – until now, many oncologists encouraged ‘comfort foods’ and increased calories to get through the rigor of chemotherapy,” first author Etan Orgel, MD, of Children’s Hospital Los Angeles and the University of Southern California, also in Los Angeles.
The results from this pilot trial suggest that “the era of encouraging comfort food should be in the past; over-nutrition is likely harmful, and diet and exercise are important tools to harness during chemotherapy,” he said.
Dr. Orgel added that childhood ALL was selected because it is the most common cancer of childhood, but the findings could have potential relevance in other cancer types in children as well as adults.
Commenting on the study, Patrick Brown, MD, director of the pediatric leukemia program at Johns Hopkins University, Baltimore, said the findings are important, albeit preliminary.
“I think the most important contribution of this pilot study is to show that it is possible to change the nutrition and exercise habits of children and adolescents during the initial month of treatment for ALL,” he said in an interview.
“We have to be cautious about the preliminary finding that these changes resulted in deeper remissions – this will need to be confirmed in a larger study,” added Dr. Brown, who was not involved with the research.
Dr. Orgel noted that a prospective, randomized trial, IDEAL-2, is launching later this year to further evaluate the intervention.
Obesity linked to poorer chemotherapy response
Among children and adolescents who start treatment for B-ALL, as many as 40% are overweight or obese, noted the study authors.
Those who are obese have more than a twofold greater risk of having persistent minimal residual disease (MRD) at the end of chemotherapy, considered the strongest patient-level predictor of poor outcome and a common guide for therapy intensification.
The problem is compounded by weight gain that is common during treatment as a result of prolonged chemotherapy and sedentary behavior, they commented.
With studies of obese mice linking calorie and fat restriction to improved survival after chemotherapy, the authors theorized that a calorie- and fat-restrictive diet and exercise could help improve outcomes after chemotherapy in humans.
Participants were enrolled at Children’s Hospital Los Angeles and City of Hope National Medical Center in nearby Duarte. After they were started on chemotherapy, they were placed on a low-carb, low-fat, and low-sugar diet tailored to patient needs and preferences, as well as a moderate daily exercise regimen, and continued on this regimen throughout the 4-week induction phase.
Following the intervention, there were no significant reductions observed in median gain of fat mass at the end of the intervention, compared with baseline (P = .13). However, in the subgroup of patients who were overweight or obese at baseline, the reduction in fat mass was indeed significant versus baseline (+1.5% vs. +9.7% at baseline; P = .02).
Importantly, after adjustment for prognostic factors, adherence to the intervention was associated with a significant reduction in the risk of MRD, compared with recent historical controls who received the same induction therapy at the same institution, but no intervention (odds ratio, 0.30; P = .02).
The intervention was also associated with a lower detectable MRD, compared with the historical controls (OR, 0.16; one-sided P = .002).
“Most importantly, the IDEAL intervention reduced risk of MRD at the end of induction in all patients, irrespective of starting [body mass index] and after accounting for prognostic features,” the authors noted.
Adherence to diet high, exercise low
As many as 82% of study participants achieved the goal of 20% or more caloric deficit throughout the chemotherapy.
“Adherence to the diet was excellent, with caloric deficits and macronutrient goals achieved in nearly all patients, including in the lean group,” the authors reported.
Dr. Orgel added that families embraced the chance to play an active role in the cancer therapy. “In our view, they couldn’t control their disease or their chemotherapy, but this, they could,” he said.
Conversely, adherence to the prescribed exercise was low – just 31.2%, with the inactivity during the first month likely contributed to the similar loss of muscle mass that occurred in both cohorts, Dr. Orgel noted.
“The [low exercise adherence] unfortunately was not a surprise, as it is often difficult to exercise and be active during chemotherapy,” he said.
Key aspects of physical activity will be refined in further studies, Dr. Orgel added.
Insulin sensitivity, adiponectin key factors?
Patients receiving the intervention showed improved insulin sensitivity and reductions in circulating insulin, which are notable in that insulin has been linked to mechanisms that counter chemoresistance, the authors noted.
Furthermore, the decreases in insulin were accompanied by notable elevations in circulating adiponectin, a protein hormone produced and secreted by fat cells.
“Adiponectin was certainly a surprise, as until now it did not appear to play a major role in cancer cell resistance to chemotherapy,” Dr. Orgel said.
“It is too soon to say they are central to the mechanism of the intervention, but the large differences in adiponectin and insulin sensitivity found in children in the trial have definitely highlighted these as important for future study,” he added.
Dr. Orgel, the study coauthors, and Dr. Brown disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children and adolescents with leukemia who were placed on a restrictive diet and exercise regimen concurrent with starting chemotherapy showed responses to treatment that were better than those historically seen in such patients.
This apparently improved response suggests it is possible to boost treatment efficacy without raising the dose – or toxicity – of chemotherapy.
“To our knowledge, this is the first study in any hematologic malignancy to demonstrate potential benefit from caloric restriction via diet and exercise to augment chemotherapy efficacy and improve disease response, the authors reported.
The findings come from the IDEAL pilot trial, conducted in 40 young patients (mean age, 15 years; range, 10-21 years) diagnosed with high-risk B-cell acute lymphoblastic leukemia (B-ALL).
The study was published online April 1 in Blood Advances.
The diet and exercise regimen is a departure from current recommendations for patients with leukemia.
“This was a major paradigm shift – until now, many oncologists encouraged ‘comfort foods’ and increased calories to get through the rigor of chemotherapy,” first author Etan Orgel, MD, of Children’s Hospital Los Angeles and the University of Southern California, also in Los Angeles.
The results from this pilot trial suggest that “the era of encouraging comfort food should be in the past; over-nutrition is likely harmful, and diet and exercise are important tools to harness during chemotherapy,” he said.
Dr. Orgel added that childhood ALL was selected because it is the most common cancer of childhood, but the findings could have potential relevance in other cancer types in children as well as adults.
Commenting on the study, Patrick Brown, MD, director of the pediatric leukemia program at Johns Hopkins University, Baltimore, said the findings are important, albeit preliminary.
“I think the most important contribution of this pilot study is to show that it is possible to change the nutrition and exercise habits of children and adolescents during the initial month of treatment for ALL,” he said in an interview.
“We have to be cautious about the preliminary finding that these changes resulted in deeper remissions – this will need to be confirmed in a larger study,” added Dr. Brown, who was not involved with the research.
Dr. Orgel noted that a prospective, randomized trial, IDEAL-2, is launching later this year to further evaluate the intervention.
Obesity linked to poorer chemotherapy response
Among children and adolescents who start treatment for B-ALL, as many as 40% are overweight or obese, noted the study authors.
Those who are obese have more than a twofold greater risk of having persistent minimal residual disease (MRD) at the end of chemotherapy, considered the strongest patient-level predictor of poor outcome and a common guide for therapy intensification.
The problem is compounded by weight gain that is common during treatment as a result of prolonged chemotherapy and sedentary behavior, they commented.
With studies of obese mice linking calorie and fat restriction to improved survival after chemotherapy, the authors theorized that a calorie- and fat-restrictive diet and exercise could help improve outcomes after chemotherapy in humans.
Participants were enrolled at Children’s Hospital Los Angeles and City of Hope National Medical Center in nearby Duarte. After they were started on chemotherapy, they were placed on a low-carb, low-fat, and low-sugar diet tailored to patient needs and preferences, as well as a moderate daily exercise regimen, and continued on this regimen throughout the 4-week induction phase.
Following the intervention, there were no significant reductions observed in median gain of fat mass at the end of the intervention, compared with baseline (P = .13). However, in the subgroup of patients who were overweight or obese at baseline, the reduction in fat mass was indeed significant versus baseline (+1.5% vs. +9.7% at baseline; P = .02).
