Pediatric News

The Food and Drug Administration has approved the interleukin-17 inhibitor secukinumab (Cosentyx) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.

Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.

The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”

The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.

At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.

Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.

The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.

“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”

Dr. Cordoro reported having no financial disclosures.

[email protected]

The Food and Drug Administration has approved the interleukin-17 inhibitor secukinumab (Cosentyx) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.

Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.

The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”

The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.

At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.

Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.

The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.

“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”

Dr. Cordoro reported having no financial disclosures.

[email protected]

The Food and Drug Administration has approved the interleukin-17 inhibitor secukinumab (Cosentyx) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.

Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.

The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”

The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.

At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.

Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.

The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.

“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”

Dr. Cordoro reported having no financial disclosures.

[email protected]

The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has petitioned the Food and Drug Administration to recall 40 batches of sunscreens and after-sun products they say tested for high levels of the chemical benzene.

The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.

Long-term exposure to benzene is known to cause cancer in humans.

“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.

The FDA is seeking more information about the potential risks from common sunscreen ingredients.

“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
 

Examining sunscreen’s environmental impact

Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.

Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.

Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”

Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.

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

Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has petitioned the Food and Drug Administration to recall 40 batches of sunscreens and after-sun products they say tested for high levels of the chemical benzene.

The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.

Long-term exposure to benzene is known to cause cancer in humans.

“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.

The FDA is seeking more information about the potential risks from common sunscreen ingredients.

“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
 

Examining sunscreen’s environmental impact

Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.

Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.

Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”

Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.

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

Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has petitioned the Food and Drug Administration to recall 40 batches of sunscreens and after-sun products they say tested for high levels of the chemical benzene.

The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.

Long-term exposure to benzene is known to cause cancer in humans.

“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.

The FDA is seeking more information about the potential risks from common sunscreen ingredients.

“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
 

Examining sunscreen’s environmental impact

Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.

Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.

Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”

Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.

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

Burnout is seldom the result of a single factor. It is more often a tragic case of death by a thousand cuts: a balky user-unfriendly electronic medical record system, administrative pressure to see more patients and the resulting frustration of not being able to provide the care you feel they deserve, an overemphasis on documentation or you won’t get paid, the dark cloud of malpractice always overhead, and of course the difficult balance between family responsibilities and work. It often boils down to feeling that there aren’t enough hours in the day to get everything done and still have time to recharge your physical and psychological batteries.

A recent report in the Harvard Business School newsletter, Working Knowledge (“Commuting Hurts Productivity and Your Best Talent Suffers Most.” Lane Lambert. 2021 Mar 30) describes an interesting study by Andy Wu, assistant professor of business administration, in which he discovered that, for every 10 kilometers of commuting distance, there was a decrease in the productivity of high-tech inventors as measured by the number of patents registered by their companies. The quality of their inventions declined even more (7%) for each additional 10 kilometers of commute.

You might question the relevance of these findings with your work in an outpatient clinic, but a conscientious physician is also an inventor and a creator. Every patient, even those with what sounds like a routine complaint, presents a novel collection of management challenges. The best physicians treat their profession as an art and must be invent solutions on the fly.

There is abundant evidence that commuting also can have a negative effect on the physical and mental health of workers. (“The astonishing human potential wasted on commutes.” The Washington Post .Christopher Ingraham. 2016 Feb 25). Watching my father walk into the house after an hour-long train ride out of the city and listening to him grumble created an image that influenced every decision I made about where my wife and I would live and work.

Did I benefit from the luxury of growing up in a small suburban community? Of course I did and I shall be forever grateful for the sacrifice my father made to allow that to happen. But, I promised myself that, while I would make sacrifices for my family, a long or unpleasant commute was not going to be on that list. For a few years I tolerated a 10- to 12-minute car commute (three stoplights) but asked to dissolve the partnership because even that 9-mile ride was too much for me and instead spent the bulk of my 40-year career a 10-minute bike ride from my office and the two hospitals. It meant we didn’t have a view of the ocean or a gentleman’s farm but we had an extra hour together as a family and I arrived at work and at home happy.

The pandemic has been a wake-up call for many of the fortunate folks who have found that they can work from home, eliminating what may have been a time-gobbling commute that was creating more stress than they may have realized. Even if telemedicine continues to maintain some postpandemic presence, I suspect that most physicians will continue to be faced with the challenge of traveling to an office or hospital.

If work is losing some of its luster and/or you are arriving home grumpy from a long day in the office, it is easy to blame an insensitive office administrator or the clunky electronic medical record system ... they deserve it. But, it may be the journey and not just the destination that is the contributing to the problem. I realize that rethinking the decision about where one lives can be painful and the options may be limited. However, I hope that at least some of you can rethink the role your journey is playing in your life.

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 [email protected].

Burnout is seldom the result of a single factor. It is more often a tragic case of death by a thousand cuts: a balky user-unfriendly electronic medical record system, administrative pressure to see more patients and the resulting frustration of not being able to provide the care you feel they deserve, an overemphasis on documentation or you won’t get paid, the dark cloud of malpractice always overhead, and of course the difficult balance between family responsibilities and work. It often boils down to feeling that there aren’t enough hours in the day to get everything done and still have time to recharge your physical and psychological batteries.

A recent report in the Harvard Business School newsletter, Working Knowledge (“Commuting Hurts Productivity and Your Best Talent Suffers Most.” Lane Lambert. 2021 Mar 30) describes an interesting study by Andy Wu, assistant professor of business administration, in which he discovered that, for every 10 kilometers of commuting distance, there was a decrease in the productivity of high-tech inventors as measured by the number of patents registered by their companies. The quality of their inventions declined even more (7%) for each additional 10 kilometers of commute.

You might question the relevance of these findings with your work in an outpatient clinic, but a conscientious physician is also an inventor and a creator. Every patient, even those with what sounds like a routine complaint, presents a novel collection of management challenges. The best physicians treat their profession as an art and must be invent solutions on the fly.

