User login
News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
Peripartum maternal oxygen supplementation shows little benefit
Peripartum maternal oxygen supplementation does not yield a clinically relevant improvement in umbilical artery gas pH or other neonatal outcomes, reported Nandini Raghuraman, MD, MS, of the Washington University School of Medicine, St. Louis, MO, and her associates.
In a meta-analysis of 16 studies identified between Feb. 18 and April 3, 2020, the investigators sought to determine whether maternal oxygen supplementation during delivery leads to improved measures in umbilical artery (UA) gas and neonatal outcomes. Using data from randomized clinical trials, they compared peripartum oxygen supplementation with room air and examined the link between oxygen delivery during regular labor or planned cesarean delivery (CD) with UA gas measures and other neonatal outcomes.
Altogether, 1,078 patients were randomized to the oxygen group or the room air group. UA pH remained similar between the two groups even after the researchers factored in risk of bias, use of low-flow devices, or FIO2 below 60%, noted the authors. Oxygen supplementation also appeared to reduce rates of UA pH that were less than 7.2 and increase UA PaO2 relative to room air during scheduled cesarean deliveries, they added.
Considerable interstudy heterogeneity was found
Although marginally lower one-minute Apgar scores were observed in infants whose mothers received oxygen during cesarean delivery, the mean difference between oxygen and room air was less than a point and there were no other statistically significant differences in any secondary outcomes, the authors said. Considerable interstudy heterogeneity was noted across most of the study outcomes.
It is important to note that results pooled from all the studies reviewed indicated an increase in UA PaO2 but no notable differences in UA pH when oxygen was used. Citing multiple studies included in the review, the authors observed that UA PaO2 is a “poor estimator of neonatal morbidity” because, when evaluated in cord blood gas, it represents dissolved oxygen and is not an accurate indication of how much oxygen is bound to hemoglobin. For this reason, dissolved oxygen content by itself is not an indication of hypoxia or subpar tissue oxygenation.
“Prolonged tissue hypoxia leads to anaerobic metabolism, resulting in decreased pH, which is why UA pH ultimately serves as a better marker for prediction of neonatal morbidity. An intervention that increases the PaO2 without concomitantly increasing the pH has limited clinical benefit, particularly because hyperoxemia is associated with production of free radicals and oxidative cell damage in adults and neonates,” they explained.
With unproven benefits and potential for risk of harm, prolonged oxygen use should be limited
“A large, adequately powered trial is needed to investigate the effect of maternal oxygen supplementation in response to fetal heart rate tracings on short- and long-term neonatal morbidity,” the authors suggested. For the time being, they cautioned limiting prolonged oxygen use since the benefits are unproven and there is a potential risk of harm.
In a separate interview, Iris Krishna, MD, MPH, FACOG, Emory University, Atlanta, noted, “The use of maternal supplemental oxygen with the intent of improving fetal oxygenation is a common clinical practice. Previous studies on maternal oxygen supplementation during labor have yielded conflicting results; however, there is growing literature suggesting that maternal intrapartum supplemental oxygenation may not provide clinically significant benefit and there may even be potential harm to mother and baby.
“Unique to this meta-analysis is evaluation of maternal oxygen supplementation in the presence or absence of labor, hypothesizing that placental oxygen transfer may be affected by regular uterine contractions. The pooled results suggest that the use of maternal supplemental oxygenation does not result in clinically relevant fetal oxygenation in the presence or absence of labor when compared to room air. A limitation of this meta-analysis is that the use of oxygen in response to nonreassuring fetal tracing was not assessed, the most common clinical indication for maternal oxygen supplementation.
“This study further challenges the practice of maternal intrapartum supplemental oxygen and highlights that we have much to learn about the impact of this practice. More research is needed to assess optimal duration of oxygen supplementation, safety and efficacy of oxygen supplementation, appropriate clinical indications for oxygen supplementation, as well as the long-term neonatal outcomes of in utero hyperoxygenation.“
Dr. Raghuraman reported receiving multiple grants and acknowledged multiple funding sources. Her colleagues and Dr. Krishna had no conflicts of interest to report.
Peripartum maternal oxygen supplementation does not yield a clinically relevant improvement in umbilical artery gas pH or other neonatal outcomes, reported Nandini Raghuraman, MD, MS, of the Washington University School of Medicine, St. Louis, MO, and her associates.
In a meta-analysis of 16 studies identified between Feb. 18 and April 3, 2020, the investigators sought to determine whether maternal oxygen supplementation during delivery leads to improved measures in umbilical artery (UA) gas and neonatal outcomes. Using data from randomized clinical trials, they compared peripartum oxygen supplementation with room air and examined the link between oxygen delivery during regular labor or planned cesarean delivery (CD) with UA gas measures and other neonatal outcomes.
Altogether, 1,078 patients were randomized to the oxygen group or the room air group. UA pH remained similar between the two groups even after the researchers factored in risk of bias, use of low-flow devices, or FIO2 below 60%, noted the authors. Oxygen supplementation also appeared to reduce rates of UA pH that were less than 7.2 and increase UA PaO2 relative to room air during scheduled cesarean deliveries, they added.
Considerable interstudy heterogeneity was found
Although marginally lower one-minute Apgar scores were observed in infants whose mothers received oxygen during cesarean delivery, the mean difference between oxygen and room air was less than a point and there were no other statistically significant differences in any secondary outcomes, the authors said. Considerable interstudy heterogeneity was noted across most of the study outcomes.
It is important to note that results pooled from all the studies reviewed indicated an increase in UA PaO2 but no notable differences in UA pH when oxygen was used. Citing multiple studies included in the review, the authors observed that UA PaO2 is a “poor estimator of neonatal morbidity” because, when evaluated in cord blood gas, it represents dissolved oxygen and is not an accurate indication of how much oxygen is bound to hemoglobin. For this reason, dissolved oxygen content by itself is not an indication of hypoxia or subpar tissue oxygenation.
“Prolonged tissue hypoxia leads to anaerobic metabolism, resulting in decreased pH, which is why UA pH ultimately serves as a better marker for prediction of neonatal morbidity. An intervention that increases the PaO2 without concomitantly increasing the pH has limited clinical benefit, particularly because hyperoxemia is associated with production of free radicals and oxidative cell damage in adults and neonates,” they explained.
With unproven benefits and potential for risk of harm, prolonged oxygen use should be limited
“A large, adequately powered trial is needed to investigate the effect of maternal oxygen supplementation in response to fetal heart rate tracings on short- and long-term neonatal morbidity,” the authors suggested. For the time being, they cautioned limiting prolonged oxygen use since the benefits are unproven and there is a potential risk of harm.
In a separate interview, Iris Krishna, MD, MPH, FACOG, Emory University, Atlanta, noted, “The use of maternal supplemental oxygen with the intent of improving fetal oxygenation is a common clinical practice. Previous studies on maternal oxygen supplementation during labor have yielded conflicting results; however, there is growing literature suggesting that maternal intrapartum supplemental oxygenation may not provide clinically significant benefit and there may even be potential harm to mother and baby.