Importantly, after adjustment for prognostic factors, adherence to the intervention was associated with a significant reduction in the risk of MRD, compared with recent historical controls who received the same induction therapy at the same institution, but no intervention (odds ratio, 0.30; P = .02).
The intervention was also associated with a lower detectable MRD, compared with the historical controls (OR, 0.16; one-sided P = .002).
“Most importantly, the IDEAL intervention reduced risk of MRD at the end of induction in all patients, irrespective of starting [body mass index] and after accounting for prognostic features,” the authors noted.
Adherence to diet high, exercise low
As many as 82% of study participants achieved the goal of 20% or more caloric deficit throughout the chemotherapy.
“Adherence to the diet was excellent, with caloric deficits and macronutrient goals achieved in nearly all patients, including in the lean group,” the authors reported.
Dr. Orgel added that families embraced the chance to play an active role in the cancer therapy. “In our view, they couldn’t control their disease or their chemotherapy, but this, they could,” he said.
Conversely, adherence to the prescribed exercise was low – just 31.2%, with the inactivity during the first month likely contributed to the similar loss of muscle mass that occurred in both cohorts, Dr. Orgel noted.
“The [low exercise adherence] unfortunately was not a surprise, as it is often difficult to exercise and be active during chemotherapy,” he said.
Key aspects of physical activity will be refined in further studies, Dr. Orgel added.
Insulin sensitivity, adiponectin key factors?
Patients receiving the intervention showed improved insulin sensitivity and reductions in circulating insulin, which are notable in that insulin has been linked to mechanisms that counter chemoresistance, the authors noted.
Furthermore, the decreases in insulin were accompanied by notable elevations in circulating adiponectin, a protein hormone produced and secreted by fat cells.
“Adiponectin was certainly a surprise, as until now it did not appear to play a major role in cancer cell resistance to chemotherapy,” Dr. Orgel said.
“It is too soon to say they are central to the mechanism of the intervention, but the large differences in adiponectin and insulin sensitivity found in children in the trial have definitely highlighted these as important for future study,” he added.
Dr. Orgel, the study coauthors, and Dr. Brown disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children and adolescents with leukemia who were placed on a restrictive diet and exercise regimen concurrent with starting chemotherapy showed responses to treatment that were better than those historically seen in such patients.
This apparently improved response suggests it is possible to boost treatment efficacy without raising the dose – or toxicity – of chemotherapy.
“To our knowledge, this is the first study in any hematologic malignancy to demonstrate potential benefit from caloric restriction via diet and exercise to augment chemotherapy efficacy and improve disease response, the authors reported.
The findings come from the IDEAL pilot trial, conducted in 40 young patients (mean age, 15 years; range, 10-21 years) diagnosed with high-risk B-cell acute lymphoblastic leukemia (B-ALL).
The study was published online April 1 in Blood Advances.
The diet and exercise regimen is a departure from current recommendations for patients with leukemia.
“This was a major paradigm shift – until now, many oncologists encouraged ‘comfort foods’ and increased calories to get through the rigor of chemotherapy,” first author Etan Orgel, MD, of Children’s Hospital Los Angeles and the University of Southern California, also in Los Angeles.
The results from this pilot trial suggest that “the era of encouraging comfort food should be in the past; over-nutrition is likely harmful, and diet and exercise are important tools to harness during chemotherapy,” he said.
Dr. Orgel added that childhood ALL was selected because it is the most common cancer of childhood, but the findings could have potential relevance in other cancer types in children as well as adults.
Commenting on the study, Patrick Brown, MD, director of the pediatric leukemia program at Johns Hopkins University, Baltimore, said the findings are important, albeit preliminary.
“I think the most important contribution of this pilot study is to show that it is possible to change the nutrition and exercise habits of children and adolescents during the initial month of treatment for ALL,” he said in an interview.
“We have to be cautious about the preliminary finding that these changes resulted in deeper remissions – this will need to be confirmed in a larger study,” added Dr. Brown, who was not involved with the research.
Dr. Orgel noted that a prospective, randomized trial, IDEAL-2, is launching later this year to further evaluate the intervention.
Obesity linked to poorer chemotherapy response
Among children and adolescents who start treatment for B-ALL, as many as 40% are overweight or obese, noted the study authors.
Those who are obese have more than a twofold greater risk of having persistent minimal residual disease (MRD) at the end of chemotherapy, considered the strongest patient-level predictor of poor outcome and a common guide for therapy intensification.
The problem is compounded by weight gain that is common during treatment as a result of prolonged chemotherapy and sedentary behavior, they commented.
With studies of obese mice linking calorie and fat restriction to improved survival after chemotherapy, the authors theorized that a calorie- and fat-restrictive diet and exercise could help improve outcomes after chemotherapy in humans.
Participants were enrolled at Children’s Hospital Los Angeles and City of Hope National Medical Center in nearby Duarte. After they were started on chemotherapy, they were placed on a low-carb, low-fat, and low-sugar diet tailored to patient needs and preferences, as well as a moderate daily exercise regimen, and continued on this regimen throughout the 4-week induction phase.
Following the intervention, there were no significant reductions observed in median gain of fat mass at the end of the intervention, compared with baseline (P = .13). However, in the subgroup of patients who were overweight or obese at baseline, the reduction in fat mass was indeed significant versus baseline (+1.5% vs. +9.7% at baseline; P = .02).
Importantly, after adjustment for prognostic factors, adherence to the intervention was associated with a significant reduction in the risk of MRD, compared with recent historical controls who received the same induction therapy at the same institution, but no intervention (odds ratio, 0.30; P = .02).
The intervention was also associated with a lower detectable MRD, compared with the historical controls (OR, 0.16; one-sided P = .002).
“Most importantly, the IDEAL intervention reduced risk of MRD at the end of induction in all patients, irrespective of starting [body mass index] and after accounting for prognostic features,” the authors noted.
Adherence to diet high, exercise low
As many as 82% of study participants achieved the goal of 20% or more caloric deficit throughout the chemotherapy.
“Adherence to the diet was excellent, with caloric deficits and macronutrient goals achieved in nearly all patients, including in the lean group,” the authors reported.
Dr. Orgel added that families embraced the chance to play an active role in the cancer therapy. “In our view, they couldn’t control their disease or their chemotherapy, but this, they could,” he said.
Conversely, adherence to the prescribed exercise was low – just 31.2%, with the inactivity during the first month likely contributed to the similar loss of muscle mass that occurred in both cohorts, Dr. Orgel noted.
“The [low exercise adherence] unfortunately was not a surprise, as it is often difficult to exercise and be active during chemotherapy,” he said.
Key aspects of physical activity will be refined in further studies, Dr. Orgel added.
Insulin sensitivity, adiponectin key factors?
Patients receiving the intervention showed improved insulin sensitivity and reductions in circulating insulin, which are notable in that insulin has been linked to mechanisms that counter chemoresistance, the authors noted.
Furthermore, the decreases in insulin were accompanied by notable elevations in circulating adiponectin, a protein hormone produced and secreted by fat cells.
“Adiponectin was certainly a surprise, as until now it did not appear to play a major role in cancer cell resistance to chemotherapy,” Dr. Orgel said.
“It is too soon to say they are central to the mechanism of the intervention, but the large differences in adiponectin and insulin sensitivity found in children in the trial have definitely highlighted these as important for future study,” he added.
Dr. Orgel, the study coauthors, and Dr. Brown disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 in children: New cases on the rise again
The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.
The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.
State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.
Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.
The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.
The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.
State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.
Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.
The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.
The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.
State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.
Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.
The obesity risk everyone forgets
Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?
Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.
Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.
I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
Pathways to obesity
Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.
As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.