There is abundant evidence that commuting also can have a negative effect on the physical and mental health of workers. (“The astonishing human potential wasted on commutes.” The Washington Post .Christopher Ingraham. 2016 Feb 25). Watching my father walk into the house after an hour-long train ride out of the city and listening to him grumble created an image that influenced every decision I made about where my wife and I would live and work.

Did I benefit from the luxury of growing up in a small suburban community? Of course I did and I shall be forever grateful for the sacrifice my father made to allow that to happen. But, I promised myself that, while I would make sacrifices for my family, a long or unpleasant commute was not going to be on that list. For a few years I tolerated a 10- to 12-minute car commute (three stoplights) but asked to dissolve the partnership because even that 9-mile ride was too much for me and instead spent the bulk of my 40-year career a 10-minute bike ride from my office and the two hospitals. It meant we didn’t have a view of the ocean or a gentleman’s farm but we had an extra hour together as a family and I arrived at work and at home happy.

The pandemic has been a wake-up call for many of the fortunate folks who have found that they can work from home, eliminating what may have been a time-gobbling commute that was creating more stress than they may have realized. Even if telemedicine continues to maintain some postpandemic presence, I suspect that most physicians will continue to be faced with the challenge of traveling to an office or hospital.

If work is losing some of its luster and/or you are arriving home grumpy from a long day in the office, it is easy to blame an insensitive office administrator or the clunky electronic medical record system ... they deserve it. But, it may be the journey and not just the destination that is the contributing to the problem. I realize that rethinking the decision about where one lives can be painful and the options may be limited. However, I hope that at least some of you can rethink the role your journey is playing in your life.

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 [email protected].

Burnout is seldom the result of a single factor. It is more often a tragic case of death by a thousand cuts: a balky user-unfriendly electronic medical record system, administrative pressure to see more patients and the resulting frustration of not being able to provide the care you feel they deserve, an overemphasis on documentation or you won’t get paid, the dark cloud of malpractice always overhead, and of course the difficult balance between family responsibilities and work. It often boils down to feeling that there aren’t enough hours in the day to get everything done and still have time to recharge your physical and psychological batteries.

A recent report in the Harvard Business School newsletter, Working Knowledge (“Commuting Hurts Productivity and Your Best Talent Suffers Most.” Lane Lambert. 2021 Mar 30) describes an interesting study by Andy Wu, assistant professor of business administration, in which he discovered that, for every 10 kilometers of commuting distance, there was a decrease in the productivity of high-tech inventors as measured by the number of patents registered by their companies. The quality of their inventions declined even more (7%) for each additional 10 kilometers of commute.

You might question the relevance of these findings with your work in an outpatient clinic, but a conscientious physician is also an inventor and a creator. Every patient, even those with what sounds like a routine complaint, presents a novel collection of management challenges. The best physicians treat their profession as an art and must be invent solutions on the fly.

There is abundant evidence that commuting also can have a negative effect on the physical and mental health of workers. (“The astonishing human potential wasted on commutes.” The Washington Post .Christopher Ingraham. 2016 Feb 25). Watching my father walk into the house after an hour-long train ride out of the city and listening to him grumble created an image that influenced every decision I made about where my wife and I would live and work.

Did I benefit from the luxury of growing up in a small suburban community? Of course I did and I shall be forever grateful for the sacrifice my father made to allow that to happen. But, I promised myself that, while I would make sacrifices for my family, a long or unpleasant commute was not going to be on that list. For a few years I tolerated a 10- to 12-minute car commute (three stoplights) but asked to dissolve the partnership because even that 9-mile ride was too much for me and instead spent the bulk of my 40-year career a 10-minute bike ride from my office and the two hospitals. It meant we didn’t have a view of the ocean or a gentleman’s farm but we had an extra hour together as a family and I arrived at work and at home happy.

The pandemic has been a wake-up call for many of the fortunate folks who have found that they can work from home, eliminating what may have been a time-gobbling commute that was creating more stress than they may have realized. Even if telemedicine continues to maintain some postpandemic presence, I suspect that most physicians will continue to be faced with the challenge of traveling to an office or hospital.

If work is losing some of its luster and/or you are arriving home grumpy from a long day in the office, it is easy to blame an insensitive office administrator or the clunky electronic medical record system ... they deserve it. But, it may be the journey and not just the destination that is the contributing to the problem. I realize that rethinking the decision about where one lives can be painful and the options may be limited. However, I hope that at least some of you can rethink the role your journey is playing in your life.

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 [email protected].

In the periurban slum of Lusaka, Zambia, asymptomatic pertussis infections were common among both mothers and infants, a surprising finding since asymptomatic infections are assumed to be rare in infants. The findings suggested that pertussis should be considered in cases of chronic cough, and that current standards of treating pertussis infections in low-resource settings may need to be reexamined.

The results come from testing of 1,320 infant-mother pairs who were first enrolled at a public health clinic, then followed over at least four visits. The researchers tracked pertussis infection using quantitative PCR (qPCR) on nasopharyngeal swabs. Over the course of the study, 8.9% tested positive, although only one infant developed clinical pertussis during the study.

The study was presented by Christian Gunning, a postdoctoral researcher at the University of Georgia, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. The group also included researchers at Boston University and the University of Zambia, where PCR tests were conducted.

“That was amazing,” said session moderator Vana Spoulou, MD, PhD, professor of pediatric infectious diseases at National and Kapodistrian University of Athens, who is associated with Aghia Sofia Children’s Hospital of Athens. She noted that the study found that many physicians misdiagnosed coughs, believing them to be caused by another agent. “It was very interesting that there was so much pertussis spreading around in that community, and that nobody knew that it was around,” said Dr. Spoulou.

It’s important that physicians provide appropriate treatment, since ampicillin, which is typically prescribed for childhood upper respiratory illnesses, is believed to be ineffective against pertussis, while macrolides are effective and can prevent transmission.

Dr. Spoulou also noted that Zambia uses a whole cell vaccine, which is contraindicated in pregnant women because of potential side effects. “The good thing, despite that there was [a lot of] infection, there were no deaths, which means that maybe because the mother was infected, maybe some antibodies of the mother had passed to the child and could help the child to develop milder symptoms. So these are the pros and cons of natural infection,” said Dr. Spoulou.