“Unique to this meta-analysis is evaluation of maternal oxygen supplementation in the presence or absence of labor, hypothesizing that placental oxygen transfer may be affected by regular uterine contractions. The pooled results suggest that the use of maternal supplemental oxygenation does not result in clinically relevant fetal oxygenation in the presence or absence of labor when compared to room air. A limitation of this meta-analysis is that the use of oxygen in response to nonreassuring fetal tracing was not assessed, the most common clinical indication for maternal oxygen supplementation.
“This study further challenges the practice of maternal intrapartum supplemental oxygen and highlights that we have much to learn about the impact of this practice. More research is needed to assess optimal duration of oxygen supplementation, safety and efficacy of oxygen supplementation, appropriate clinical indications for oxygen supplementation, as well as the long-term neonatal outcomes of in utero hyperoxygenation.“
Dr. Raghuraman reported receiving multiple grants and acknowledged multiple funding sources. Her colleagues and Dr. Krishna had no conflicts of interest to report.
Peripartum maternal oxygen supplementation does not yield a clinically relevant improvement in umbilical artery gas pH or other neonatal outcomes, reported Nandini Raghuraman, MD, MS, of the Washington University School of Medicine, St. Louis, MO, and her associates.
In a meta-analysis of 16 studies identified between Feb. 18 and April 3, 2020, the investigators sought to determine whether maternal oxygen supplementation during delivery leads to improved measures in umbilical artery (UA) gas and neonatal outcomes. Using data from randomized clinical trials, they compared peripartum oxygen supplementation with room air and examined the link between oxygen delivery during regular labor or planned cesarean delivery (CD) with UA gas measures and other neonatal outcomes.
Altogether, 1,078 patients were randomized to the oxygen group or the room air group. UA pH remained similar between the two groups even after the researchers factored in risk of bias, use of low-flow devices, or FIO2 below 60%, noted the authors. Oxygen supplementation also appeared to reduce rates of UA pH that were less than 7.2 and increase UA PaO2 relative to room air during scheduled cesarean deliveries, they added.
Considerable interstudy heterogeneity was found
Although marginally lower one-minute Apgar scores were observed in infants whose mothers received oxygen during cesarean delivery, the mean difference between oxygen and room air was less than a point and there were no other statistically significant differences in any secondary outcomes, the authors said. Considerable interstudy heterogeneity was noted across most of the study outcomes.
It is important to note that results pooled from all the studies reviewed indicated an increase in UA PaO2 but no notable differences in UA pH when oxygen was used. Citing multiple studies included in the review, the authors observed that UA PaO2 is a “poor estimator of neonatal morbidity” because, when evaluated in cord blood gas, it represents dissolved oxygen and is not an accurate indication of how much oxygen is bound to hemoglobin. For this reason, dissolved oxygen content by itself is not an indication of hypoxia or subpar tissue oxygenation.
“Prolonged tissue hypoxia leads to anaerobic metabolism, resulting in decreased pH, which is why UA pH ultimately serves as a better marker for prediction of neonatal morbidity. An intervention that increases the PaO2 without concomitantly increasing the pH has limited clinical benefit, particularly because hyperoxemia is associated with production of free radicals and oxidative cell damage in adults and neonates,” they explained.
With unproven benefits and potential for risk of harm, prolonged oxygen use should be limited
“A large, adequately powered trial is needed to investigate the effect of maternal oxygen supplementation in response to fetal heart rate tracings on short- and long-term neonatal morbidity,” the authors suggested. For the time being, they cautioned limiting prolonged oxygen use since the benefits are unproven and there is a potential risk of harm.
In a separate interview, Iris Krishna, MD, MPH, FACOG, Emory University, Atlanta, noted, “The use of maternal supplemental oxygen with the intent of improving fetal oxygenation is a common clinical practice. Previous studies on maternal oxygen supplementation during labor have yielded conflicting results; however, there is growing literature suggesting that maternal intrapartum supplemental oxygenation may not provide clinically significant benefit and there may even be potential harm to mother and baby.
“Unique to this meta-analysis is evaluation of maternal oxygen supplementation in the presence or absence of labor, hypothesizing that placental oxygen transfer may be affected by regular uterine contractions. The pooled results suggest that the use of maternal supplemental oxygenation does not result in clinically relevant fetal oxygenation in the presence or absence of labor when compared to room air. A limitation of this meta-analysis is that the use of oxygen in response to nonreassuring fetal tracing was not assessed, the most common clinical indication for maternal oxygen supplementation.
“This study further challenges the practice of maternal intrapartum supplemental oxygen and highlights that we have much to learn about the impact of this practice. More research is needed to assess optimal duration of oxygen supplementation, safety and efficacy of oxygen supplementation, appropriate clinical indications for oxygen supplementation, as well as the long-term neonatal outcomes of in utero hyperoxygenation.“
Dr. Raghuraman reported receiving multiple grants and acknowledged multiple funding sources. Her colleagues and Dr. Krishna had no conflicts of interest to report.
FROM JAMA PEDIATRICS
President Biden kicks off health agenda with COVID actions, WHO outreach
President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.
Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.
At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.
The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.
Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.
The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.
The American Medical Association was among the first to commend the first-day actions.
“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”
A version of this article first appeared on Medscape.com.
President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.
Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.
At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.
The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.
Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.
The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.
The American Medical Association was among the first to commend the first-day actions.
“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”
A version of this article first appeared on Medscape.com.
President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.
Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.
At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.
The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.
Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.
The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.
The American Medical Association was among the first to commend the first-day actions.
“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”
A version of this article first appeared on Medscape.com.
Patients fend for themselves to access highly touted COVID antibody treatments
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Biden’s COVID-19 challenge: 100 million vaccinations in the first 100 days. It won’t be easy.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
Many EM docs have treated COVID-19 patients without proper PPE: Survey
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
How COVID-19 will continue to alter patient visits
Finding the current domestic and global situations too disheartening to write about, I have decided for the moment to take the long view in hopes of finding something to stimulate your imaginations. It appears that we have several vaccines effective against SARS-CoV-2 if not in your hands at the moment at least in someone’s freezer or at the very least somewhere near beginning of their journey in the production pipeline. It may be a year of more but thanks to the vaccines and herd immunity there will be a time when parents may feel more comfortable about bringing their children into your office. How are you going to dial back your office routine to something even vaguely familiar?
To keep your office afloat financially you have probably been forced to adopt and adapt telemedicine strategies to your practice style. Prior to the pandemic you may have been among the few who were actively experimenting with practicing remotely. But, it is more likely that you had given little serious thought to how you would manage your patients without them being physically present.