I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.
But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
Shifting our approach to treatment
The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.
Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.
To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.
A version of this article first appeared on Medscape.com.
Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?
Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.
Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.
I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
Pathways to obesity
Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.
As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.
I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.
But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
Shifting our approach to treatment
The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.
Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.
To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.
A version of this article first appeared on Medscape.com.
Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?
Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.
Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.
I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
Pathways to obesity
Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.
As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.
I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.
But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
Shifting our approach to treatment
The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.
Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.
To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.
A version of this article first appeared on Medscape.com.
Helping your patients navigate the coming out process
“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.
Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.
One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.
The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.
So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.1 This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.2 Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.
In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.
Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at pdnews@mdedge.com.
References
1. Human Rights Campaign 2018 LGBTQ Youth Report.
2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.
“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.
Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.
One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.
The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.
So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.1 This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.2 Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.
In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.
Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at pdnews@mdedge.com.
References
1. Human Rights Campaign 2018 LGBTQ Youth Report.
2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.
“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.
Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.
One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.
The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.
So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.1 This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.2 Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.
In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.
Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at pdnews@mdedge.com.
References
1. Human Rights Campaign 2018 LGBTQ Youth Report.
2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.
Family psychoeducation is critical in care of children with disabilities
Dr. Margaret G. Klitzke is a board-certified child and adolescent psychiatrist who has worked across all settings of the Center for Autism and Developmental Disabilities at Bradley Hospital in East Providence, R.I.
I spoke with Dr. Klitzke recently about her work as an outpatient psychiatrist at the center and about the important role of families in the treatment it provides. The center offers highly specialized clinical services for children and adolescents between the ages of 2 and 18 who show signs of serious emotional and behavioral problems in addition to a developmental disability, such as autism, Asperger’s, or intellectual disability.
The center’s model of care emphasizes family involvement. Dr. Klitzke was trained in family interventions by Nathan B. Epstein, MD, and Duane S. Bishop, MD, the originators of the McMaster approach and the problem-centered systems therapy of the family. This training informs much of her work with families.
ALISON M. HERU, MD: Hello, Dr. Klitzke and thank you for agreeing to this interview.
MARGARET G. KLITZKE, DO: My pleasure.
AMH: I admire your dedication to this population of children and adolescents. To me, it seems very hard to work with patients and families where there is significant disability and there is little hope of the patient “getting better.”
MGK: When parents come to us, they have great hopes their children can be helped. They often express understanding and acceptance of the child’s disability, and seek to understand the psychiatric or behavioral issues. These parents are often very dedicated to their children, giving up careers to care for them. But as professionals, we must be sensitive to the role each parent can play and how they can support each other and the family.
AMH: So much of your work focuses on family inclusion and family psychoeducation?
MGK: Yes. An example that stands out is a couple where the mother had become the voice for the family in dealing with professionals, but she was overwhelmed in this role. So, we invited the father in. He explained that medical professionals and school personnel would address their remarks to his wife and that he felt marginalized. We worked with the couple, now always including the father, and he has gone on to become a vocal advocate for children with disabilities. It is inspiring to watch families become advocates – to insist that others see the child’s strengths – not just weaknesses.
AMH: Do you feel that the families ever come to you with too high expectations of what you can do to help their child?
MGK: As a child psychiatrist, one must put oneself in the parents’ shoes. Charlie Zeanah Jr., MD, and others have done wonderful work in attachment. They have identified that parents have fantasies and beliefs about what the child will be like before the child is born. We all have fantasies about our babies before they come to us! For many families, they quickly come to understand that their child is not like other children. This new world of parenting is not what they expected. A mother once gave me a short piece called “Welcome to Holland,” written by a mother whose child has Down syndrome.
AMH: How do you begin to work with these families? There must be such a sense of loss and tragedy in their lives.
MGK: My first goal is to understand what it is like to have a child with developmental disability, not just for the parents but for the siblings, too. I strive to understand what the parents want for their child and how they see themselves as a family. I see us, the health care team, as agents to help the child and the family be the very best they can be.
AMH: How do you deal with parents who are not be on the same page?
MGK: It is important that parents are consistent and are able to work together. Even if they are divorced, I have seen families able to unite around the care of their child with a disability. This is quite an achievement given the high rates of divorce – although most of the families that I have worked with are intact. As in all families, each member has a role in helping the family function well. It means using the strength of each parent to help them become a parenting team.
AMH: What if the parents have unrealistic expectations of their child?
MGK: Yes, there are parents who come to us with unrealistic expectations, such as believing their nonverbal child will talk some day. In such a case, we must be certain that we have exhausted all methods to help this child communicate, and once we have done all we can, then we must accept where that child is; to accept and help the family accept, the child’s weaknesses and acknowledge their strengths. Change what you can and be a support for everything else.
AMH: I find it hard to imagine caring for a severely disabled child. How do these parents do this?
MGK: These are children who are nonverbal, and children who can be very fragile, even medically. What I see are parents who want to connect, who want to find that something inside that child, that special place where there is connection. That place of reciprocity. That is important to us all, helping the family find that place of reciprocal connection.
AMH: What language do you use to discuss this with families?
MGK: I say, “This is the child’s strength and this is the child’s weakness; capitalize on the strengths and let’s shore up their weaknesses.”
AMH: How do you approach the families? Where do you start?
MGK: I meet the family where they are. One cannot with these families or any families stand rigidly 10 feet away, and demand that they change. This never works, and we will be of no help to them. We must understand the family system and how they have arrived at their current place of functioning.
AMH: Can you give an example?
MGK: Yes, for example if a parent is drinking excessively, I help them understand why they are coping that way and see if they are willing to change.
AMH: What keeps you going ?
MGK: I think it comes back to the family work. For me, I believe the families are doing the very best they can. If the family is really impaired in some way, I see it as my job to figure out why that is their pattern of behavior, and I do what I can to help them facilitate change.
AMH: What inspires you about these families?
MGK: These families are able to recognize the strengths and beauty that their children bring them – the strength of these children, their personalities and their wills of steel! They are able to communicate what they need. Siblings, too, make life decisions based on their experiences. They often end up going down the path of caring for such children as professionals.
AMH: Do you have any recommendations for a young child psychiatrist who might be considering working with this population?
MGK: Developmental disabilities in child psychiatry is where medicine, neurology, and child development meet. The advances in genetics and neurology are major gifts to the field. It used to be that I would have to sell the field to medical students and residents. Now they are coming to me saying that they want to work in this area. It is an intellectually rich field in which to work. There is a real change happening. But the place where it becomes really magical is in working with the families.
AMH: What other changes have you seen?
MGK: With the closure of big institutions, it is less of an option for families to walk away. The families now feel that they need to take care of the child.
AMH: What has your career taught you?
MGK: It has taught me patience, to enter every situation without preconceived notions, and that there is something new to learn every day.
References
J Child Adolesc Psychiatry. 1975 Jun 1;14(3):387-421.
Evaluation and Treating Families: The McMaster Approach. Routledge/Taylor & Francis Group, 2005.
Movies to watch
Lorenzo’s Oil, 1992.
My Left Foot, 1989.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (Routledge, 2013). She has no conflicts of interest.
Dr. Klitkze is a 1983 graduate of the Texas College of Osteopathic Medicine, and completed her residency and fellowship training at Brown University, Providence, R.I. She is a member of the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry, and the Rhode Island Medical Society, where she serves on the Physicians’ Health Committee. She is actively involved in teaching medical students, residents, and fellows, and has received several teaching awards from the department of psychiatry and human behavior at Brown.
Dr. Margaret G. Klitzke is a board-certified child and adolescent psychiatrist who has worked across all settings of the Center for Autism and Developmental Disabilities at Bradley Hospital in East Providence, R.I.