The study took place in 2015, and participants were seen at the Chawama Public Health Clinic from about age 1 week to 4 months (with a target of seven clinic visits). Researchers recorded respiratory symptoms and antibiotics use at each visit, and collected a nasopharyngeal swab that was tested retrospectively using qPCR for Bordetella pertussis.

Real-time PCR analysis of the samples yields the CT value, which represents the number of amplification cycles that the PCR test must complete before Bordetella pertussis is detectable. The fewer the cycles (and the lower the CT value), the more infectious particles must have been present in the sample. For pertussis testing, a value below 35 is considered a clinically positive result. Tests that come back with higher CT values are increasingly likely to be false positives.

The researchers plotted a value called evidence for infection (EFI), which combined a range of CT values with the number of positive tests over the seven clinic visits to group patients into none, weak, or strong EFI. Among infants with no symptoms, 77% were in the no EFI category, 16% were in the weak category, and 7% were in the strong EFI group. Of infants with minimal respiratory symptoms, 18% were in the strong group, and 20% with moderate to severe symptoms were in the strong EFI group. Among mothers, 13% with no symptoms were in the strong group. 19% in the minimal symptom group were categorized as strong EFI, as were 11% in the moderate to severe symptom group.

The study used a full range of CT, not just positive test results (for pertussis, CT ≤ 35). Beyond contributing to composite measures such as EFI, CT values can serve as leading indicators of infectious disease outbreaks in a population, according to Dr. Gunning. That’s because weaker qPCR signals (CT > 35) can provide additional information within a large sample population. Higher CT values are successively more prone to false positives, but that’s less important for disease surveillance where sensitivity is of the highest importance. The false positive “noise” tends to cancel out over time. “It may be the case that you don’t make that call (correctly) 100% of the time for 100% of the people, but if you get it right in 80 out of 100 people, that’s sufficient to say we see this pathogen circulating in the population,” said Dr. Gunning.

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Gunning and Dr. Spoulou have no relevant financial disclosures.

In the periurban slum of Lusaka, Zambia, asymptomatic pertussis infections were common among both mothers and infants, a surprising finding since asymptomatic infections are assumed to be rare in infants. The findings suggested that pertussis should be considered in cases of chronic cough, and that current standards of treating pertussis infections in low-resource settings may need to be reexamined.

The results come from testing of 1,320 infant-mother pairs who were first enrolled at a public health clinic, then followed over at least four visits. The researchers tracked pertussis infection using quantitative PCR (qPCR) on nasopharyngeal swabs. Over the course of the study, 8.9% tested positive, although only one infant developed clinical pertussis during the study.

The study was presented by Christian Gunning, a postdoctoral researcher at the University of Georgia, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. The group also included researchers at Boston University and the University of Zambia, where PCR tests were conducted.

“That was amazing,” said session moderator Vana Spoulou, MD, PhD, professor of pediatric infectious diseases at National and Kapodistrian University of Athens, who is associated with Aghia Sofia Children’s Hospital of Athens. She noted that the study found that many physicians misdiagnosed coughs, believing them to be caused by another agent. “It was very interesting that there was so much pertussis spreading around in that community, and that nobody knew that it was around,” said Dr. Spoulou.

It’s important that physicians provide appropriate treatment, since ampicillin, which is typically prescribed for childhood upper respiratory illnesses, is believed to be ineffective against pertussis, while macrolides are effective and can prevent transmission.

Dr. Spoulou also noted that Zambia uses a whole cell vaccine, which is contraindicated in pregnant women because of potential side effects. “The good thing, despite that there was [a lot of] infection, there were no deaths, which means that maybe because the mother was infected, maybe some antibodies of the mother had passed to the child and could help the child to develop milder symptoms. So these are the pros and cons of natural infection,” said Dr. Spoulou.

The study took place in 2015, and participants were seen at the Chawama Public Health Clinic from about age 1 week to 4 months (with a target of seven clinic visits). Researchers recorded respiratory symptoms and antibiotics use at each visit, and collected a nasopharyngeal swab that was tested retrospectively using qPCR for Bordetella pertussis.

Real-time PCR analysis of the samples yields the CT value, which represents the number of amplification cycles that the PCR test must complete before Bordetella pertussis is detectable. The fewer the cycles (and the lower the CT value), the more infectious particles must have been present in the sample. For pertussis testing, a value below 35 is considered a clinically positive result. Tests that come back with higher CT values are increasingly likely to be false positives.

The researchers plotted a value called evidence for infection (EFI), which combined a range of CT values with the number of positive tests over the seven clinic visits to group patients into none, weak, or strong EFI. Among infants with no symptoms, 77% were in the no EFI category, 16% were in the weak category, and 7% were in the strong EFI group. Of infants with minimal respiratory symptoms, 18% were in the strong group, and 20% with moderate to severe symptoms were in the strong EFI group. Among mothers, 13% with no symptoms were in the strong group. 19% in the minimal symptom group were categorized as strong EFI, as were 11% in the moderate to severe symptom group.

The study used a full range of CT, not just positive test results (for pertussis, CT ≤ 35). Beyond contributing to composite measures such as EFI, CT values can serve as leading indicators of infectious disease outbreaks in a population, according to Dr. Gunning. That’s because weaker qPCR signals (CT > 35) can provide additional information within a large sample population. Higher CT values are successively more prone to false positives, but that’s less important for disease surveillance where sensitivity is of the highest importance. The false positive “noise” tends to cancel out over time. “It may be the case that you don’t make that call (correctly) 100% of the time for 100% of the people, but if you get it right in 80 out of 100 people, that’s sufficient to say we see this pathogen circulating in the population,” said Dr. Gunning.

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Gunning and Dr. Spoulou have no relevant financial disclosures.

In the periurban slum of Lusaka, Zambia, asymptomatic pertussis infections were common among both mothers and infants, a surprising finding since asymptomatic infections are assumed to be rare in infants. The findings suggested that pertussis should be considered in cases of chronic cough, and that current standards of treating pertussis infections in low-resource settings may need to be reexamined.