You probably carried in your mind a list of symptoms and complaints which you had promised yourself that you would never treat without first laying eyes and hands on the patient. You may have even codified this list into a set of guidelines that you included in the office manual for your nurses, assistants, and receptionists. You may have looked askance at some of your colleagues whom you felt too often treated their patients (and yours when they were covering) based on what seemed to be scanty information gleaned from a phone call. The impropriety of this kind of clinical behavior may have even come up at staff meetings or at least been the topic of hallway discussions.
How did your list of complaints that demanded an in-person visit evolve? I suspect that in large part it was formed as you modeled the behavior of your mentors and teachers. In some cases you may have heard of tragic cases in which a child had died or suffered serious consequences of being treated without an in-person evaluation. In many cases you were following a tradition or ethic that said treating in certain circumstances without an exam just wasn’t done.
Have the realities of the pandemic forced you to alter your list of must-see-before-I’ll-treat complaints? Have you found yourself calling in antibiotic prescriptions for children with ear pain who 1 year ago you would have told to come in for an office visit? Are you treating “strep throats” without a rapid strep test or culture? How many stimulant prescriptions have you refilled for children who haven’t been reevaluated in the office in over a year? How are you going to manage the tsunami of requests for sports physicals once the junior high and high school teams are allowed to return to action? You probably won’t have the time to examine all of the sports candidates who show up in your office with crumpled forms recently retrieved from crumb-filled backpacks.
Where are you going to reset the bar as the pandemic lifts and the barriers that have prevented patients from coming to your office over the last year or year and a half recede? Have you realized that many of your office visits in prepandemic times were unnecessary? How many children with otitis really needed to be followed up with an ear recheck visit? Which children with sore throats and a fever needed to be examined? Was a yearly exam really necessary for a high school sophomore who wanted to play basketball? Has your comfort zone widened to include more patient complaints that can be managed without a face to face encounter? Where will telemedicine fit into the mix?
At some time in the next 12 months you will have to recalibrate and reset the bar. It will probably be a gradual process that in large part can be molded by the responses of the families who may have also come to realize that seeing you in the office isn’t quite as necessary as you both may have thought it was.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com
Finding the current domestic and global situations too disheartening to write about, I have decided for the moment to take the long view in hopes of finding something to stimulate your imaginations. It appears that we have several vaccines effective against SARS-CoV-2 if not in your hands at the moment at least in someone’s freezer or at the very least somewhere near beginning of their journey in the production pipeline. It may be a year of more but thanks to the vaccines and herd immunity there will be a time when parents may feel more comfortable about bringing their children into your office. How are you going to dial back your office routine to something even vaguely familiar?
To keep your office afloat financially you have probably been forced to adopt and adapt telemedicine strategies to your practice style. Prior to the pandemic you may have been among the few who were actively experimenting with practicing remotely. But, it is more likely that you had given little serious thought to how you would manage your patients without them being physically present.
You probably carried in your mind a list of symptoms and complaints which you had promised yourself that you would never treat without first laying eyes and hands on the patient. You may have even codified this list into a set of guidelines that you included in the office manual for your nurses, assistants, and receptionists. You may have looked askance at some of your colleagues whom you felt too often treated their patients (and yours when they were covering) based on what seemed to be scanty information gleaned from a phone call. The impropriety of this kind of clinical behavior may have even come up at staff meetings or at least been the topic of hallway discussions.
How did your list of complaints that demanded an in-person visit evolve? I suspect that in large part it was formed as you modeled the behavior of your mentors and teachers. In some cases you may have heard of tragic cases in which a child had died or suffered serious consequences of being treated without an in-person evaluation. In many cases you were following a tradition or ethic that said treating in certain circumstances without an exam just wasn’t done.
Have the realities of the pandemic forced you to alter your list of must-see-before-I’ll-treat complaints? Have you found yourself calling in antibiotic prescriptions for children with ear pain who 1 year ago you would have told to come in for an office visit? Are you treating “strep throats” without a rapid strep test or culture? How many stimulant prescriptions have you refilled for children who haven’t been reevaluated in the office in over a year? How are you going to manage the tsunami of requests for sports physicals once the junior high and high school teams are allowed to return to action? You probably won’t have the time to examine all of the sports candidates who show up in your office with crumpled forms recently retrieved from crumb-filled backpacks.
Where are you going to reset the bar as the pandemic lifts and the barriers that have prevented patients from coming to your office over the last year or year and a half recede? Have you realized that many of your office visits in prepandemic times were unnecessary? How many children with otitis really needed to be followed up with an ear recheck visit? Which children with sore throats and a fever needed to be examined? Was a yearly exam really necessary for a high school sophomore who wanted to play basketball? Has your comfort zone widened to include more patient complaints that can be managed without a face to face encounter? Where will telemedicine fit into the mix?
At some time in the next 12 months you will have to recalibrate and reset the bar. It will probably be a gradual process that in large part can be molded by the responses of the families who may have also come to realize that seeing you in the office isn’t quite as necessary as you both may have thought it was.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com
Finding the current domestic and global situations too disheartening to write about, I have decided for the moment to take the long view in hopes of finding something to stimulate your imaginations. It appears that we have several vaccines effective against SARS-CoV-2 if not in your hands at the moment at least in someone’s freezer or at the very least somewhere near beginning of their journey in the production pipeline. It may be a year of more but thanks to the vaccines and herd immunity there will be a time when parents may feel more comfortable about bringing their children into your office. How are you going to dial back your office routine to something even vaguely familiar?
To keep your office afloat financially you have probably been forced to adopt and adapt telemedicine strategies to your practice style. Prior to the pandemic you may have been among the few who were actively experimenting with practicing remotely. But, it is more likely that you had given little serious thought to how you would manage your patients without them being physically present.
You probably carried in your mind a list of symptoms and complaints which you had promised yourself that you would never treat without first laying eyes and hands on the patient. You may have even codified this list into a set of guidelines that you included in the office manual for your nurses, assistants, and receptionists. You may have looked askance at some of your colleagues whom you felt too often treated their patients (and yours when they were covering) based on what seemed to be scanty information gleaned from a phone call. The impropriety of this kind of clinical behavior may have even come up at staff meetings or at least been the topic of hallway discussions.
How did your list of complaints that demanded an in-person visit evolve? I suspect that in large part it was formed as you modeled the behavior of your mentors and teachers. In some cases you may have heard of tragic cases in which a child had died or suffered serious consequences of being treated without an in-person evaluation. In many cases you were following a tradition or ethic that said treating in certain circumstances without an exam just wasn’t done.
Have the realities of the pandemic forced you to alter your list of must-see-before-I’ll-treat complaints? Have you found yourself calling in antibiotic prescriptions for children with ear pain who 1 year ago you would have told to come in for an office visit? Are you treating “strep throats” without a rapid strep test or culture? How many stimulant prescriptions have you refilled for children who haven’t been reevaluated in the office in over a year? How are you going to manage the tsunami of requests for sports physicals once the junior high and high school teams are allowed to return to action? You probably won’t have the time to examine all of the sports candidates who show up in your office with crumpled forms recently retrieved from crumb-filled backpacks.