I spoke with Dr. Klitzke recently about her work as an outpatient psychiatrist at the center and about the important role of families in the treatment it provides. The center offers highly specialized clinical services for children and adolescents between the ages of 2 and 18 who show signs of serious emotional and behavioral problems in addition to a developmental disability, such as autism, Asperger’s, or intellectual disability.
The center’s model of care emphasizes family involvement. Dr. Klitzke was trained in family interventions by Nathan B. Epstein, MD, and Duane S. Bishop, MD, the originators of the McMaster approach and the problem-centered systems therapy of the family. This training informs much of her work with families.
ALISON M. HERU, MD: Hello, Dr. Klitzke and thank you for agreeing to this interview.
MARGARET G. KLITZKE, DO: My pleasure.
AMH: I admire your dedication to this population of children and adolescents. To me, it seems very hard to work with patients and families where there is significant disability and there is little hope of the patient “getting better.”
MGK: When parents come to us, they have great hopes their children can be helped. They often express understanding and acceptance of the child’s disability, and seek to understand the psychiatric or behavioral issues. These parents are often very dedicated to their children, giving up careers to care for them. But as professionals, we must be sensitive to the role each parent can play and how they can support each other and the family.
AMH: So much of your work focuses on family inclusion and family psychoeducation?
MGK: Yes. An example that stands out is a couple where the mother had become the voice for the family in dealing with professionals, but she was overwhelmed in this role. So, we invited the father in. He explained that medical professionals and school personnel would address their remarks to his wife and that he felt marginalized. We worked with the couple, now always including the father, and he has gone on to become a vocal advocate for children with disabilities. It is inspiring to watch families become advocates – to insist that others see the child’s strengths – not just weaknesses.
AMH: Do you feel that the families ever come to you with too high expectations of what you can do to help their child?
MGK: As a child psychiatrist, one must put oneself in the parents’ shoes. Charlie Zeanah Jr., MD, and others have done wonderful work in attachment. They have identified that parents have fantasies and beliefs about what the child will be like before the child is born. We all have fantasies about our babies before they come to us! For many families, they quickly come to understand that their child is not like other children. This new world of parenting is not what they expected. A mother once gave me a short piece called “Welcome to Holland,” written by a mother whose child has Down syndrome.
AMH: How do you begin to work with these families? There must be such a sense of loss and tragedy in their lives.
MGK: My first goal is to understand what it is like to have a child with developmental disability, not just for the parents but for the siblings, too. I strive to understand what the parents want for their child and how they see themselves as a family. I see us, the health care team, as agents to help the child and the family be the very best they can be.
AMH: How do you deal with parents who are not be on the same page?
MGK: It is important that parents are consistent and are able to work together. Even if they are divorced, I have seen families able to unite around the care of their child with a disability. This is quite an achievement given the high rates of divorce – although most of the families that I have worked with are intact. As in all families, each member has a role in helping the family function well. It means using the strength of each parent to help them become a parenting team.
AMH: What if the parents have unrealistic expectations of their child?
MGK: Yes, there are parents who come to us with unrealistic expectations, such as believing their nonverbal child will talk some day. In such a case, we must be certain that we have exhausted all methods to help this child communicate, and once we have done all we can, then we must accept where that child is; to accept and help the family accept, the child’s weaknesses and acknowledge their strengths. Change what you can and be a support for everything else.
AMH: I find it hard to imagine caring for a severely disabled child. How do these parents do this?
MGK: These are children who are nonverbal, and children who can be very fragile, even medically. What I see are parents who want to connect, who want to find that something inside that child, that special place where there is connection. That place of reciprocity. That is important to us all, helping the family find that place of reciprocal connection.
AMH: What language do you use to discuss this with families?
MGK: I say, “This is the child’s strength and this is the child’s weakness; capitalize on the strengths and let’s shore up their weaknesses.”
AMH: How do you approach the families? Where do you start?
MGK: I meet the family where they are. One cannot with these families or any families stand rigidly 10 feet away, and demand that they change. This never works, and we will be of no help to them. We must understand the family system and how they have arrived at their current place of functioning.
AMH: Can you give an example?
MGK: Yes, for example if a parent is drinking excessively, I help them understand why they are coping that way and see if they are willing to change.
AMH: What keeps you going ?
MGK: I think it comes back to the family work. For me, I believe the families are doing the very best they can. If the family is really impaired in some way, I see it as my job to figure out why that is their pattern of behavior, and I do what I can to help them facilitate change.
AMH: What inspires you about these families?
MGK: These families are able to recognize the strengths and beauty that their children bring them – the strength of these children, their personalities and their wills of steel! They are able to communicate what they need. Siblings, too, make life decisions based on their experiences. They often end up going down the path of caring for such children as professionals.
AMH: Do you have any recommendations for a young child psychiatrist who might be considering working with this population?
MGK: Developmental disabilities in child psychiatry is where medicine, neurology, and child development meet. The advances in genetics and neurology are major gifts to the field. It used to be that I would have to sell the field to medical students and residents. Now they are coming to me saying that they want to work in this area. It is an intellectually rich field in which to work. There is a real change happening. But the place where it becomes really magical is in working with the families.
AMH: What other changes have you seen?
MGK: With the closure of big institutions, it is less of an option for families to walk away. The families now feel that they need to take care of the child.
AMH: What has your career taught you?
MGK: It has taught me patience, to enter every situation without preconceived notions, and that there is something new to learn every day.
References
J Child Adolesc Psychiatry. 1975 Jun 1;14(3):387-421.
Evaluation and Treating Families: The McMaster Approach. Routledge/Taylor & Francis Group, 2005.
Movies to watch
Lorenzo’s Oil, 1992.
My Left Foot, 1989.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (Routledge, 2013). She has no conflicts of interest.
Dr. Klitkze is a 1983 graduate of the Texas College of Osteopathic Medicine, and completed her residency and fellowship training at Brown University, Providence, R.I. She is a member of the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry, and the Rhode Island Medical Society, where she serves on the Physicians’ Health Committee. She is actively involved in teaching medical students, residents, and fellows, and has received several teaching awards from the department of psychiatry and human behavior at Brown.
Dr. Margaret G. Klitzke is a board-certified child and adolescent psychiatrist who has worked across all settings of the Center for Autism and Developmental Disabilities at Bradley Hospital in East Providence, R.I.
I spoke with Dr. Klitzke recently about her work as an outpatient psychiatrist at the center and about the important role of families in the treatment it provides. The center offers highly specialized clinical services for children and adolescents between the ages of 2 and 18 who show signs of serious emotional and behavioral problems in addition to a developmental disability, such as autism, Asperger’s, or intellectual disability.
The center’s model of care emphasizes family involvement. Dr. Klitzke was trained in family interventions by Nathan B. Epstein, MD, and Duane S. Bishop, MD, the originators of the McMaster approach and the problem-centered systems therapy of the family. This training informs much of her work with families.
ALISON M. HERU, MD: Hello, Dr. Klitzke and thank you for agreeing to this interview.
MARGARET G. KLITZKE, DO: My pleasure.
AMH: I admire your dedication to this population of children and adolescents. To me, it seems very hard to work with patients and families where there is significant disability and there is little hope of the patient “getting better.”
MGK: When parents come to us, they have great hopes their children can be helped. They often express understanding and acceptance of the child’s disability, and seek to understand the psychiatric or behavioral issues. These parents are often very dedicated to their children, giving up careers to care for them. But as professionals, we must be sensitive to the role each parent can play and how they can support each other and the family.
AMH: So much of your work focuses on family inclusion and family psychoeducation?