The results come from testing of 1,320 infant-mother pairs who were first enrolled at a public health clinic, then followed over at least four visits. The researchers tracked pertussis infection using quantitative PCR (qPCR) on nasopharyngeal swabs. Over the course of the study, 8.9% tested positive, although only one infant developed clinical pertussis during the study.

The study was presented by Christian Gunning, a postdoctoral researcher at the University of Georgia, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. The group also included researchers at Boston University and the University of Zambia, where PCR tests were conducted.

“That was amazing,” said session moderator Vana Spoulou, MD, PhD, professor of pediatric infectious diseases at National and Kapodistrian University of Athens, who is associated with Aghia Sofia Children’s Hospital of Athens. She noted that the study found that many physicians misdiagnosed coughs, believing them to be caused by another agent. “It was very interesting that there was so much pertussis spreading around in that community, and that nobody knew that it was around,” said Dr. Spoulou.

It’s important that physicians provide appropriate treatment, since ampicillin, which is typically prescribed for childhood upper respiratory illnesses, is believed to be ineffective against pertussis, while macrolides are effective and can prevent transmission.

Dr. Spoulou also noted that Zambia uses a whole cell vaccine, which is contraindicated in pregnant women because of potential side effects. “The good thing, despite that there was [a lot of] infection, there were no deaths, which means that maybe because the mother was infected, maybe some antibodies of the mother had passed to the child and could help the child to develop milder symptoms. So these are the pros and cons of natural infection,” said Dr. Spoulou.

The study took place in 2015, and participants were seen at the Chawama Public Health Clinic from about age 1 week to 4 months (with a target of seven clinic visits). Researchers recorded respiratory symptoms and antibiotics use at each visit, and collected a nasopharyngeal swab that was tested retrospectively using qPCR for Bordetella pertussis.

Real-time PCR analysis of the samples yields the CT value, which represents the number of amplification cycles that the PCR test must complete before Bordetella pertussis is detectable. The fewer the cycles (and the lower the CT value), the more infectious particles must have been present in the sample. For pertussis testing, a value below 35 is considered a clinically positive result. Tests that come back with higher CT values are increasingly likely to be false positives.

The researchers plotted a value called evidence for infection (EFI), which combined a range of CT values with the number of positive tests over the seven clinic visits to group patients into none, weak, or strong EFI. Among infants with no symptoms, 77% were in the no EFI category, 16% were in the weak category, and 7% were in the strong EFI group. Of infants with minimal respiratory symptoms, 18% were in the strong group, and 20% with moderate to severe symptoms were in the strong EFI group. Among mothers, 13% with no symptoms were in the strong group. 19% in the minimal symptom group were categorized as strong EFI, as were 11% in the moderate to severe symptom group.

The study used a full range of CT, not just positive test results (for pertussis, CT ≤ 35). Beyond contributing to composite measures such as EFI, CT values can serve as leading indicators of infectious disease outbreaks in a population, according to Dr. Gunning. That’s because weaker qPCR signals (CT > 35) can provide additional information within a large sample population. Higher CT values are successively more prone to false positives, but that’s less important for disease surveillance where sensitivity is of the highest importance. The false positive “noise” tends to cancel out over time. “It may be the case that you don’t make that call (correctly) 100% of the time for 100% of the people, but if you get it right in 80 out of 100 people, that’s sufficient to say we see this pathogen circulating in the population,” said Dr. Gunning.

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Gunning and Dr. Spoulou have no relevant financial disclosures.

More children aged 12-15 years already have received at least one dose of a COVID-19 vaccine than have 16- and 17-year-olds, based on data from the Centers for Disease Control and Prevention.

As of May 30, almost 2.89 million children aged 12-15 years had received at least one dose, compared with nearly 2.73 million children aged 16-17, with those figures representing increases of 31.6% and 6.6% in the past week, respectively. Since the overall size of the 12-15 population is much larger, however, the proportion vaccinated is still smaller: 19.5% to 36.4%, according to the CDC’s COVID Data Tracker.

A look at full vaccination status shows that only 0.7% of those aged 12-15 years have received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 24% of those aged 16-17. For the country as a whole, 50.5% of all ages have received at least one dose and 40.7% are fully vaccinated, the CDC said.

Children aged 12-15 represent the largest share of the U.S. population (23.4%) initiating vaccination in the 14 days ending May 30, while children aged 16-17 made up just 4.5% of those getting their first dose. The younger group’s later entry into the vaccination pool shows up again when looking at completion rates, though, representing just 0.4% of all Americans who reached full vaccination during that same 14-day period, compared with 4.6% of the older children, the CDC data show.

Not all states are reporting data such as age for vaccine recipients, the CDC noted, and there are other variables that affect data collection. “Demographic data ... might differ by populations prioritized within each state or jurisdiction’s vaccination phase. Every geographic area has a different racial and ethnic composition, and not all are in the same vaccination phase,” the CDC said.

[email protected]

More children aged 12-15 years already have received at least one dose of a COVID-19 vaccine than have 16- and 17-year-olds, based on data from the Centers for Disease Control and Prevention.

As of May 30, almost 2.89 million children aged 12-15 years had received at least one dose, compared with nearly 2.73 million children aged 16-17, with those figures representing increases of 31.6% and 6.6% in the past week, respectively. Since the overall size of the 12-15 population is much larger, however, the proportion vaccinated is still smaller: 19.5% to 36.4%, according to the CDC’s COVID Data Tracker.

A look at full vaccination status shows that only 0.7% of those aged 12-15 years have received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 24% of those aged 16-17. For the country as a whole, 50.5% of all ages have received at least one dose and 40.7% are fully vaccinated, the CDC said.

Children aged 12-15 represent the largest share of the U.S. population (23.4%) initiating vaccination in the 14 days ending May 30, while children aged 16-17 made up just 4.5% of those getting their first dose. The younger group’s later entry into the vaccination pool shows up again when looking at completion rates, though, representing just 0.4% of all Americans who reached full vaccination during that same 14-day period, compared with 4.6% of the older children, the CDC data show.