Where are you going to reset the bar as the pandemic lifts and the barriers that have prevented patients from coming to your office over the last year or year and a half recede? Have you realized that many of your office visits in prepandemic times were unnecessary? How many children with otitis really needed to be followed up with an ear recheck visit? Which children with sore throats and a fever needed to be examined? Was a yearly exam really necessary for a high school sophomore who wanted to play basketball? Has your comfort zone widened to include more patient complaints that can be managed without a face to face encounter? Where will telemedicine fit into the mix?
At some time in the next 12 months you will have to recalibrate and reset the bar. It will probably be a gradual process that in large part can be molded by the responses of the families who may have also come to realize that seeing you in the office isn’t quite as necessary as you both may have thought it was.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com
Early Head Start program boosts healthy eating, self-regulation
Home-based preventive interventions not only improve healthy eating habits and self-regulation in toddlers but also guide their parents toward better food presentation and response to picky behaviors, reported Robert L. Nix, PhD, of the University of Wisconsin, Madison, and his associates.
In a small, randomized controlled trial of 73 families with toddlers aged 18-36 months enrolled in home-based Early Head Start (EHS), the researchers evaluated four protective factors, including toddlers’ healthy eating habits, toddlers’ self-regulation, parents’ responsive feeding practices, and parents’ sensitive scaffolding. The study, conducted from April to October 2013, is the first clinical trial of Recipe 4 Success, a preschool-focused intervention created by administrators and home visitors of EHS that promotes healthy eating and self-regulation in toddlers living in poverty who may otherwise face weight challenges and obesity later in life. Integrating the intervention into EHS allowed the researchers to take full advantage of its national infrastructure and to make dissemination more efficient.
Of the families selected to participate, all of whom were living below the Federal poverty threshold, 66 were retained through post treatment. Most participating parents were biological mothers; 61% were single; 29% were not high school graduates; just 11% were employed full time. The toddlers averaged 30.72 months; 44% were female. Roughly 48% of families were non-Hispanic White; 29% were Black; and 23% were Hispanic or Latinx, the investigators reported in Pediatrics. More than three-quarters of participants were enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children or the Supplemental Nutrition Assistance Program.
The program allowed parents to transform toddler eating habits quickly
The study, which was designed to evaluate for posttreatment differences in the primary outcomes, involved 10 consecutive weekly lessons implemented by regularly assigned EHS home visitors. Parents were required to adhere to feeding practices carefully targeted with sensitive, structured scaffolding designed to keep toddlers from becoming overwhelmed. Parents were guided to understand, for instance, that toddlers frequently need to be exposed to a new food 10-20 times before eating it, and that poor sleep can have a detrimental influence on emotional and behavioral controls that can progress to weight gain.
Parent recall of what food and drinks their toddlers consumed in the previous 24-hour period was collected by interviewers. The percentage of all meals that included a fruit and/or vegetable, a protein source, and the absence of sweets and junk food were noted. Toddler self-regulation was assessed in accordance with delay of gratification, task orientation, and emotional/behavioral control. Parents were asked to rate toddler ability to cease desired activities to comply with parental requests. Parental responsive feeding practices were also recorded to observe how they introduce unique healthy foods and how they responded to their toddlers’ reactions. Parental sensitive scaffolding was similarly observed for their ability to structure activities in a developmentally appropriate manner promoting self-regulation.
The researchers noted no statistically significant differences between families in the treatment and control groups, nor were there differences in outcome measures or covariates. Study findings showed that, compared with toddlers who continued to receive just EHS support, the toddlers randomly assigned to Recipe 4 Success were more likely to consume snacks and meals that contained fruits, vegetables, protein, and no sweets or junk food.
As the results of this study and others have shown, early food preferences offer the strongest indication of later diet and healthy eating habits throughout life. The program targeted in this study is significant in its ability to accelerate the adoption of better toddler eating habits in just a 10-week period.
Recipe 4 Success along with other successful preventive interventions for young children are most effective when parents drive the change. “In the present trial, the quality of parenting was most highly related to healthy eating habits and self-regulation at baseline,” the researchers noted.
Specifically, the authors attributed the success of the program to “targeting specific interrelated outcomes with an integrated, theoretically driven intervention model,” which allowed Recipe 4 Success to boost the effectiveness of EHS substantially “in just 10 weeks with a minimal increase in funding,” the authors added.
The authors noted several weaknesses as well as strengths of the study. Its primary weakness was a baseline-posttreatment design, which made it impossible to assert that intervention effects can be sustained. The study was also limited to English-speaking families. Given that most home visitors attended to families in both Recipe 4 Success and EHS, the researchers noted the possibility for contamination across conditions, but they added that this would have actually reduced the intervention effects. The study’s primary strength was the evidenced-based nature of the randomized control. That Recipe 4 Success was operated as an intervention only strengthen the benefits of normal EHS visits.
Patient parents who promote self-regulation have the best chance of success
“This small study emphasizes the importance of parent education and support in setting the toddlers’ palate for lifelong eating habits and self-regulation,” observed Silver Spring, MD, private practice pediatrician and associate clinical professor of pediatrics at George Washington University, Washington, Lillian M. Beard, MD, in a separate interview.
“With the goal of promoting eating habits and self-regulation, I try to guide parents’ choices of what they offer to their toddler. I applaud parents’ patience as I encourage them not to give in and quickly resort to offering salty or sweet snacks. I suggest that if during the course of a day, a palette of colorful healthy choices is offered, most toddlers will graze independently as they go about their play. The challenge is to really support the parent through this quirky stage of their child’s development,” she explained.
“The ultimate challenge today with so much food insecurity, COVID-19 related job losses, and shrinking dollars to feed families is that too many families are feeling a food crisis! A program such as Recipe 4 Success can provide invaluable education for families on how to best stretch their few dollars, with knowledge of which items to seek from their community food pantries, how to best utilize items from the State WIC programs and still seek nutrition tips from their pediatricians while avoiding expensive fast foods that only offer immediate satiety and gratification. The Recipe 4 Success educator, pediatrician, or any community educator can give recommendations about which fresh produce may be inexpensive, but nutritional,” Dr. Beard suggested.
Dr. Nix and colleagues as well as Dr. Beard had no conflicts of interest and no relevant financial disclosures.
Home-based preventive interventions not only improve healthy eating habits and self-regulation in toddlers but also guide their parents toward better food presentation and response to picky behaviors, reported Robert L. Nix, PhD, of the University of Wisconsin, Madison, and his associates.