MGK: Yes. An example that stands out is a couple where the mother had become the voice for the family in dealing with professionals, but she was overwhelmed in this role. So, we invited the father in. He explained that medical professionals and school personnel would address their remarks to his wife and that he felt marginalized. We worked with the couple, now always including the father, and he has gone on to become a vocal advocate for children with disabilities. It is inspiring to watch families become advocates – to insist that others see the child’s strengths – not just weaknesses.
AMH: Do you feel that the families ever come to you with too high expectations of what you can do to help their child?
MGK: As a child psychiatrist, one must put oneself in the parents’ shoes. Charlie Zeanah Jr., MD, and others have done wonderful work in attachment. They have identified that parents have fantasies and beliefs about what the child will be like before the child is born. We all have fantasies about our babies before they come to us! For many families, they quickly come to understand that their child is not like other children. This new world of parenting is not what they expected. A mother once gave me a short piece called “Welcome to Holland,” written by a mother whose child has Down syndrome.
AMH: How do you begin to work with these families? There must be such a sense of loss and tragedy in their lives.
MGK: My first goal is to understand what it is like to have a child with developmental disability, not just for the parents but for the siblings, too. I strive to understand what the parents want for their child and how they see themselves as a family. I see us, the health care team, as agents to help the child and the family be the very best they can be.
AMH: How do you deal with parents who are not be on the same page?
MGK: It is important that parents are consistent and are able to work together. Even if they are divorced, I have seen families able to unite around the care of their child with a disability. This is quite an achievement given the high rates of divorce – although most of the families that I have worked with are intact. As in all families, each member has a role in helping the family function well. It means using the strength of each parent to help them become a parenting team.
AMH: What if the parents have unrealistic expectations of their child?
MGK: Yes, there are parents who come to us with unrealistic expectations, such as believing their nonverbal child will talk some day. In such a case, we must be certain that we have exhausted all methods to help this child communicate, and once we have done all we can, then we must accept where that child is; to accept and help the family accept, the child’s weaknesses and acknowledge their strengths. Change what you can and be a support for everything else.
AMH: I find it hard to imagine caring for a severely disabled child. How do these parents do this?
MGK: These are children who are nonverbal, and children who can be very fragile, even medically. What I see are parents who want to connect, who want to find that something inside that child, that special place where there is connection. That place of reciprocity. That is important to us all, helping the family find that place of reciprocal connection.
AMH: What language do you use to discuss this with families?
MGK: I say, “This is the child’s strength and this is the child’s weakness; capitalize on the strengths and let’s shore up their weaknesses.”
AMH: How do you approach the families? Where do you start?
MGK: I meet the family where they are. One cannot with these families or any families stand rigidly 10 feet away, and demand that they change. This never works, and we will be of no help to them. We must understand the family system and how they have arrived at their current place of functioning.
AMH: Can you give an example?
MGK: Yes, for example if a parent is drinking excessively, I help them understand why they are coping that way and see if they are willing to change.
AMH: What keeps you going ?
MGK: I think it comes back to the family work. For me, I believe the families are doing the very best they can. If the family is really impaired in some way, I see it as my job to figure out why that is their pattern of behavior, and I do what I can to help them facilitate change.
AMH: What inspires you about these families?
MGK: These families are able to recognize the strengths and beauty that their children bring them – the strength of these children, their personalities and their wills of steel! They are able to communicate what they need. Siblings, too, make life decisions based on their experiences. They often end up going down the path of caring for such children as professionals.
AMH: Do you have any recommendations for a young child psychiatrist who might be considering working with this population?
MGK: Developmental disabilities in child psychiatry is where medicine, neurology, and child development meet. The advances in genetics and neurology are major gifts to the field. It used to be that I would have to sell the field to medical students and residents. Now they are coming to me saying that they want to work in this area. It is an intellectually rich field in which to work. There is a real change happening. But the place where it becomes really magical is in working with the families.
AMH: What other changes have you seen?
MGK: With the closure of big institutions, it is less of an option for families to walk away. The families now feel that they need to take care of the child.
AMH: What has your career taught you?
MGK: It has taught me patience, to enter every situation without preconceived notions, and that there is something new to learn every day.
References
J Child Adolesc Psychiatry. 1975 Jun 1;14(3):387-421.
Evaluation and Treating Families: The McMaster Approach. Routledge/Taylor & Francis Group, 2005.
Movies to watch
Lorenzo’s Oil, 1992.
My Left Foot, 1989.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (Routledge, 2013). She has no conflicts of interest.
Dr. Klitkze is a 1983 graduate of the Texas College of Osteopathic Medicine, and completed her residency and fellowship training at Brown University, Providence, R.I. She is a member of the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry, and the Rhode Island Medical Society, where she serves on the Physicians’ Health Committee. She is actively involved in teaching medical students, residents, and fellows, and has received several teaching awards from the department of psychiatry and human behavior at Brown.
Next winter may be rough: Models predict ‘considerable surge’ of COVID
It’s likely the United States will see another surge of COVID-19 this winter, warned Christopher Murray, MD, director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.
Speaking at the national conference of State of Reform on April 8, Dr. Murray cited the seasonality of the SARS-CoV-2 virus, which wanes in the summer and waxes in the winter. The “optimistic forecast” of IHME, which has modeled the course of the pandemic for the past 13 months, is that daily deaths will rise a bit in the next month, then decline from May through August, he said.
“Summer should be fairly quiet in terms of COVID, if vaccinations rise and people don’t stop wearing masks,” Dr. Murray said.
But he added that “a considerable surge will occur over next winter,” because the new variants are more transmissible, and people will likely relax social distancing and mask wearing. The IHME predicts that the percentage of Americans who usually don masks will decline from 73% today to 21% by Aug. 1.
With a rapid decline in mask use and a rise in mobility, there will still be more than 1,000 deaths each day by July 1, Dr. Murray said. In a forecast released the day after Dr. Murray spoke, the IHME predicted that by Aug. 1, there will be a total of 618,523 U.S. deaths from COVID-19. Deaths could be as high as 696,651 if mobility among the vaccinated returns to prepandemic levels, the institute forecasts.
Based on cell phone data, Dr. Murray said, the amount of mobility in the United States has already risen to the level of March 2020, when the pandemic was just getting underway.
Decreased infections
If there’s one piece of good news in the latest IHME report, it’s that the estimated number of people infected (including those not tested) will drop from 111,581 today to a projected 17,502 on Aug. 1. But in a worst-case scenario, with sharply higher mobility among vaccinated people, the case count on that date would only fall to 73,842.
The SARS-CoV-2 variants are another factor of concern. Dr. Murray distinguished between variants like the one first identified in the U.K. (B.1.1.7) and other “escape variants.”
B.1.1.7, which is now the dominant strain in the United States, increases transmission but doesn’t necessarily escape the immune system or vaccines, he explained.
In contrast, if someone is infected with a variant such as the South African or the Brazilian mutations, he said, a previous COVID-19 infection might not protect the person, and vaccines are less effective against those variants.
Cross-variant immunity may range from 0% to 60% for escape variants, based on the slim amount of data now available, Dr. Murray said. In his view, these variants will be the long-term driver of the pandemic in the United States, while the United Kingdom variant is the short-term driver.
The latest data, he said, show that the Pfizer/BioNTech and Moderna vaccines are 75% effective against the escape variants, with lower efficacy for other vaccines. But booster shots may still be required to protect people against some variants.
Human factors
Human behavior will also help determine the course of the pandemic, he noted. Vaccine hesitancy, for example, is still high in the United States.
By the end of May, he predicted, about 180 million people will have received about two doses of vaccine. After that, he said, “vaccination will flatline due to lack of demand.” The two unknowns are how much campaigns to promote vaccination will increase vaccine confidence, and when children will be vaccinated.