Not all states are reporting data such as age for vaccine recipients, the CDC noted, and there are other variables that affect data collection. “Demographic data ... might differ by populations prioritized within each state or jurisdiction’s vaccination phase. Every geographic area has a different racial and ethnic composition, and not all are in the same vaccination phase,” the CDC said.

[email protected]

More children aged 12-15 years already have received at least one dose of a COVID-19 vaccine than have 16- and 17-year-olds, based on data from the Centers for Disease Control and Prevention.

As of May 30, almost 2.89 million children aged 12-15 years had received at least one dose, compared with nearly 2.73 million children aged 16-17, with those figures representing increases of 31.6% and 6.6% in the past week, respectively. Since the overall size of the 12-15 population is much larger, however, the proportion vaccinated is still smaller: 19.5% to 36.4%, according to the CDC’s COVID Data Tracker.

A look at full vaccination status shows that only 0.7% of those aged 12-15 years have received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 24% of those aged 16-17. For the country as a whole, 50.5% of all ages have received at least one dose and 40.7% are fully vaccinated, the CDC said.

Children aged 12-15 represent the largest share of the U.S. population (23.4%) initiating vaccination in the 14 days ending May 30, while children aged 16-17 made up just 4.5% of those getting their first dose. The younger group’s later entry into the vaccination pool shows up again when looking at completion rates, though, representing just 0.4% of all Americans who reached full vaccination during that same 14-day period, compared with 4.6% of the older children, the CDC data show.

Not all states are reporting data such as age for vaccine recipients, the CDC noted, and there are other variables that affect data collection. “Demographic data ... might differ by populations prioritized within each state or jurisdiction’s vaccination phase. Every geographic area has a different racial and ethnic composition, and not all are in the same vaccination phase,” the CDC said.

[email protected]

Among children with sickle cell disease who have not undergone hematopoietic stem cell transplant, Salmonella is now the leading cause of invasive bacterial infection (IBI), according to a new retrospective study (BACT-SPRING) conducted in Europe. Streptococcus pneumoniae was the second most common source of infection, marking a shift from years past, when S. pneumoniae was the most common source. The epidemiology of IBI in Europe has been altered by adoption of prophylaxis and the introduction of the pneumococcal conjugated vaccine (PCV13) in 2009.

Previous studies of IBI have been single center with small sample sizes, and few have been conducted since 2016, said Jean Gaschignard, MD, PhD, during his presentation of the study at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Dr. Gaschignard is head of pediatrics at Groupe Hospitalier Nord Essonne in Longjumeau, France.

The study produced some unexpected results. “We were surprised,” said Dr. Gaschignard, by results indicating that not all children aged under 10 years were undergoing prophylaxis. Instead, the figures were closer to 80% or 90%. Among children over 10, the rate of prophylaxis varies between countries. “Our study is a clue to discuss again the indications for the age limit for prophylaxis against pneumococcus,” said Dr. Gauschignard, during the question-and-answer session following his talk.

The data give clinicians an updated picture of the epidemiology in this population following introduction of the PCV13 vaccine. “It was very important to have new data on microbiology after this implementation,” said Marie Rohr, MD, who is a fellow in pediatric infectious diseases at the University Hospitals of Geneva. Dr. Rohr moderated the session where the study was presented.

Dr. Rohr noted the shift from the dominant cause of IBI after the introduction of the PCV10/13 vaccine, from S. pneumoniae to Salmonella. The researchers also found a preponderance of bacteremia and osteoarticular infections. “The mortality and morbidity are still considerable despite infection preventive measures,” said Dr. Rohr.

The results should also prompt a second look at prevention strategies. “Even if the antibiotic prophylaxis is prescribed for a large [proportion of children with sickle cell disease] under 10 years old, the median age of invasive bacterial infection is 7 years old. This calls into question systematic antibiotic prophylaxis and case-control studies are needed to evaluate this and possibly modify antibiotic prophylaxis recommendations in the future,” said Dr. Rohr.

The BACT-SPRING study was conducted between Jan. 1, 2014, and Dec. 31, 2019, using online data. It included 217 IBI episodes from 26 centers in five European countries. Just over half were from France, while about a quarter occurred in Spain. Other countries included Belgium, Portugal, and Great Britain. Participants were younger than 18 and had an IBI confirmed by bacterial culture or PCR from normally sterile fluid.

Thirty-eight episodes occurred in children who had undergone hematopoietic stem cell transplantation (HSCT), and 179 in children who had not undergone HSCT. The presentation focused exclusively on the latter group.

Among episodes in children without HSCT, the mean age was 7. Forty-eight patients had a history of acute chest syndrome, 47 had a history of ICU admission, 29 had a history of IBI, and 27 had a history of acute splenic sequestration. Thirteen underwent a splenectomy. Almost half of children had none of these characteristics, while about one-fourth had two or more.

In the HSCT group, 141 children were on prophylaxis at the time of the infection; 74 were on hydroxyurea, and 36 were currently or previously on a transfusion program. Sixty-eight cases were primary bacteremia and 55 were osteoarticular. Other syndromes included pneumonia empyema (n = 18), and meningitis (n = 17), among others. In 44 cases, the isolated bacteria was Salmonella, followed by S. pneumoniae in 32 cases. Escherichia coli accounted for 22. Haemophilus influenza was identified in six episodes, and group A Streptococcus in three.

The study is the first large European epidemiologic study investigating IBI in children with sickle cell disease, and one of its strengths was the strict inclusion criteria. However, it was limited by its retrospective nature.

Dr. Gaschignard and Dr. Rohr have no relevant financial disclosures.

Among children with sickle cell disease who have not undergone hematopoietic stem cell transplant, Salmonella is now the leading cause of invasive bacterial infection (IBI), according to a new retrospective study (BACT-SPRING) conducted in Europe. Streptococcus pneumoniae was the second most common source of infection, marking a shift from years past, when S. pneumoniae was the most common source. The epidemiology of IBI in Europe has been altered by adoption of prophylaxis and the introduction of the pneumococcal conjugated vaccine (PCV13) in 2009.