In a small, randomized controlled trial of 73 families with toddlers aged 18-36 months enrolled in home-based Early Head Start (EHS), the researchers evaluated four protective factors, including toddlers’ healthy eating habits, toddlers’ self-regulation, parents’ responsive feeding practices, and parents’ sensitive scaffolding. The study, conducted from April to October 2013, is the first clinical trial of Recipe 4 Success, a preschool-focused intervention created by administrators and home visitors of EHS that promotes healthy eating and self-regulation in toddlers living in poverty who may otherwise face weight challenges and obesity later in life. Integrating the intervention into EHS allowed the researchers to take full advantage of its national infrastructure and to make dissemination more efficient.
Of the families selected to participate, all of whom were living below the Federal poverty threshold, 66 were retained through post treatment. Most participating parents were biological mothers; 61% were single; 29% were not high school graduates; just 11% were employed full time. The toddlers averaged 30.72 months; 44% were female. Roughly 48% of families were non-Hispanic White; 29% were Black; and 23% were Hispanic or Latinx, the investigators reported in Pediatrics. More than three-quarters of participants were enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children or the Supplemental Nutrition Assistance Program.
The program allowed parents to transform toddler eating habits quickly
The study, which was designed to evaluate for posttreatment differences in the primary outcomes, involved 10 consecutive weekly lessons implemented by regularly assigned EHS home visitors. Parents were required to adhere to feeding practices carefully targeted with sensitive, structured scaffolding designed to keep toddlers from becoming overwhelmed. Parents were guided to understand, for instance, that toddlers frequently need to be exposed to a new food 10-20 times before eating it, and that poor sleep can have a detrimental influence on emotional and behavioral controls that can progress to weight gain.
Parent recall of what food and drinks their toddlers consumed in the previous 24-hour period was collected by interviewers. The percentage of all meals that included a fruit and/or vegetable, a protein source, and the absence of sweets and junk food were noted. Toddler self-regulation was assessed in accordance with delay of gratification, task orientation, and emotional/behavioral control. Parents were asked to rate toddler ability to cease desired activities to comply with parental requests. Parental responsive feeding practices were also recorded to observe how they introduce unique healthy foods and how they responded to their toddlers’ reactions. Parental sensitive scaffolding was similarly observed for their ability to structure activities in a developmentally appropriate manner promoting self-regulation.
The researchers noted no statistically significant differences between families in the treatment and control groups, nor were there differences in outcome measures or covariates. Study findings showed that, compared with toddlers who continued to receive just EHS support, the toddlers randomly assigned to Recipe 4 Success were more likely to consume snacks and meals that contained fruits, vegetables, protein, and no sweets or junk food.
As the results of this study and others have shown, early food preferences offer the strongest indication of later diet and healthy eating habits throughout life. The program targeted in this study is significant in its ability to accelerate the adoption of better toddler eating habits in just a 10-week period.
Recipe 4 Success along with other successful preventive interventions for young children are most effective when parents drive the change. “In the present trial, the quality of parenting was most highly related to healthy eating habits and self-regulation at baseline,” the researchers noted.
Specifically, the authors attributed the success of the program to “targeting specific interrelated outcomes with an integrated, theoretically driven intervention model,” which allowed Recipe 4 Success to boost the effectiveness of EHS substantially “in just 10 weeks with a minimal increase in funding,” the authors added.
The authors noted several weaknesses as well as strengths of the study. Its primary weakness was a baseline-posttreatment design, which made it impossible to assert that intervention effects can be sustained. The study was also limited to English-speaking families. Given that most home visitors attended to families in both Recipe 4 Success and EHS, the researchers noted the possibility for contamination across conditions, but they added that this would have actually reduced the intervention effects. The study’s primary strength was the evidenced-based nature of the randomized control. That Recipe 4 Success was operated as an intervention only strengthen the benefits of normal EHS visits.
Patient parents who promote self-regulation have the best chance of success
“This small study emphasizes the importance of parent education and support in setting the toddlers’ palate for lifelong eating habits and self-regulation,” observed Silver Spring, MD, private practice pediatrician and associate clinical professor of pediatrics at George Washington University, Washington, Lillian M. Beard, MD, in a separate interview.
“With the goal of promoting eating habits and self-regulation, I try to guide parents’ choices of what they offer to their toddler. I applaud parents’ patience as I encourage them not to give in and quickly resort to offering salty or sweet snacks. I suggest that if during the course of a day, a palette of colorful healthy choices is offered, most toddlers will graze independently as they go about their play. The challenge is to really support the parent through this quirky stage of their child’s development,” she explained.
“The ultimate challenge today with so much food insecurity, COVID-19 related job losses, and shrinking dollars to feed families is that too many families are feeling a food crisis! A program such as Recipe 4 Success can provide invaluable education for families on how to best stretch their few dollars, with knowledge of which items to seek from their community food pantries, how to best utilize items from the State WIC programs and still seek nutrition tips from their pediatricians while avoiding expensive fast foods that only offer immediate satiety and gratification. The Recipe 4 Success educator, pediatrician, or any community educator can give recommendations about which fresh produce may be inexpensive, but nutritional,” Dr. Beard suggested.
Dr. Nix and colleagues as well as Dr. Beard had no conflicts of interest and no relevant financial disclosures.
Home-based preventive interventions not only improve healthy eating habits and self-regulation in toddlers but also guide their parents toward better food presentation and response to picky behaviors, reported Robert L. Nix, PhD, of the University of Wisconsin, Madison, and his associates.
In a small, randomized controlled trial of 73 families with toddlers aged 18-36 months enrolled in home-based Early Head Start (EHS), the researchers evaluated four protective factors, including toddlers’ healthy eating habits, toddlers’ self-regulation, parents’ responsive feeding practices, and parents’ sensitive scaffolding. The study, conducted from April to October 2013, is the first clinical trial of Recipe 4 Success, a preschool-focused intervention created by administrators and home visitors of EHS that promotes healthy eating and self-regulation in toddlers living in poverty who may otherwise face weight challenges and obesity later in life. Integrating the intervention into EHS allowed the researchers to take full advantage of its national infrastructure and to make dissemination more efficient.
Of the families selected to participate, all of whom were living below the Federal poverty threshold, 66 were retained through post treatment. Most participating parents were biological mothers; 61% were single; 29% were not high school graduates; just 11% were employed full time. The toddlers averaged 30.72 months; 44% were female. Roughly 48% of families were non-Hispanic White; 29% were Black; and 23% were Hispanic or Latinx, the investigators reported in Pediatrics. More than three-quarters of participants were enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children or the Supplemental Nutrition Assistance Program.
The program allowed parents to transform toddler eating habits quickly
The study, which was designed to evaluate for posttreatment differences in the primary outcomes, involved 10 consecutive weekly lessons implemented by regularly assigned EHS home visitors. Parents were required to adhere to feeding practices carefully targeted with sensitive, structured scaffolding designed to keep toddlers from becoming overwhelmed. Parents were guided to understand, for instance, that toddlers frequently need to be exposed to a new food 10-20 times before eating it, and that poor sleep can have a detrimental influence on emotional and behavioral controls that can progress to weight gain.