In the United States, he said, 69% of adults have been vaccinated or want to get a shot. But that percentage has dropped 5 points since February, and vaccine confidence varies by state.
Dr. Murray emphasized that the winter surge he predicts can be blocked if people change their behaviors. These include a rise in vaccine confidence to 80% and continued mask wearing by most people.
However, if vaccine confidence and mask wearing decline, state governments continue to drop social distancing rules, and the uptake of boosters is low, the winter surge could be more serious, he said.
Double surge
Murray also raised the possibility of a double surge of COVID-19 and influenza this winter. Widely expected last winter, this double surge never materialized here or elsewhere, partly because of mask wearing. But Dr. Murray said it could happen this year: History shows that the flu tends to be stronger in years after weak outbreaks.
He advised hospitals to prepare now for whatever might come later this year. Public health authorities, he said, should speed up vaccination, monitor variants closely with additional sequencing, and try to modify behavior in high-risk groups.
Asked to explain the recent surge of COVID-19 cases in Michigan, Dr. Murray attributed it partly to the spread of the B.1.1.7 (U.K.) variant. But he noted that the U.K. variant has expanded even more widely in some other states that haven’t had an explosive surge like Michigan’s.
Moreover, he noted, Michigan doesn’t have low mask use or high mobility. So the upward spiral of COVID-19 infections there is very concerning, he said.
In regard to the role of children as reservoirs of the virus, Dr. Murray pointed out that views on this have changed around the world. For a while, people thought kids didn’t spread COVID-19 very much. That view shifted when U.K. data showed that child transmission of the B.1.1.7 variant increased by half to 9% of contacts in comparison with the original virus strain.
Dutch data, similarly, showed schools contributing to the latest outbreaks, and some European nations have closed schools. In the United States, the trend is to open them.
A version of this article first appeared on Medscape.com.
It’s likely the United States will see another surge of COVID-19 this winter, warned Christopher Murray, MD, director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.
Speaking at the national conference of State of Reform on April 8, Dr. Murray cited the seasonality of the SARS-CoV-2 virus, which wanes in the summer and waxes in the winter. The “optimistic forecast” of IHME, which has modeled the course of the pandemic for the past 13 months, is that daily deaths will rise a bit in the next month, then decline from May through August, he said.
“Summer should be fairly quiet in terms of COVID, if vaccinations rise and people don’t stop wearing masks,” Dr. Murray said.
But he added that “a considerable surge will occur over next winter,” because the new variants are more transmissible, and people will likely relax social distancing and mask wearing. The IHME predicts that the percentage of Americans who usually don masks will decline from 73% today to 21% by Aug. 1.
With a rapid decline in mask use and a rise in mobility, there will still be more than 1,000 deaths each day by July 1, Dr. Murray said. In a forecast released the day after Dr. Murray spoke, the IHME predicted that by Aug. 1, there will be a total of 618,523 U.S. deaths from COVID-19. Deaths could be as high as 696,651 if mobility among the vaccinated returns to prepandemic levels, the institute forecasts.
Based on cell phone data, Dr. Murray said, the amount of mobility in the United States has already risen to the level of March 2020, when the pandemic was just getting underway.
Decreased infections
If there’s one piece of good news in the latest IHME report, it’s that the estimated number of people infected (including those not tested) will drop from 111,581 today to a projected 17,502 on Aug. 1. But in a worst-case scenario, with sharply higher mobility among vaccinated people, the case count on that date would only fall to 73,842.
The SARS-CoV-2 variants are another factor of concern. Dr. Murray distinguished between variants like the one first identified in the U.K. (B.1.1.7) and other “escape variants.”
B.1.1.7, which is now the dominant strain in the United States, increases transmission but doesn’t necessarily escape the immune system or vaccines, he explained.
In contrast, if someone is infected with a variant such as the South African or the Brazilian mutations, he said, a previous COVID-19 infection might not protect the person, and vaccines are less effective against those variants.
Cross-variant immunity may range from 0% to 60% for escape variants, based on the slim amount of data now available, Dr. Murray said. In his view, these variants will be the long-term driver of the pandemic in the United States, while the United Kingdom variant is the short-term driver.
The latest data, he said, show that the Pfizer/BioNTech and Moderna vaccines are 75% effective against the escape variants, with lower efficacy for other vaccines. But booster shots may still be required to protect people against some variants.
Human factors
Human behavior will also help determine the course of the pandemic, he noted. Vaccine hesitancy, for example, is still high in the United States.
By the end of May, he predicted, about 180 million people will have received about two doses of vaccine. After that, he said, “vaccination will flatline due to lack of demand.” The two unknowns are how much campaigns to promote vaccination will increase vaccine confidence, and when children will be vaccinated.
In the United States, he said, 69% of adults have been vaccinated or want to get a shot. But that percentage has dropped 5 points since February, and vaccine confidence varies by state.
Dr. Murray emphasized that the winter surge he predicts can be blocked if people change their behaviors. These include a rise in vaccine confidence to 80% and continued mask wearing by most people.
However, if vaccine confidence and mask wearing decline, state governments continue to drop social distancing rules, and the uptake of boosters is low, the winter surge could be more serious, he said.
Double surge
Murray also raised the possibility of a double surge of COVID-19 and influenza this winter. Widely expected last winter, this double surge never materialized here or elsewhere, partly because of mask wearing. But Dr. Murray said it could happen this year: History shows that the flu tends to be stronger in years after weak outbreaks.
He advised hospitals to prepare now for whatever might come later this year. Public health authorities, he said, should speed up vaccination, monitor variants closely with additional sequencing, and try to modify behavior in high-risk groups.
Asked to explain the recent surge of COVID-19 cases in Michigan, Dr. Murray attributed it partly to the spread of the B.1.1.7 (U.K.) variant. But he noted that the U.K. variant has expanded even more widely in some other states that haven’t had an explosive surge like Michigan’s.
Moreover, he noted, Michigan doesn’t have low mask use or high mobility. So the upward spiral of COVID-19 infections there is very concerning, he said.
In regard to the role of children as reservoirs of the virus, Dr. Murray pointed out that views on this have changed around the world. For a while, people thought kids didn’t spread COVID-19 very much. That view shifted when U.K. data showed that child transmission of the B.1.1.7 variant increased by half to 9% of contacts in comparison with the original virus strain.
Dutch data, similarly, showed schools contributing to the latest outbreaks, and some European nations have closed schools. In the United States, the trend is to open them.
A version of this article first appeared on Medscape.com.
It’s likely the United States will see another surge of COVID-19 this winter, warned Christopher Murray, MD, director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.
Speaking at the national conference of State of Reform on April 8, Dr. Murray cited the seasonality of the SARS-CoV-2 virus, which wanes in the summer and waxes in the winter. The “optimistic forecast” of IHME, which has modeled the course of the pandemic for the past 13 months, is that daily deaths will rise a bit in the next month, then decline from May through August, he said.
“Summer should be fairly quiet in terms of COVID, if vaccinations rise and people don’t stop wearing masks,” Dr. Murray said.
But he added that “a considerable surge will occur over next winter,” because the new variants are more transmissible, and people will likely relax social distancing and mask wearing. The IHME predicts that the percentage of Americans who usually don masks will decline from 73% today to 21% by Aug. 1.
With a rapid decline in mask use and a rise in mobility, there will still be more than 1,000 deaths each day by July 1, Dr. Murray said. In a forecast released the day after Dr. Murray spoke, the IHME predicted that by Aug. 1, there will be a total of 618,523 U.S. deaths from COVID-19. Deaths could be as high as 696,651 if mobility among the vaccinated returns to prepandemic levels, the institute forecasts.
Based on cell phone data, Dr. Murray said, the amount of mobility in the United States has already risen to the level of March 2020, when the pandemic was just getting underway.