Previous studies of IBI have been single center with small sample sizes, and few have been conducted since 2016, said Jean Gaschignard, MD, PhD, during his presentation of the study at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Dr. Gaschignard is head of pediatrics at Groupe Hospitalier Nord Essonne in Longjumeau, France.

The study produced some unexpected results. “We were surprised,” said Dr. Gaschignard, by results indicating that not all children aged under 10 years were undergoing prophylaxis. Instead, the figures were closer to 80% or 90%. Among children over 10, the rate of prophylaxis varies between countries. “Our study is a clue to discuss again the indications for the age limit for prophylaxis against pneumococcus,” said Dr. Gauschignard, during the question-and-answer session following his talk.

The data give clinicians an updated picture of the epidemiology in this population following introduction of the PCV13 vaccine. “It was very important to have new data on microbiology after this implementation,” said Marie Rohr, MD, who is a fellow in pediatric infectious diseases at the University Hospitals of Geneva. Dr. Rohr moderated the session where the study was presented.

Dr. Rohr noted the shift from the dominant cause of IBI after the introduction of the PCV10/13 vaccine, from S. pneumoniae to Salmonella. The researchers also found a preponderance of bacteremia and osteoarticular infections. “The mortality and morbidity are still considerable despite infection preventive measures,” said Dr. Rohr.

The results should also prompt a second look at prevention strategies. “Even if the antibiotic prophylaxis is prescribed for a large [proportion of children with sickle cell disease] under 10 years old, the median age of invasive bacterial infection is 7 years old. This calls into question systematic antibiotic prophylaxis and case-control studies are needed to evaluate this and possibly modify antibiotic prophylaxis recommendations in the future,” said Dr. Rohr.

The BACT-SPRING study was conducted between Jan. 1, 2014, and Dec. 31, 2019, using online data. It included 217 IBI episodes from 26 centers in five European countries. Just over half were from France, while about a quarter occurred in Spain. Other countries included Belgium, Portugal, and Great Britain. Participants were younger than 18 and had an IBI confirmed by bacterial culture or PCR from normally sterile fluid.

Thirty-eight episodes occurred in children who had undergone hematopoietic stem cell transplantation (HSCT), and 179 in children who had not undergone HSCT. The presentation focused exclusively on the latter group.

Among episodes in children without HSCT, the mean age was 7. Forty-eight patients had a history of acute chest syndrome, 47 had a history of ICU admission, 29 had a history of IBI, and 27 had a history of acute splenic sequestration. Thirteen underwent a splenectomy. Almost half of children had none of these characteristics, while about one-fourth had two or more.

In the HSCT group, 141 children were on prophylaxis at the time of the infection; 74 were on hydroxyurea, and 36 were currently or previously on a transfusion program. Sixty-eight cases were primary bacteremia and 55 were osteoarticular. Other syndromes included pneumonia empyema (n = 18), and meningitis (n = 17), among others. In 44 cases, the isolated bacteria was Salmonella, followed by S. pneumoniae in 32 cases. Escherichia coli accounted for 22. Haemophilus influenza was identified in six episodes, and group A Streptococcus in three.

The study is the first large European epidemiologic study investigating IBI in children with sickle cell disease, and one of its strengths was the strict inclusion criteria. However, it was limited by its retrospective nature.

Dr. Gaschignard and Dr. Rohr have no relevant financial disclosures.

Among children with sickle cell disease who have not undergone hematopoietic stem cell transplant, Salmonella is now the leading cause of invasive bacterial infection (IBI), according to a new retrospective study (BACT-SPRING) conducted in Europe. Streptococcus pneumoniae was the second most common source of infection, marking a shift from years past, when S. pneumoniae was the most common source. The epidemiology of IBI in Europe has been altered by adoption of prophylaxis and the introduction of the pneumococcal conjugated vaccine (PCV13) in 2009.

Previous studies of IBI have been single center with small sample sizes, and few have been conducted since 2016, said Jean Gaschignard, MD, PhD, during his presentation of the study at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Dr. Gaschignard is head of pediatrics at Groupe Hospitalier Nord Essonne in Longjumeau, France.

The study produced some unexpected results. “We were surprised,” said Dr. Gaschignard, by results indicating that not all children aged under 10 years were undergoing prophylaxis. Instead, the figures were closer to 80% or 90%. Among children over 10, the rate of prophylaxis varies between countries. “Our study is a clue to discuss again the indications for the age limit for prophylaxis against pneumococcus,” said Dr. Gauschignard, during the question-and-answer session following his talk.

The data give clinicians an updated picture of the epidemiology in this population following introduction of the PCV13 vaccine. “It was very important to have new data on microbiology after this implementation,” said Marie Rohr, MD, who is a fellow in pediatric infectious diseases at the University Hospitals of Geneva. Dr. Rohr moderated the session where the study was presented.

Dr. Rohr noted the shift from the dominant cause of IBI after the introduction of the PCV10/13 vaccine, from S. pneumoniae to Salmonella. The researchers also found a preponderance of bacteremia and osteoarticular infections. “The mortality and morbidity are still considerable despite infection preventive measures,” said Dr. Rohr.

The results should also prompt a second look at prevention strategies. “Even if the antibiotic prophylaxis is prescribed for a large [proportion of children with sickle cell disease] under 10 years old, the median age of invasive bacterial infection is 7 years old. This calls into question systematic antibiotic prophylaxis and case-control studies are needed to evaluate this and possibly modify antibiotic prophylaxis recommendations in the future,” said Dr. Rohr.

The BACT-SPRING study was conducted between Jan. 1, 2014, and Dec. 31, 2019, using online data. It included 217 IBI episodes from 26 centers in five European countries. Just over half were from France, while about a quarter occurred in Spain. Other countries included Belgium, Portugal, and Great Britain. Participants were younger than 18 and had an IBI confirmed by bacterial culture or PCR from normally sterile fluid.

Thirty-eight episodes occurred in children who had undergone hematopoietic stem cell transplantation (HSCT), and 179 in children who had not undergone HSCT. The presentation focused exclusively on the latter group.

Among episodes in children without HSCT, the mean age was 7. Forty-eight patients had a history of acute chest syndrome, 47 had a history of ICU admission, 29 had a history of IBI, and 27 had a history of acute splenic sequestration. Thirteen underwent a splenectomy. Almost half of children had none of these characteristics, while about one-fourth had two or more.

In the HSCT group, 141 children were on prophylaxis at the time of the infection; 74 were on hydroxyurea, and 36 were currently or previously on a transfusion program. Sixty-eight cases were primary bacteremia and 55 were osteoarticular. Other syndromes included pneumonia empyema (n = 18), and meningitis (n = 17), among others. In 44 cases, the isolated bacteria was Salmonella, followed by S. pneumoniae in 32 cases. Escherichia coli accounted for 22. Haemophilus influenza was identified in six episodes, and group A Streptococcus in three.

The study is the first large European epidemiologic study investigating IBI in children with sickle cell disease, and one of its strengths was the strict inclusion criteria. However, it was limited by its retrospective nature.

Dr. Gaschignard and Dr. Rohr have no relevant financial disclosures.

Infants with isolated sensorineural hearing loss as a result of congenital cytomegalovirus (cCMV) infection may benefit from treatment with valganciclovir, according to results from the CONCERT nonrandomized trial.

Subjects were found through the Newborn Hearing Screening program, using dried blood spot screening to confirm cCMV Infection. As a result of 6 weeks of therapy, more patients in the treatment group had improvements in hearing at age 20 months, and fewer had deterioration compared with untreated controls.

There is a general consensus that symptomatic cCMV should be treated with valganciclovir for 6 weeks or 6 months, but treatment of patients with only hearing loss is still under debate. The average age of participants was 8 weeks.

The study was presented by Pui Khi Chung, MD, a clinical microbiologist at the Leiden University Medical Center, the Netherlands, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Out of 1,377 NHS-referred infants, 59 were diagnosed with cCMV (4.3%), and 35 were included in the study. Twenty-five patients received 6 weeks of valganciclovir, while 10 patients received placebo. The control group was expanded to 12 when two additional subjects were identified retrospectively and were successfully followed up at 20 months. Subjects in the treatment group were an average of 8 weeks old when treatment began. Both groups had similar neurodevelopmental outcomes at 20 months, as measured by the Bayley Scales of Infant and Toddler Development (BSID-III) and the Child Development Inventory (CDI). There were no serious adverse events associated with treatment.

To measure efficacy, the researchers used a random intercept, random slope model that accounted for repeated measurements. The differences in slopes for analyses of the best ear were significantly different between the treatment and control groups (estimated difference in slopes, –0.93; P = .0071). Further analyses of total hearing found that improvement was more common in the treatment group, and deterioration/no change was more common in the nontreatment group (P = .044). In another analysis that excluded the most profoundly impaired ears (> 70 db hearing loss), none in the control group experienced improvement and almost half deteriorated. In the treatment group, most were unchanged and a small number improved, with almost none deteriorating (P = .006).

Asked whether the treatment has any effect on the most profoundly impaired ears, Dr. Chung said she had not yet completed that analysis, but the hypothesis is that the treatment is unlikely to lead to any improvement. “When you take out the severely impaired ears, you can see a greater [treatment] effect, so it does suggest that it doesn’t do anything for those ears,” Dr. Chung said during the Q&A session following her talk.

She was also asked why the treatment period was 6 weeks, rather than 6 months – a period of treatment that has shown a better effect on long-term hearing and developmental outcomes than 6 weeks of treatment in symptomatic patients. Dr. Chung replied that she wasn’t involved in the study design, but said that at her center, the 6-month regimen is not standard.

There were two key weaknesses in the study. One was the small sample size, and the other was its nonrandomized nature, which could have led to bias in the treated versus untreated group. “Although we don’t see any baseline differences between the groups, we have to be wary in analyses. Unfortunately, an RCT proved impossible in our setting. The CONCERT Trial started as randomized but this was amended to nonrandomized, as both parents and pediatricians had a clear preference for treatment,” said Dr. Chung.

The study could provide useful information about the timing of oral antiviral medication, according to Vana Spoulou, MD, who moderated the session where the research was presented. “The earliest you can give it is best, but sometimes it’s not easy to get them diagnosed immediately after birth. What they showed us is that even giving it so late, there was some improvement,” Dr. Spoulou said in an interview.

Dr. Spoulou isn’t ready to change practice based on the results, because she noted that some other studies have shown no benefit of treatment at 3 months. “But this was a hint that maybe even in these later diagnosed cases there could be some benefit,” she said.

Dr. Chung and Dr. Spoulou have no relevant financial disclosures.

Infants with isolated sensorineural hearing loss as a result of congenital cytomegalovirus (cCMV) infection may benefit from treatment with valganciclovir, according to results from the CONCERT nonrandomized trial.

Subjects were found through the Newborn Hearing Screening program, using dried blood spot screening to confirm cCMV Infection. As a result of 6 weeks of therapy, more patients in the treatment group had improvements in hearing at age 20 months, and fewer had deterioration compared with untreated controls.

There is a general consensus that symptomatic cCMV should be treated with valganciclovir for 6 weeks or 6 months, but treatment of patients with only hearing loss is still under debate. The average age of participants was 8 weeks.

The study was presented by Pui Khi Chung, MD, a clinical microbiologist at the Leiden University Medical Center, the Netherlands, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Out of 1,377 NHS-referred infants, 59 were diagnosed with cCMV (4.3%), and 35 were included in the study. Twenty-five patients received 6 weeks of valganciclovir, while 10 patients received placebo. The control group was expanded to 12 when two additional subjects were identified retrospectively and were successfully followed up at 20 months. Subjects in the treatment group were an average of 8 weeks old when treatment began. Both groups had similar neurodevelopmental outcomes at 20 months, as measured by the Bayley Scales of Infant and Toddler Development (BSID-III) and the Child Development Inventory (CDI). There were no serious adverse events associated with treatment.