Parent recall of what food and drinks their toddlers consumed in the previous 24-hour period was collected by interviewers. The percentage of all meals that included a fruit and/or vegetable, a protein source, and the absence of sweets and junk food were noted. Toddler self-regulation was assessed in accordance with delay of gratification, task orientation, and emotional/behavioral control. Parents were asked to rate toddler ability to cease desired activities to comply with parental requests. Parental responsive feeding practices were also recorded to observe how they introduce unique healthy foods and how they responded to their toddlers’ reactions. Parental sensitive scaffolding was similarly observed for their ability to structure activities in a developmentally appropriate manner promoting self-regulation.
The researchers noted no statistically significant differences between families in the treatment and control groups, nor were there differences in outcome measures or covariates. Study findings showed that, compared with toddlers who continued to receive just EHS support, the toddlers randomly assigned to Recipe 4 Success were more likely to consume snacks and meals that contained fruits, vegetables, protein, and no sweets or junk food.
As the results of this study and others have shown, early food preferences offer the strongest indication of later diet and healthy eating habits throughout life. The program targeted in this study is significant in its ability to accelerate the adoption of better toddler eating habits in just a 10-week period.
Recipe 4 Success along with other successful preventive interventions for young children are most effective when parents drive the change. “In the present trial, the quality of parenting was most highly related to healthy eating habits and self-regulation at baseline,” the researchers noted.
Specifically, the authors attributed the success of the program to “targeting specific interrelated outcomes with an integrated, theoretically driven intervention model,” which allowed Recipe 4 Success to boost the effectiveness of EHS substantially “in just 10 weeks with a minimal increase in funding,” the authors added.
The authors noted several weaknesses as well as strengths of the study. Its primary weakness was a baseline-posttreatment design, which made it impossible to assert that intervention effects can be sustained. The study was also limited to English-speaking families. Given that most home visitors attended to families in both Recipe 4 Success and EHS, the researchers noted the possibility for contamination across conditions, but they added that this would have actually reduced the intervention effects. The study’s primary strength was the evidenced-based nature of the randomized control. That Recipe 4 Success was operated as an intervention only strengthen the benefits of normal EHS visits.
Patient parents who promote self-regulation have the best chance of success
“This small study emphasizes the importance of parent education and support in setting the toddlers’ palate for lifelong eating habits and self-regulation,” observed Silver Spring, MD, private practice pediatrician and associate clinical professor of pediatrics at George Washington University, Washington, Lillian M. Beard, MD, in a separate interview.
“With the goal of promoting eating habits and self-regulation, I try to guide parents’ choices of what they offer to their toddler. I applaud parents’ patience as I encourage them not to give in and quickly resort to offering salty or sweet snacks. I suggest that if during the course of a day, a palette of colorful healthy choices is offered, most toddlers will graze independently as they go about their play. The challenge is to really support the parent through this quirky stage of their child’s development,” she explained.
“The ultimate challenge today with so much food insecurity, COVID-19 related job losses, and shrinking dollars to feed families is that too many families are feeling a food crisis! A program such as Recipe 4 Success can provide invaluable education for families on how to best stretch their few dollars, with knowledge of which items to seek from their community food pantries, how to best utilize items from the State WIC programs and still seek nutrition tips from their pediatricians while avoiding expensive fast foods that only offer immediate satiety and gratification. The Recipe 4 Success educator, pediatrician, or any community educator can give recommendations about which fresh produce may be inexpensive, but nutritional,” Dr. Beard suggested.
Dr. Nix and colleagues as well as Dr. Beard had no conflicts of interest and no relevant financial disclosures.
FROM PEDIATRICS
Further warning on SGLT2 inhibitor use and DKA risk in COVID-19
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
COVID-19 in children: Latest weekly increase is largest yet
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
Schools, COVID-19, and Jan. 6, 2021
The first weeks of 2021 have us considering how best to face compound challenges and we expect parents will be looking to their pediatricians for guidance. There are daily stories of the COVID-19 death toll, an abstraction made real by tragic stories of shattered families. Most families are approaching the first anniversary of their children being in virtual school, with growing concerns about the quality of virtual education, loss of socialization and group activities, and additional risks facing poor and vulnerable children. There are real concerns about the future impact of children spending so much time every day on their screens for school, extracurricular activities, social time, and relaxation. While the COVID-19 vaccines promise a return to “normal” sometime in 2021, in-person school may not return until late in the spring or next fall.
After the events of Jan. 6, families face an additional challenge: Discussing the violent invasion of the U.S. Capitol by the president’s supporters. This event was shocking, frightening, and confusing for most, and continues to be heavily covered in the news and online. There is a light in all this darkness. We have the opportunity to talk with our children – and to share explanations, perspectives, values, and even the discomfort of the unknowns – about COVID-19, use of the Internet, and the violence of Jan 6. We will consider how parents can approach this challenge for three age groups. With each group, parents will need to be calm and curious and will need time to give their children their full attention. We are all living through history. When parents can be fully present with their children, even for short periods at meals or at bedtime, it will help all to get their balance back and start to make sense of the extraordinary events we have been facing.
The youngest children (aged 3-6 years), those who were in preschool or kindergarten before the pandemic, need the most from their parents during this time. If they are attending school virtually, their online school days are likely short and challenging. Children at this age are mastering behavior rather than cognitive tasks. They are learning how to manage their bodies in space (stay in their seats!), how to be patient and kind (take turns!), and how to manage frustration (math is hard, try again!). Without the physical presence of their teacher and classmates, these lessons are tougher to internalize. Given their age-appropriate short attention spans, they often walk away from a screen, even if it’s class time. They are more likely to be paying attention to their parents, responding to the emotional climate at home. Even if they are not watching news websites themselves, they are likely to have overheard or noticed the news about recent events. Parents of young children should take care to turn off the television or their own computer, as repeated frightening videos of the insurrection can cause their children to worry that these events continue to unfold. These children need their parents’ undivided attention, even just for a little while. Play a board game with them (good chance to stay in their seats, take turns, and manage losing). Or get them outside for some physical play. While playing, parents can ask what they have seen, heard, or understand about what happened in the Capitol. Then they can correct misperceptions that might be frightening and offer reasonable reassurances in language these young children can understand. They might tell their children that sometimes people get angry when they have lost, and even adults can behave badly and make mistakes. They can focus on who the helpers are, and what they could do to help also. They could write letters of appreciation to their elected officials or to the Capitol police who were so brave in protecting others. If their children are curious, parents can find books or videos that are age appropriate about the Constitution and how elections work in a democracy. Parents don’t need to be able to answer every question, watching “Schoolhouse Rock” videos on YouTube together is a wonderful way to complement their online school and support their healthy development.