Decreased infections
If there’s one piece of good news in the latest IHME report, it’s that the estimated number of people infected (including those not tested) will drop from 111,581 today to a projected 17,502 on Aug. 1. But in a worst-case scenario, with sharply higher mobility among vaccinated people, the case count on that date would only fall to 73,842.
The SARS-CoV-2 variants are another factor of concern. Dr. Murray distinguished between variants like the one first identified in the U.K. (B.1.1.7) and other “escape variants.”
B.1.1.7, which is now the dominant strain in the United States, increases transmission but doesn’t necessarily escape the immune system or vaccines, he explained.
In contrast, if someone is infected with a variant such as the South African or the Brazilian mutations, he said, a previous COVID-19 infection might not protect the person, and vaccines are less effective against those variants.
Cross-variant immunity may range from 0% to 60% for escape variants, based on the slim amount of data now available, Dr. Murray said. In his view, these variants will be the long-term driver of the pandemic in the United States, while the United Kingdom variant is the short-term driver.
The latest data, he said, show that the Pfizer/BioNTech and Moderna vaccines are 75% effective against the escape variants, with lower efficacy for other vaccines. But booster shots may still be required to protect people against some variants.
Human factors
Human behavior will also help determine the course of the pandemic, he noted. Vaccine hesitancy, for example, is still high in the United States.
By the end of May, he predicted, about 180 million people will have received about two doses of vaccine. After that, he said, “vaccination will flatline due to lack of demand.” The two unknowns are how much campaigns to promote vaccination will increase vaccine confidence, and when children will be vaccinated.
In the United States, he said, 69% of adults have been vaccinated or want to get a shot. But that percentage has dropped 5 points since February, and vaccine confidence varies by state.
Dr. Murray emphasized that the winter surge he predicts can be blocked if people change their behaviors. These include a rise in vaccine confidence to 80% and continued mask wearing by most people.
However, if vaccine confidence and mask wearing decline, state governments continue to drop social distancing rules, and the uptake of boosters is low, the winter surge could be more serious, he said.
Double surge
Murray also raised the possibility of a double surge of COVID-19 and influenza this winter. Widely expected last winter, this double surge never materialized here or elsewhere, partly because of mask wearing. But Dr. Murray said it could happen this year: History shows that the flu tends to be stronger in years after weak outbreaks.
He advised hospitals to prepare now for whatever might come later this year. Public health authorities, he said, should speed up vaccination, monitor variants closely with additional sequencing, and try to modify behavior in high-risk groups.
Asked to explain the recent surge of COVID-19 cases in Michigan, Dr. Murray attributed it partly to the spread of the B.1.1.7 (U.K.) variant. But he noted that the U.K. variant has expanded even more widely in some other states that haven’t had an explosive surge like Michigan’s.
Moreover, he noted, Michigan doesn’t have low mask use or high mobility. So the upward spiral of COVID-19 infections there is very concerning, he said.
In regard to the role of children as reservoirs of the virus, Dr. Murray pointed out that views on this have changed around the world. For a while, people thought kids didn’t spread COVID-19 very much. That view shifted when U.K. data showed that child transmission of the B.1.1.7 variant increased by half to 9% of contacts in comparison with the original virus strain.
Dutch data, similarly, showed schools contributing to the latest outbreaks, and some European nations have closed schools. In the United States, the trend is to open them.
A version of this article first appeared on Medscape.com.
Microbiota-directed therapy may improve growth rate in malnourished children
according to new research.
Moderate acute malnutrition affects more than 30 million children worldwide, according to the Food and Nutrition Bulletin. The World Health Organization defines the condition by a weight-for-height measurement that is 2 or 3 standard deviations below the international standard.
A 2014 study published in Nature has shown that malnourishment is associated with defects in children’s gut microbiota, including having microbial communities that are immature and younger than those of their healthy counterparts. Microbiota immaturity also correlates with stunted growth.
The authors of new study, which was published in the New England Journal of Medicine on April 7, 2021, wrote that nutritional interventions and treatments, such as therapeutic calorie-dense foods, have limited effectiveness because they don’t restore growth or fully address repairing the gut microbiome.
“This work supports the notion that healthy growth of children is linked to healthy development of their gut microbiota,” study author Jeffrey Gordon, MD, director of the Edison Family Center for Genome Sciences & Systems Biology at Washington University, St. Louis, said in an interview. “This, in turn, indicates that we need to have a more encompassing view of human developmental biology – one that considers both our ‘human’ and ‘microbial’ parts.”
The study establishes the impact of microbiota repair on a child’s growth rate, which may have implications on policies related to complementary feeding practices, Dr. Gorden noted.
Better outcomes seen with microbiota-directed complementary food prototype
For the research, 123 children with moderate acute malnutrition aged between 12 and 18 months were randomly assigned to receive a microbiota-directed complementary food prototype (MDCF-2) or ready-to-use supplementary food (RUSF). The supplementation was given to the kids twice daily for 3 months, followed by 1 month of monitoring. They looked at the weekly rate of change in the weight-for-length z score, weight-for-age z score, mid-upper-arm circumference, length-for-age z score, medical complication, gut microbiota, and blood samples in the group to determine the effectiveness of each food intervention therapy.
They found that, of the 118 children who completed the study, those in the MDCF-2 group had better outcomes than those in the RUSF group based on greater weekly growth in z scores, indicating faster growth rates. For those in the MDCF-2 group, the mean weekly change in weight-for-length z score was 0.021, compared to the RUSF group’s 0.010. When it came to weight-for-age z score, the mean weekly change was 0.017 in the MDCF-2 group and 0.010 in the RUSF group. The mean weekly changes in the mid-upper-arm circumference and length-for-age z scores were similar in both groups.
When examining blood samples of the cohort, researchers noted that 714 proteins were significantly altered after 3-month MDCF-2 supplementation, compared with 82 proteins having shown significant alterations in the RUSF group.
Overall, the findings show that repairing gut microbiota was accompanied by improved weight gain and marked changes in circulating levels of protein biomarkers and mediators of numerous aspects of healthy growth.
Results need to be verified on a larger scale
Tim Joos, MD, who was not part of the study, said it is surprising that MDCF-2 was better at promoting growth than existing nutritional supplements.
“The study suggests that remedying malnutrition requires more than just ensuring adequate calorie and nutrient intake,” Dr. Joos, a pediatrician at NeighborCare Health in Seattle, noted in an interview. “It is a small study and needs to be verified on a larger scale and in more diverse locations and pediatric ages (outside of the 12- to 18-month-old cohort studied).”
Wendy S. Garrett, MD, PhD, who also didn’t participate in the study, wrote in an accompanying editorial that overarching questions remain concerning the long-lasting effects of the intervention on children’s growth trajectory and cognitive development. She also said that the study “provides an abundance of fascinating microbiome profile data, plasma protein correlates, and metadata to sift through.”
Dr. Gordon and colleagues said the findings underscore the broad effects gut microbiota has on human biology and they hope this will open the door to better definitions of wellness for infants/children.
Dr. Garrett is the Irene Heinz Given Professor of Immunology and Infectious Diseases in the departments of immunology and infectious diseases and of molecular metabolism at the Harvard School of Public Health, Boston, and she has no disclosures. Dr. Gordon is the recipient of a Thought Leader award from Agilent Technologies. Dr. Joos disclosed no relevant financial relationships.
according to new research.
Moderate acute malnutrition affects more than 30 million children worldwide, according to the Food and Nutrition Bulletin. The World Health Organization defines the condition by a weight-for-height measurement that is 2 or 3 standard deviations below the international standard.
A 2014 study published in Nature has shown that malnourishment is associated with defects in children’s gut microbiota, including having microbial communities that are immature and younger than those of their healthy counterparts. Microbiota immaturity also correlates with stunted growth.