To measure efficacy, the researchers used a random intercept, random slope model that accounted for repeated measurements. The differences in slopes for analyses of the best ear were significantly different between the treatment and control groups (estimated difference in slopes, –0.93; P = .0071). Further analyses of total hearing found that improvement was more common in the treatment group, and deterioration/no change was more common in the nontreatment group (P = .044). In another analysis that excluded the most profoundly impaired ears (> 70 db hearing loss), none in the control group experienced improvement and almost half deteriorated. In the treatment group, most were unchanged and a small number improved, with almost none deteriorating (P = .006).

Asked whether the treatment has any effect on the most profoundly impaired ears, Dr. Chung said she had not yet completed that analysis, but the hypothesis is that the treatment is unlikely to lead to any improvement. “When you take out the severely impaired ears, you can see a greater [treatment] effect, so it does suggest that it doesn’t do anything for those ears,” Dr. Chung said during the Q&A session following her talk.

She was also asked why the treatment period was 6 weeks, rather than 6 months – a period of treatment that has shown a better effect on long-term hearing and developmental outcomes than 6 weeks of treatment in symptomatic patients. Dr. Chung replied that she wasn’t involved in the study design, but said that at her center, the 6-month regimen is not standard.

There were two key weaknesses in the study. One was the small sample size, and the other was its nonrandomized nature, which could have led to bias in the treated versus untreated group. “Although we don’t see any baseline differences between the groups, we have to be wary in analyses. Unfortunately, an RCT proved impossible in our setting. The CONCERT Trial started as randomized but this was amended to nonrandomized, as both parents and pediatricians had a clear preference for treatment,” said Dr. Chung.

The study could provide useful information about the timing of oral antiviral medication, according to Vana Spoulou, MD, who moderated the session where the research was presented. “The earliest you can give it is best, but sometimes it’s not easy to get them diagnosed immediately after birth. What they showed us is that even giving it so late, there was some improvement,” Dr. Spoulou said in an interview.

Dr. Spoulou isn’t ready to change practice based on the results, because she noted that some other studies have shown no benefit of treatment at 3 months. “But this was a hint that maybe even in these later diagnosed cases there could be some benefit,” she said.

Dr. Chung and Dr. Spoulou have no relevant financial disclosures.

Infants with isolated sensorineural hearing loss as a result of congenital cytomegalovirus (cCMV) infection may benefit from treatment with valganciclovir, according to results from the CONCERT nonrandomized trial.

Subjects were found through the Newborn Hearing Screening program, using dried blood spot screening to confirm cCMV Infection. As a result of 6 weeks of therapy, more patients in the treatment group had improvements in hearing at age 20 months, and fewer had deterioration compared with untreated controls.

There is a general consensus that symptomatic cCMV should be treated with valganciclovir for 6 weeks or 6 months, but treatment of patients with only hearing loss is still under debate. The average age of participants was 8 weeks.

The study was presented by Pui Khi Chung, MD, a clinical microbiologist at the Leiden University Medical Center, the Netherlands, at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

Out of 1,377 NHS-referred infants, 59 were diagnosed with cCMV (4.3%), and 35 were included in the study. Twenty-five patients received 6 weeks of valganciclovir, while 10 patients received placebo. The control group was expanded to 12 when two additional subjects were identified retrospectively and were successfully followed up at 20 months. Subjects in the treatment group were an average of 8 weeks old when treatment began. Both groups had similar neurodevelopmental outcomes at 20 months, as measured by the Bayley Scales of Infant and Toddler Development (BSID-III) and the Child Development Inventory (CDI). There were no serious adverse events associated with treatment.

To measure efficacy, the researchers used a random intercept, random slope model that accounted for repeated measurements. The differences in slopes for analyses of the best ear were significantly different between the treatment and control groups (estimated difference in slopes, –0.93; P = .0071). Further analyses of total hearing found that improvement was more common in the treatment group, and deterioration/no change was more common in the nontreatment group (P = .044). In another analysis that excluded the most profoundly impaired ears (> 70 db hearing loss), none in the control group experienced improvement and almost half deteriorated. In the treatment group, most were unchanged and a small number improved, with almost none deteriorating (P = .006).

Asked whether the treatment has any effect on the most profoundly impaired ears, Dr. Chung said she had not yet completed that analysis, but the hypothesis is that the treatment is unlikely to lead to any improvement. “When you take out the severely impaired ears, you can see a greater [treatment] effect, so it does suggest that it doesn’t do anything for those ears,” Dr. Chung said during the Q&A session following her talk.

She was also asked why the treatment period was 6 weeks, rather than 6 months – a period of treatment that has shown a better effect on long-term hearing and developmental outcomes than 6 weeks of treatment in symptomatic patients. Dr. Chung replied that she wasn’t involved in the study design, but said that at her center, the 6-month regimen is not standard.

There were two key weaknesses in the study. One was the small sample size, and the other was its nonrandomized nature, which could have led to bias in the treated versus untreated group. “Although we don’t see any baseline differences between the groups, we have to be wary in analyses. Unfortunately, an RCT proved impossible in our setting. The CONCERT Trial started as randomized but this was amended to nonrandomized, as both parents and pediatricians had a clear preference for treatment,” said Dr. Chung.

The study could provide useful information about the timing of oral antiviral medication, according to Vana Spoulou, MD, who moderated the session where the research was presented. “The earliest you can give it is best, but sometimes it’s not easy to get them diagnosed immediately after birth. What they showed us is that even giving it so late, there was some improvement,” Dr. Spoulou said in an interview.

Dr. Spoulou isn’t ready to change practice based on the results, because she noted that some other studies have shown no benefit of treatment at 3 months. “But this was a hint that maybe even in these later diagnosed cases there could be some benefit,” she said.

Dr. Chung and Dr. Spoulou have no relevant financial disclosures.