School-aged children (7-12 years) are developmentally focused on mastery experiences, whether they are social, academic, or athletic. They may be better equipped to pay attention and do homework than their younger siblings, but they will miss building friendships and having a real audience for their efforts as they build emotional maturity. They are prone to worry and distress about the big events that they can understand, at least in concrete terms, but have never faced before. These children usually have been able to use social media and online games to stay connected to friends, but they are less likely than their older siblings to independently exercise or explore new interests without a parent or teacher to guide and support them. These children are likely to be spending a lot of their time online on websites their parents don’t know about, and most likely to be curious about the events of Jan. 6. Parents should close their own device and invite their school-age children to show them what they are working on in school. Be curious about all of it, even how they are doing gym or music class. Then ask about what they have seen or heard about the election and its aftermath at school, from friends, or on their own. Let them be the teachers about what happened and how they learned about it. Parents can correct misinformation or offer reliable sources of information they can investigate together. What they will need is validation of the difficult feelings that events like these can cause; that is, acknowledgment, acceptance, and understanding of big feelings, without trying to just make those feelings go away. Parents might help them to be curious about what can make people get angry, break laws, and even hurt others, and how we protest injustices in a democracy. These children may be ready to take a deeper dive into history, via a good film or documentary, with their parents’ company for discussion afterward. Be their audience and model curiosity and patience, all the while validating the feelings that might arise.
Teenagers are developmentally focused on building their own identities, cultivating independence, and deeper relationships beyond their family. While they may be well equipped to manage online learning and to stay connected to their friends and teachers through electronic means, they are also facing considerable challenge, as their ability to explore new interests, build new relationships, and be meaningfully independent has been profoundly restrained over the past year. And they are facing other losses, as milestones like proms, performances, and competitions have been altered or missed. Parents still know when their teenager is most likely to talk, and they should check in with them during those times. They can ask them about what classes are working online and which ones aren’t, and what extracurriculars are still possible. They should not be discouraged if their teenager only offers cursory responses, it matters that they are showing up and showing interest. The election and its aftermath provide a meaningful matter to discuss; parents can find out if it is being discussed by any teachers or friends. What do they think triggered the events of Jan. 6? Who should be held responsible? How to reasonably protest injustice? What does a society do when citizens can’t agree on facts? More than offering reassurance, parents should be curious about their adolescent’s developing identity and their values, how they are thinking about complex issues around free speech and justice. It is a wonderful opportunity for parents to learn about their adolescent’s emerging identity, to be tolerant of their autonomy, and an opportunity to offer their perspective and values.
At every age, parents need to be present by listening and drawing their children out without distraction. Now is a time to build relationships and to use the difficult events of the day to shed light on deeper issues and values. This is hard, but far better than having children deal with these issues in darkness or alone.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
The first weeks of 2021 have us considering how best to face compound challenges and we expect parents will be looking to their pediatricians for guidance. There are daily stories of the COVID-19 death toll, an abstraction made real by tragic stories of shattered families. Most families are approaching the first anniversary of their children being in virtual school, with growing concerns about the quality of virtual education, loss of socialization and group activities, and additional risks facing poor and vulnerable children. There are real concerns about the future impact of children spending so much time every day on their screens for school, extracurricular activities, social time, and relaxation. While the COVID-19 vaccines promise a return to “normal” sometime in 2021, in-person school may not return until late in the spring or next fall.
After the events of Jan. 6, families face an additional challenge: Discussing the violent invasion of the U.S. Capitol by the president’s supporters. This event was shocking, frightening, and confusing for most, and continues to be heavily covered in the news and online. There is a light in all this darkness. We have the opportunity to talk with our children – and to share explanations, perspectives, values, and even the discomfort of the unknowns – about COVID-19, use of the Internet, and the violence of Jan 6. We will consider how parents can approach this challenge for three age groups. With each group, parents will need to be calm and curious and will need time to give their children their full attention. We are all living through history. When parents can be fully present with their children, even for short periods at meals or at bedtime, it will help all to get their balance back and start to make sense of the extraordinary events we have been facing.
The youngest children (aged 3-6 years), those who were in preschool or kindergarten before the pandemic, need the most from their parents during this time. If they are attending school virtually, their online school days are likely short and challenging. Children at this age are mastering behavior rather than cognitive tasks. They are learning how to manage their bodies in space (stay in their seats!), how to be patient and kind (take turns!), and how to manage frustration (math is hard, try again!). Without the physical presence of their teacher and classmates, these lessons are tougher to internalize. Given their age-appropriate short attention spans, they often walk away from a screen, even if it’s class time. They are more likely to be paying attention to their parents, responding to the emotional climate at home. Even if they are not watching news websites themselves, they are likely to have overheard or noticed the news about recent events. Parents of young children should take care to turn off the television or their own computer, as repeated frightening videos of the insurrection can cause their children to worry that these events continue to unfold. These children need their parents’ undivided attention, even just for a little while. Play a board game with them (good chance to stay in their seats, take turns, and manage losing). Or get them outside for some physical play. While playing, parents can ask what they have seen, heard, or understand about what happened in the Capitol. Then they can correct misperceptions that might be frightening and offer reasonable reassurances in language these young children can understand. They might tell their children that sometimes people get angry when they have lost, and even adults can behave badly and make mistakes. They can focus on who the helpers are, and what they could do to help also. They could write letters of appreciation to their elected officials or to the Capitol police who were so brave in protecting others. If their children are curious, parents can find books or videos that are age appropriate about the Constitution and how elections work in a democracy. Parents don’t need to be able to answer every question, watching “Schoolhouse Rock” videos on YouTube together is a wonderful way to complement their online school and support their healthy development.
School-aged children (7-12 years) are developmentally focused on mastery experiences, whether they are social, academic, or athletic. They may be better equipped to pay attention and do homework than their younger siblings, but they will miss building friendships and having a real audience for their efforts as they build emotional maturity. They are prone to worry and distress about the big events that they can understand, at least in concrete terms, but have never faced before. These children usually have been able to use social media and online games to stay connected to friends, but they are less likely than their older siblings to independently exercise or explore new interests without a parent or teacher to guide and support them. These children are likely to be spending a lot of their time online on websites their parents don’t know about, and most likely to be curious about the events of Jan. 6. Parents should close their own device and invite their school-age children to show them what they are working on in school. Be curious about all of it, even how they are doing gym or music class. Then ask about what they have seen or heard about the election and its aftermath at school, from friends, or on their own. Let them be the teachers about what happened and how they learned about it. Parents can correct misinformation or offer reliable sources of information they can investigate together. What they will need is validation of the difficult feelings that events like these can cause; that is, acknowledgment, acceptance, and understanding of big feelings, without trying to just make those feelings go away. Parents might help them to be curious about what can make people get angry, break laws, and even hurt others, and how we protest injustices in a democracy. These children may be ready to take a deeper dive into history, via a good film or documentary, with their parents’ company for discussion afterward. Be their audience and model curiosity and patience, all the while validating the feelings that might arise.
Teenagers are developmentally focused on building their own identities, cultivating independence, and deeper relationships beyond their family. While they may be well equipped to manage online learning and to stay connected to their friends and teachers through electronic means, they are also facing considerable challenge, as their ability to explore new interests, build new relationships, and be meaningfully independent has been profoundly restrained over the past year. And they are facing other losses, as milestones like proms, performances, and competitions have been altered or missed. Parents still know when their teenager is most likely to talk, and they should check in with them during those times. They can ask them about what classes are working online and which ones aren’t, and what extracurriculars are still possible. They should not be discouraged if their teenager only offers cursory responses, it matters that they are showing up and showing interest. The election and its aftermath provide a meaningful matter to discuss; parents can find out if it is being discussed by any teachers or friends. What do they think triggered the events of Jan. 6? Who should be held responsible? How to reasonably protest injustice? What does a society do when citizens can’t agree on facts? More than offering reassurance, parents should be curious about their adolescent’s developing identity and their values, how they are thinking about complex issues around free speech and justice. It is a wonderful opportunity for parents to learn about their adolescent’s emerging identity, to be tolerant of their autonomy, and an opportunity to offer their perspective and values.
At every age, parents need to be present by listening and drawing their children out without distraction. Now is a time to build relationships and to use the difficult events of the day to shed light on deeper issues and values. This is hard, but far better than having children deal with these issues in darkness or alone.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
The first weeks of 2021 have us considering how best to face compound challenges and we expect parents will be looking to their pediatricians for guidance. There are daily stories of the COVID-19 death toll, an abstraction made real by tragic stories of shattered families. Most families are approaching the first anniversary of their children being in virtual school, with growing concerns about the quality of virtual education, loss of socialization and group activities, and additional risks facing poor and vulnerable children. There are real concerns about the future impact of children spending so much time every day on their screens for school, extracurricular activities, social time, and relaxation. While the COVID-19 vaccines promise a return to “normal” sometime in 2021, in-person school may not return until late in the spring or next fall.
After the events of Jan. 6, families face an additional challenge: Discussing the violent invasion of the U.S. Capitol by the president’s supporters. This event was shocking, frightening, and confusing for most, and continues to be heavily covered in the news and online. There is a light in all this darkness. We have the opportunity to talk with our children – and to share explanations, perspectives, values, and even the discomfort of the unknowns – about COVID-19, use of the Internet, and the violence of Jan 6. We will consider how parents can approach this challenge for three age groups. With each group, parents will need to be calm and curious and will need time to give their children their full attention. We are all living through history. When parents can be fully present with their children, even for short periods at meals or at bedtime, it will help all to get their balance back and start to make sense of the extraordinary events we have been facing.
The youngest children (aged 3-6 years), those who were in preschool or kindergarten before the pandemic, need the most from their parents during this time. If they are attending school virtually, their online school days are likely short and challenging. Children at this age are mastering behavior rather than cognitive tasks. They are learning how to manage their bodies in space (stay in their seats!), how to be patient and kind (take turns!), and how to manage frustration (math is hard, try again!). Without the physical presence of their teacher and classmates, these lessons are tougher to internalize. Given their age-appropriate short attention spans, they often walk away from a screen, even if it’s class time. They are more likely to be paying attention to their parents, responding to the emotional climate at home. Even if they are not watching news websites themselves, they are likely to have overheard or noticed the news about recent events. Parents of young children should take care to turn off the television or their own computer, as repeated frightening videos of the insurrection can cause their children to worry that these events continue to unfold. These children need their parents’ undivided attention, even just for a little while. Play a board game with them (good chance to stay in their seats, take turns, and manage losing). Or get them outside for some physical play. While playing, parents can ask what they have seen, heard, or understand about what happened in the Capitol. Then they can correct misperceptions that might be frightening and offer reasonable reassurances in language these young children can understand. They might tell their children that sometimes people get angry when they have lost, and even adults can behave badly and make mistakes. They can focus on who the helpers are, and what they could do to help also. They could write letters of appreciation to their elected officials or to the Capitol police who were so brave in protecting others. If their children are curious, parents can find books or videos that are age appropriate about the Constitution and how elections work in a democracy. Parents don’t need to be able to answer every question, watching “Schoolhouse Rock” videos on YouTube together is a wonderful way to complement their online school and support their healthy development.
School-aged children (7-12 years) are developmentally focused on mastery experiences, whether they are social, academic, or athletic. They may be better equipped to pay attention and do homework than their younger siblings, but they will miss building friendships and having a real audience for their efforts as they build emotional maturity. They are prone to worry and distress about the big events that they can understand, at least in concrete terms, but have never faced before. These children usually have been able to use social media and online games to stay connected to friends, but they are less likely than their older siblings to independently exercise or explore new interests without a parent or teacher to guide and support them. These children are likely to be spending a lot of their time online on websites their parents don’t know about, and most likely to be curious about the events of Jan. 6. Parents should close their own device and invite their school-age children to show them what they are working on in school. Be curious about all of it, even how they are doing gym or music class. Then ask about what they have seen or heard about the election and its aftermath at school, from friends, or on their own. Let them be the teachers about what happened and how they learned about it. Parents can correct misinformation or offer reliable sources of information they can investigate together. What they will need is validation of the difficult feelings that events like these can cause; that is, acknowledgment, acceptance, and understanding of big feelings, without trying to just make those feelings go away. Parents might help them to be curious about what can make people get angry, break laws, and even hurt others, and how we protest injustices in a democracy. These children may be ready to take a deeper dive into history, via a good film or documentary, with their parents’ company for discussion afterward. Be their audience and model curiosity and patience, all the while validating the feelings that might arise.
Teenagers are developmentally focused on building their own identities, cultivating independence, and deeper relationships beyond their family. While they may be well equipped to manage online learning and to stay connected to their friends and teachers through electronic means, they are also facing considerable challenge, as their ability to explore new interests, build new relationships, and be meaningfully independent has been profoundly restrained over the past year. And they are facing other losses, as milestones like proms, performances, and competitions have been altered or missed. Parents still know when their teenager is most likely to talk, and they should check in with them during those times. They can ask them about what classes are working online and which ones aren’t, and what extracurriculars are still possible. They should not be discouraged if their teenager only offers cursory responses, it matters that they are showing up and showing interest. The election and its aftermath provide a meaningful matter to discuss; parents can find out if it is being discussed by any teachers or friends. What do they think triggered the events of Jan. 6? Who should be held responsible? How to reasonably protest injustice? What does a society do when citizens can’t agree on facts? More than offering reassurance, parents should be curious about their adolescent’s developing identity and their values, how they are thinking about complex issues around free speech and justice. It is a wonderful opportunity for parents to learn about their adolescent’s emerging identity, to be tolerant of their autonomy, and an opportunity to offer their perspective and values.
At every age, parents need to be present by listening and drawing their children out without distraction. Now is a time to build relationships and to use the difficult events of the day to shed light on deeper issues and values. This is hard, but far better than having children deal with these issues in darkness or alone.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. Email them at pdnews@mdedge.com.