The authors of new study, which was published in the New England Journal of Medicine on April 7, 2021, wrote that nutritional interventions and treatments, such as therapeutic calorie-dense foods, have limited effectiveness because they don’t restore growth or fully address repairing the gut microbiome.
“This work supports the notion that healthy growth of children is linked to healthy development of their gut microbiota,” study author Jeffrey Gordon, MD, director of the Edison Family Center for Genome Sciences & Systems Biology at Washington University, St. Louis, said in an interview. “This, in turn, indicates that we need to have a more encompassing view of human developmental biology – one that considers both our ‘human’ and ‘microbial’ parts.”
The study establishes the impact of microbiota repair on a child’s growth rate, which may have implications on policies related to complementary feeding practices, Dr. Gorden noted.
Better outcomes seen with microbiota-directed complementary food prototype
For the research, 123 children with moderate acute malnutrition aged between 12 and 18 months were randomly assigned to receive a microbiota-directed complementary food prototype (MDCF-2) or ready-to-use supplementary food (RUSF). The supplementation was given to the kids twice daily for 3 months, followed by 1 month of monitoring. They looked at the weekly rate of change in the weight-for-length z score, weight-for-age z score, mid-upper-arm circumference, length-for-age z score, medical complication, gut microbiota, and blood samples in the group to determine the effectiveness of each food intervention therapy.
They found that, of the 118 children who completed the study, those in the MDCF-2 group had better outcomes than those in the RUSF group based on greater weekly growth in z scores, indicating faster growth rates. For those in the MDCF-2 group, the mean weekly change in weight-for-length z score was 0.021, compared to the RUSF group’s 0.010. When it came to weight-for-age z score, the mean weekly change was 0.017 in the MDCF-2 group and 0.010 in the RUSF group. The mean weekly changes in the mid-upper-arm circumference and length-for-age z scores were similar in both groups.
When examining blood samples of the cohort, researchers noted that 714 proteins were significantly altered after 3-month MDCF-2 supplementation, compared with 82 proteins having shown significant alterations in the RUSF group.
Overall, the findings show that repairing gut microbiota was accompanied by improved weight gain and marked changes in circulating levels of protein biomarkers and mediators of numerous aspects of healthy growth.
Results need to be verified on a larger scale
Tim Joos, MD, who was not part of the study, said it is surprising that MDCF-2 was better at promoting growth than existing nutritional supplements.
“The study suggests that remedying malnutrition requires more than just ensuring adequate calorie and nutrient intake,” Dr. Joos, a pediatrician at NeighborCare Health in Seattle, noted in an interview. “It is a small study and needs to be verified on a larger scale and in more diverse locations and pediatric ages (outside of the 12- to 18-month-old cohort studied).”
Wendy S. Garrett, MD, PhD, who also didn’t participate in the study, wrote in an accompanying editorial that overarching questions remain concerning the long-lasting effects of the intervention on children’s growth trajectory and cognitive development. She also said that the study “provides an abundance of fascinating microbiome profile data, plasma protein correlates, and metadata to sift through.”
Dr. Gordon and colleagues said the findings underscore the broad effects gut microbiota has on human biology and they hope this will open the door to better definitions of wellness for infants/children.
Dr. Garrett is the Irene Heinz Given Professor of Immunology and Infectious Diseases in the departments of immunology and infectious diseases and of molecular metabolism at the Harvard School of Public Health, Boston, and she has no disclosures. Dr. Gordon is the recipient of a Thought Leader award from Agilent Technologies. Dr. Joos disclosed no relevant financial relationships.
according to new research.
Moderate acute malnutrition affects more than 30 million children worldwide, according to the Food and Nutrition Bulletin. The World Health Organization defines the condition by a weight-for-height measurement that is 2 or 3 standard deviations below the international standard.
A 2014 study published in Nature has shown that malnourishment is associated with defects in children’s gut microbiota, including having microbial communities that are immature and younger than those of their healthy counterparts. Microbiota immaturity also correlates with stunted growth.
The authors of new study, which was published in the New England Journal of Medicine on April 7, 2021, wrote that nutritional interventions and treatments, such as therapeutic calorie-dense foods, have limited effectiveness because they don’t restore growth or fully address repairing the gut microbiome.
“This work supports the notion that healthy growth of children is linked to healthy development of their gut microbiota,” study author Jeffrey Gordon, MD, director of the Edison Family Center for Genome Sciences & Systems Biology at Washington University, St. Louis, said in an interview. “This, in turn, indicates that we need to have a more encompassing view of human developmental biology – one that considers both our ‘human’ and ‘microbial’ parts.”
The study establishes the impact of microbiota repair on a child’s growth rate, which may have implications on policies related to complementary feeding practices, Dr. Gorden noted.
Better outcomes seen with microbiota-directed complementary food prototype
For the research, 123 children with moderate acute malnutrition aged between 12 and 18 months were randomly assigned to receive a microbiota-directed complementary food prototype (MDCF-2) or ready-to-use supplementary food (RUSF). The supplementation was given to the kids twice daily for 3 months, followed by 1 month of monitoring. They looked at the weekly rate of change in the weight-for-length z score, weight-for-age z score, mid-upper-arm circumference, length-for-age z score, medical complication, gut microbiota, and blood samples in the group to determine the effectiveness of each food intervention therapy.
They found that, of the 118 children who completed the study, those in the MDCF-2 group had better outcomes than those in the RUSF group based on greater weekly growth in z scores, indicating faster growth rates. For those in the MDCF-2 group, the mean weekly change in weight-for-length z score was 0.021, compared to the RUSF group’s 0.010. When it came to weight-for-age z score, the mean weekly change was 0.017 in the MDCF-2 group and 0.010 in the RUSF group. The mean weekly changes in the mid-upper-arm circumference and length-for-age z scores were similar in both groups.
When examining blood samples of the cohort, researchers noted that 714 proteins were significantly altered after 3-month MDCF-2 supplementation, compared with 82 proteins having shown significant alterations in the RUSF group.
Overall, the findings show that repairing gut microbiota was accompanied by improved weight gain and marked changes in circulating levels of protein biomarkers and mediators of numerous aspects of healthy growth.
Results need to be verified on a larger scale
Tim Joos, MD, who was not part of the study, said it is surprising that MDCF-2 was better at promoting growth than existing nutritional supplements.
“The study suggests that remedying malnutrition requires more than just ensuring adequate calorie and nutrient intake,” Dr. Joos, a pediatrician at NeighborCare Health in Seattle, noted in an interview. “It is a small study and needs to be verified on a larger scale and in more diverse locations and pediatric ages (outside of the 12- to 18-month-old cohort studied).”
Wendy S. Garrett, MD, PhD, who also didn’t participate in the study, wrote in an accompanying editorial that overarching questions remain concerning the long-lasting effects of the intervention on children’s growth trajectory and cognitive development. She also said that the study “provides an abundance of fascinating microbiome profile data, plasma protein correlates, and metadata to sift through.”
Dr. Gordon and colleagues said the findings underscore the broad effects gut microbiota has on human biology and they hope this will open the door to better definitions of wellness for infants/children.
Dr. Garrett is the Irene Heinz Given Professor of Immunology and Infectious Diseases in the departments of immunology and infectious diseases and of molecular metabolism at the Harvard School of Public Health, Boston, and she has no disclosures. Dr. Gordon is the recipient of a Thought Leader award from Agilent Technologies. Dr. Joos disclosed no relevant financial relationships.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
FDA, CDC urge pause of J&J COVID vaccine
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
Secukinumab brings high PASI 75 results in 6- to 17-year-olds with psoriasis
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY