Pediatrics

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

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

This article was been updated on 8/5/22 to include additional information about detransitioning.

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

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

This article was been updated on 8/5/22 to include additional information about detransitioning.

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

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

This article was been updated on 8/5/22 to include additional information about detransitioning.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

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

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

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

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

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

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

New COVID-19 cases rose for the second week in a row as cumulative cases among U.S. children passed the 14-million mark, but a recent survey shows that more than half of parents believe that the vaccine is a greater risk to children under age 5 years than the virus.

In a Kaiser Family Foundation survey conducted July 7-17, 53% of parents with children aged 6 months to 5 years said that the vaccine is “a bigger risk to their child’s health than getting infected with COVID-19, compared to 44% who say getting infected is the bigger risk,” KFF reported July 26.

More than 4 out of 10 of respondents (43%) said that they will “definitely not” get their eligible children vaccinated, while only 7% said that their children had already received it and 10% said their children would get it as soon as possible, according to the KFF survey, which had an overall sample size of 1,847 adults, including an oversample of 471 parents of children under age 5.

Vaccine initiation has been slow in the first month since it was approved for the youngest children. Just 2.8% of all eligible children under age 5 had received an initial dose as of July 19, compared with first-month uptake figures of more than 18% for the 5- to 11-year-olds and 27% for those aged 12-15, based on data from the Centers for Disease Control and Prevention.

The current rates for vaccination in those aged 5 and older look like this: 70.2% of 12- to 17-year-olds have received at least one dose, versus 37.1% of those aged 5-11. Just over 60% of the older children were fully vaccinated as of July 19, as were 30.2% of the 5- to 11-year-olds, the CDC reported on its COVID Data Tracker.
 

Number of new cases hits 2-month high

Despite the vaccine, SARS-CoV-2 and its various mutations have continued with their summer travels. With 92,000 newly infected children added for the week of July 15-21, there have now been a total of 14,003,497 pediatric cases reported since the start of the pandemic, which works out to 18.6% of cases in all ages, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

The 92,000 new cases represent an increase of almost 22% over the previous week and mark the highest 1-week count since May, when the total passed 100,000 for 2 consecutive weeks. More recently the trend had seemed more stable as weekly cases dropped twice and rose twice as the total hovered around 70,000, based on the data collected by the AAP and CHA from state and territorial health departments.

A different scenario has played out for emergency department visits and hospital admissions, which have risen steadily since the beginning of April. The admission rate for children aged 0-17, which was just 0.13 new patients per 100,000 population on April 11, was up to 0.44 per 100,000 on July 21. By comparison, the highest rate reached last year during the Delta surge was 0.47 per 100,000, based on CDC data.

The 7-day average of emergency dept. visits among the youngest age group, 0-11 years, shows the same general increase as hospital admissions, but the older children have diverged form that path (see graph). For those aged 12-15 and 16-17, hospitalizations started dropping in late May and into mid-June before climbing again, although more slowly than for the youngest group, the CDC data show.

The ED visit rate with diagnosed COVID among those aged 0-11, measured at 6.1% of all visits on July 19, is, in fact, considerably higher than at any time during the Delta surge last year, when it never passed 4.0%, although much lower than peak Omicron (14.1%). That 6.1% was also higher than any other age group on that day, adults included, the CDC said.

rfranki@mdedge.com

New COVID-19 cases rose for the second week in a row as cumulative cases among U.S. children passed the 14-million mark, but a recent survey shows that more than half of parents believe that the vaccine is a greater risk to children under age 5 years than the virus.

In a Kaiser Family Foundation survey conducted July 7-17, 53% of parents with children aged 6 months to 5 years said that the vaccine is “a bigger risk to their child’s health than getting infected with COVID-19, compared to 44% who say getting infected is the bigger risk,” KFF reported July 26.

More than 4 out of 10 of respondents (43%) said that they will “definitely not” get their eligible children vaccinated, while only 7% said that their children had already received it and 10% said their children would get it as soon as possible, according to the KFF survey, which had an overall sample size of 1,847 adults, including an oversample of 471 parents of children under age 5.

Vaccine initiation has been slow in the first month since it was approved for the youngest children. Just 2.8% of all eligible children under age 5 had received an initial dose as of July 19, compared with first-month uptake figures of more than 18% for the 5- to 11-year-olds and 27% for those aged 12-15, based on data from the Centers for Disease Control and Prevention.

The current rates for vaccination in those aged 5 and older look like this: 70.2% of 12- to 17-year-olds have received at least one dose, versus 37.1% of those aged 5-11. Just over 60% of the older children were fully vaccinated as of July 19, as were 30.2% of the 5- to 11-year-olds, the CDC reported on its COVID Data Tracker.
 

Number of new cases hits 2-month high

Despite the vaccine, SARS-CoV-2 and its various mutations have continued with their summer travels. With 92,000 newly infected children added for the week of July 15-21, there have now been a total of 14,003,497 pediatric cases reported since the start of the pandemic, which works out to 18.6% of cases in all ages, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

The 92,000 new cases represent an increase of almost 22% over the previous week and mark the highest 1-week count since May, when the total passed 100,000 for 2 consecutive weeks. More recently the trend had seemed more stable as weekly cases dropped twice and rose twice as the total hovered around 70,000, based on the data collected by the AAP and CHA from state and territorial health departments.

A different scenario has played out for emergency department visits and hospital admissions, which have risen steadily since the beginning of April. The admission rate for children aged 0-17, which was just 0.13 new patients per 100,000 population on April 11, was up to 0.44 per 100,000 on July 21. By comparison, the highest rate reached last year during the Delta surge was 0.47 per 100,000, based on CDC data.

The 7-day average of emergency dept. visits among the youngest age group, 0-11 years, shows the same general increase as hospital admissions, but the older children have diverged form that path (see graph). For those aged 12-15 and 16-17, hospitalizations started dropping in late May and into mid-June before climbing again, although more slowly than for the youngest group, the CDC data show.

The ED visit rate with diagnosed COVID among those aged 0-11, measured at 6.1% of all visits on July 19, is, in fact, considerably higher than at any time during the Delta surge last year, when it never passed 4.0%, although much lower than peak Omicron (14.1%). That 6.1% was also higher than any other age group on that day, adults included, the CDC said.

rfranki@mdedge.com

New COVID-19 cases rose for the second week in a row as cumulative cases among U.S. children passed the 14-million mark, but a recent survey shows that more than half of parents believe that the vaccine is a greater risk to children under age 5 years than the virus.

In a Kaiser Family Foundation survey conducted July 7-17, 53% of parents with children aged 6 months to 5 years said that the vaccine is “a bigger risk to their child’s health than getting infected with COVID-19, compared to 44% who say getting infected is the bigger risk,” KFF reported July 26.

More than 4 out of 10 of respondents (43%) said that they will “definitely not” get their eligible children vaccinated, while only 7% said that their children had already received it and 10% said their children would get it as soon as possible, according to the KFF survey, which had an overall sample size of 1,847 adults, including an oversample of 471 parents of children under age 5.

Vaccine initiation has been slow in the first month since it was approved for the youngest children. Just 2.8% of all eligible children under age 5 had received an initial dose as of July 19, compared with first-month uptake figures of more than 18% for the 5- to 11-year-olds and 27% for those aged 12-15, based on data from the Centers for Disease Control and Prevention.

The current rates for vaccination in those aged 5 and older look like this: 70.2% of 12- to 17-year-olds have received at least one dose, versus 37.1% of those aged 5-11. Just over 60% of the older children were fully vaccinated as of July 19, as were 30.2% of the 5- to 11-year-olds, the CDC reported on its COVID Data Tracker.
 

Number of new cases hits 2-month high

Despite the vaccine, SARS-CoV-2 and its various mutations have continued with their summer travels. With 92,000 newly infected children added for the week of July 15-21, there have now been a total of 14,003,497 pediatric cases reported since the start of the pandemic, which works out to 18.6% of cases in all ages, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

The 92,000 new cases represent an increase of almost 22% over the previous week and mark the highest 1-week count since May, when the total passed 100,000 for 2 consecutive weeks. More recently the trend had seemed more stable as weekly cases dropped twice and rose twice as the total hovered around 70,000, based on the data collected by the AAP and CHA from state and territorial health departments.

A different scenario has played out for emergency department visits and hospital admissions, which have risen steadily since the beginning of April. The admission rate for children aged 0-17, which was just 0.13 new patients per 100,000 population on April 11, was up to 0.44 per 100,000 on July 21. By comparison, the highest rate reached last year during the Delta surge was 0.47 per 100,000, based on CDC data.

The 7-day average of emergency dept. visits among the youngest age group, 0-11 years, shows the same general increase as hospital admissions, but the older children have diverged form that path (see graph). For those aged 12-15 and 16-17, hospitalizations started dropping in late May and into mid-June before climbing again, although more slowly than for the youngest group, the CDC data show.

The ED visit rate with diagnosed COVID among those aged 0-11, measured at 6.1% of all visits on July 19, is, in fact, considerably higher than at any time during the Delta surge last year, when it never passed 4.0%, although much lower than peak Omicron (14.1%). That 6.1% was also higher than any other age group on that day, adults included, the CDC said.

rfranki@mdedge.com

Emma Sherman, a 13-year-old girl in Ascot, England, woke up to a dizzying aura of blind spots and flashing lights in her field of vision. It was May 2020, and she also had crippling nausea and headaches. By August, her dizziness was so overwhelming, she couldn’t hold her head up, lying in her mother’s lap for hours, too fatigued to attend school.

The former competitive gymnast, who had hoped to try out for the cheerleading squad, now used a wheelchair and was a shadow of her former self. She had been diagnosed with COVID-induced postural orthostatic tachycardia syndrome, a condition often caused by an infection that results in a higher heart rate, extreme nausea, dizziness, and fatigue.

“I was so into sports before I got long COVID, and afterwards I could barely walk,” Emma said.

Even minor movements sent her heart rate sky-high. Her long chestnut hair turned gray and fell out in clumps. In the hospital, she was pricked and prodded, her blood tested for numerous conditions.

“They ran every scan known to man and took an MRI of her brain,” said Emma’s mother, Marie Sherman. “All was clear.”

Emma’s pediatrician determined that the teen had long COVID after having had a mild case of the virus in March, about 2 months before her puzzling symptoms began. But beyond a positive antibody test, doctors have found little evidence of what was causing Emma’s symptoms.

For Emma and others with long COVID, there are no medications shown to directly target the condition. Instead, caregivers target their symptoms, which include nausea, dizziness, fatigue, headaches, and a racing heart, said Laura Malone, MD, codirector of the Johns Hopkins Kennedy Krieger Pediatric Post–COVID-19 Rehabilitation Clinic in Baltimore.

“Right now, it’s a rehabilitation-based approach focused on improving symptoms and functioning so that kids can go back to their usual activities as much as possible,” she says.

Depression and anxiety are common, although doctors are struggling to figure out whether COVID is changing the brain or whether mental health symptoms result from all the life disruptions. There’s little research to show how may kids have depression because of long COVID. Dr. Malone said about half of her patients at the Kennedy Krieger Institute›s long COVID clinic are also dealing with mental health issues.

Patients with headaches, dizziness, and nausea are given pain and nausea medications and recommendations for a healthy diet with added fruits and vegetables, monounsaturated fats, lower sodium, unprocessed foods, and whole grains. Kids with irregular or racing heart rates are referred to cardiologists and potentially prescribed beta-blockers to treat their heart arrhythmias, while children with breathing problems may be referred to pulmonologists and those with depression to a psychiatrist.

Still, many patients like Emma go to their doctors with phantom symptoms that don’t show up on scans or blood tests.

“We’re not seeing any evidence of structural damage to the brain, for example,” said Dr. Malone. “When we do MRIs, they often come out normal.”

It’s possible that the virus lingers in some patients, said Rajeev Fernando, MD, an infectious disease specialist and a fellow at Harvard Medical School, Boston. Kids’ strong immune systems often fend off problems that can be noticed. But on the inside, dead fragments of the virus persist, floating in hidden parts of the body and activating the immune system long after the threat has passed.

The virus can be in the gut and in the brain, which may help explain why symptoms like brain fog and nausea can linger in children.

“The immune system doesn’t recognize whether fragments of the virus are dead or alive. It continues to think it’s fighting active COVID,” said Dr. Fernando.

There is little data on how long symptoms last, Dr. Fernando said, as well as how many kids get them and why some are more vulnerable than others. Some research has found that about 5%-15% of children with COVID may get long COVID, but the statistics vary globally.

“Children with long COVID have largely been ignored. And while we’re talking about it now, we’ve got some work to do,” said Dr. Fernando.

As for Emma, she recovered in January of 2021, heading back to school and her friends, although her cardiologist advised her to skip gym classes.

“For the first time in months, I was feeling like myself again,” she said.

But the coronavirus found its way to Emma again. Although she was fully vaccinated in the fall of 2021, when the Omicron variant swept the world late that year, she was infected again.

“When the wave of Omicron descended, Emma was like a sitting duck,” her mother said.

She was bedridden with a high fever and cough. The cold-like symptoms eventually went away, but the issues in her gut stuck around. Since then, Emma has had extreme nausea, losing most of the weight she had gained back.

For her part, Ms. Sherman has found solace in a group called Long COVID Kids, a nonprofit in Europe and the United States. The group is raising awareness about the condition in kids to increase funding, boost understanding, and improve treatment and outcomes.

“There’s nothing worse than watching your child suffer and not being able to do anything about it,” she said. “I tell Emma all the time: If I could just crawl in your body and take it, I would do it in a second.”

Emma is hoping for a fresh start with her family’s move in the coming weeks to Sotogrande in southern Spain.

“I miss the simplest things like going for a run, going to the fair with my friends, and just feeling well,” she said. “I have a long list of things I’ll do once this is all done.”

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

Emma Sherman, a 13-year-old girl in Ascot, England, woke up to a dizzying aura of blind spots and flashing lights in her field of vision. It was May 2020, and she also had crippling nausea and headaches. By August, her dizziness was so overwhelming, she couldn’t hold her head up, lying in her mother’s lap for hours, too fatigued to attend school.

The former competitive gymnast, who had hoped to try out for the cheerleading squad, now used a wheelchair and was a shadow of her former self. She had been diagnosed with COVID-induced postural orthostatic tachycardia syndrome, a condition often caused by an infection that results in a higher heart rate, extreme nausea, dizziness, and fatigue.

“I was so into sports before I got long COVID, and afterwards I could barely walk,” Emma said.

Even minor movements sent her heart rate sky-high. Her long chestnut hair turned gray and fell out in clumps. In the hospital, she was pricked and prodded, her blood tested for numerous conditions.

“They ran every scan known to man and took an MRI of her brain,” said Emma’s mother, Marie Sherman. “All was clear.”

Emma’s pediatrician determined that the teen had long COVID after having had a mild case of the virus in March, about 2 months before her puzzling symptoms began. But beyond a positive antibody test, doctors have found little evidence of what was causing Emma’s symptoms.

For Emma and others with long COVID, there are no medications shown to directly target the condition. Instead, caregivers target their symptoms, which include nausea, dizziness, fatigue, headaches, and a racing heart, said Laura Malone, MD, codirector of the Johns Hopkins Kennedy Krieger Pediatric Post–COVID-19 Rehabilitation Clinic in Baltimore.

“Right now, it’s a rehabilitation-based approach focused on improving symptoms and functioning so that kids can go back to their usual activities as much as possible,” she says.

Depression and anxiety are common, although doctors are struggling to figure out whether COVID is changing the brain or whether mental health symptoms result from all the life disruptions. There’s little research to show how may kids have depression because of long COVID. Dr. Malone said about half of her patients at the Kennedy Krieger Institute›s long COVID clinic are also dealing with mental health issues.

Patients with headaches, dizziness, and nausea are given pain and nausea medications and recommendations for a healthy diet with added fruits and vegetables, monounsaturated fats, lower sodium, unprocessed foods, and whole grains. Kids with irregular or racing heart rates are referred to cardiologists and potentially prescribed beta-blockers to treat their heart arrhythmias, while children with breathing problems may be referred to pulmonologists and those with depression to a psychiatrist.

Still, many patients like Emma go to their doctors with phantom symptoms that don’t show up on scans or blood tests.

“We’re not seeing any evidence of structural damage to the brain, for example,” said Dr. Malone. “When we do MRIs, they often come out normal.”

It’s possible that the virus lingers in some patients, said Rajeev Fernando, MD, an infectious disease specialist and a fellow at Harvard Medical School, Boston. Kids’ strong immune systems often fend off problems that can be noticed. But on the inside, dead fragments of the virus persist, floating in hidden parts of the body and activating the immune system long after the threat has passed.

The virus can be in the gut and in the brain, which may help explain why symptoms like brain fog and nausea can linger in children.

“The immune system doesn’t recognize whether fragments of the virus are dead or alive. It continues to think it’s fighting active COVID,” said Dr. Fernando.

There is little data on how long symptoms last, Dr. Fernando said, as well as how many kids get them and why some are more vulnerable than others. Some research has found that about 5%-15% of children with COVID may get long COVID, but the statistics vary globally.

“Children with long COVID have largely been ignored. And while we’re talking about it now, we’ve got some work to do,” said Dr. Fernando.

As for Emma, she recovered in January of 2021, heading back to school and her friends, although her cardiologist advised her to skip gym classes.

“For the first time in months, I was feeling like myself again,” she said.

But the coronavirus found its way to Emma again. Although she was fully vaccinated in the fall of 2021, when the Omicron variant swept the world late that year, she was infected again.

“When the wave of Omicron descended, Emma was like a sitting duck,” her mother said.

She was bedridden with a high fever and cough. The cold-like symptoms eventually went away, but the issues in her gut stuck around. Since then, Emma has had extreme nausea, losing most of the weight she had gained back.

For her part, Ms. Sherman has found solace in a group called Long COVID Kids, a nonprofit in Europe and the United States. The group is raising awareness about the condition in kids to increase funding, boost understanding, and improve treatment and outcomes.

“There’s nothing worse than watching your child suffer and not being able to do anything about it,” she said. “I tell Emma all the time: If I could just crawl in your body and take it, I would do it in a second.”

Emma is hoping for a fresh start with her family’s move in the coming weeks to Sotogrande in southern Spain.

“I miss the simplest things like going for a run, going to the fair with my friends, and just feeling well,” she said. “I have a long list of things I’ll do once this is all done.”

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

Emma Sherman, a 13-year-old girl in Ascot, England, woke up to a dizzying aura of blind spots and flashing lights in her field of vision. It was May 2020, and she also had crippling nausea and headaches. By August, her dizziness was so overwhelming, she couldn’t hold her head up, lying in her mother’s lap for hours, too fatigued to attend school.

The former competitive gymnast, who had hoped to try out for the cheerleading squad, now used a wheelchair and was a shadow of her former self. She had been diagnosed with COVID-induced postural orthostatic tachycardia syndrome, a condition often caused by an infection that results in a higher heart rate, extreme nausea, dizziness, and fatigue.

“I was so into sports before I got long COVID, and afterwards I could barely walk,” Emma said.

Even minor movements sent her heart rate sky-high. Her long chestnut hair turned gray and fell out in clumps. In the hospital, she was pricked and prodded, her blood tested for numerous conditions.

“They ran every scan known to man and took an MRI of her brain,” said Emma’s mother, Marie Sherman. “All was clear.”

Emma’s pediatrician determined that the teen had long COVID after having had a mild case of the virus in March, about 2 months before her puzzling symptoms began. But beyond a positive antibody test, doctors have found little evidence of what was causing Emma’s symptoms.

For Emma and others with long COVID, there are no medications shown to directly target the condition. Instead, caregivers target their symptoms, which include nausea, dizziness, fatigue, headaches, and a racing heart, said Laura Malone, MD, codirector of the Johns Hopkins Kennedy Krieger Pediatric Post–COVID-19 Rehabilitation Clinic in Baltimore.

“Right now, it’s a rehabilitation-based approach focused on improving symptoms and functioning so that kids can go back to their usual activities as much as possible,” she says.

Depression and anxiety are common, although doctors are struggling to figure out whether COVID is changing the brain or whether mental health symptoms result from all the life disruptions. There’s little research to show how may kids have depression because of long COVID. Dr. Malone said about half of her patients at the Kennedy Krieger Institute›s long COVID clinic are also dealing with mental health issues.

Patients with headaches, dizziness, and nausea are given pain and nausea medications and recommendations for a healthy diet with added fruits and vegetables, monounsaturated fats, lower sodium, unprocessed foods, and whole grains. Kids with irregular or racing heart rates are referred to cardiologists and potentially prescribed beta-blockers to treat their heart arrhythmias, while children with breathing problems may be referred to pulmonologists and those with depression to a psychiatrist.

Still, many patients like Emma go to their doctors with phantom symptoms that don’t show up on scans or blood tests.

“We’re not seeing any evidence of structural damage to the brain, for example,” said Dr. Malone. “When we do MRIs, they often come out normal.”

It’s possible that the virus lingers in some patients, said Rajeev Fernando, MD, an infectious disease specialist and a fellow at Harvard Medical School, Boston. Kids’ strong immune systems often fend off problems that can be noticed. But on the inside, dead fragments of the virus persist, floating in hidden parts of the body and activating the immune system long after the threat has passed.

The virus can be in the gut and in the brain, which may help explain why symptoms like brain fog and nausea can linger in children.

“The immune system doesn’t recognize whether fragments of the virus are dead or alive. It continues to think it’s fighting active COVID,” said Dr. Fernando.

There is little data on how long symptoms last, Dr. Fernando said, as well as how many kids get them and why some are more vulnerable than others. Some research has found that about 5%-15% of children with COVID may get long COVID, but the statistics vary globally.

“Children with long COVID have largely been ignored. And while we’re talking about it now, we’ve got some work to do,” said Dr. Fernando.

As for Emma, she recovered in January of 2021, heading back to school and her friends, although her cardiologist advised her to skip gym classes.

“For the first time in months, I was feeling like myself again,” she said.

But the coronavirus found its way to Emma again. Although she was fully vaccinated in the fall of 2021, when the Omicron variant swept the world late that year, she was infected again.

“When the wave of Omicron descended, Emma was like a sitting duck,” her mother said.

She was bedridden with a high fever and cough. The cold-like symptoms eventually went away, but the issues in her gut stuck around. Since then, Emma has had extreme nausea, losing most of the weight she had gained back.

For her part, Ms. Sherman has found solace in a group called Long COVID Kids, a nonprofit in Europe and the United States. The group is raising awareness about the condition in kids to increase funding, boost understanding, and improve treatment and outcomes.

“There’s nothing worse than watching your child suffer and not being able to do anything about it,” she said. “I tell Emma all the time: If I could just crawl in your body and take it, I would do it in a second.”

Emma is hoping for a fresh start with her family’s move in the coming weeks to Sotogrande in southern Spain.

“I miss the simplest things like going for a run, going to the fair with my friends, and just feeling well,” she said. “I have a long list of things I’ll do once this is all done.”

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

INDIANAPOLIS – An investigational topical treatment for dystrophic epidermolysis bullosa (DEB) known as beremagene geperpavec (B-VEC) showed durable and statistically significant improvement in complete wound healing at 3 and 6 months compared with placebo, according to results from a small phase 3 study.

DEB is a serious, ultra-rare genetic blistering disease caused by mutations in the COL7A1 gene, encoding for type VII collagen and leading to skin fragility and wounds. No approved therapies are currently available. In the study, treatment was generally well tolerated.

Doug Brunk/MDedge News

“B-VEC is the first treatment that has not only been shown to be effective, but the first to directly target the defect through topical application,” the study’s principal investigator, Shireen V. Guide, MD, said in an interview during a poster session at the annual meeting of the Society for Pediatric Dermatology. “It delivers type VII collagen gene therapy to these patients, which allows healing in areas that they may have had open since birth. It’s been life-changing for them.”

B-VEC is a herpes simplex virus (HSV-1)-based topical, redosable gene therapy being developed by Krystal Biotech that is designed to restore functional COL7 protein by delivering the COL7A1 gene. For the phase 3, multicenter, double-blind, placebo-controlled study known GEM-3, Dr. Guide, who practices dermatology in Rancho Santa Margarita, Calif., and her colleagues, including Peter Marinkovich, MD, from Stanford (Calif.) University, and Mercedes Gonzalez, MD, from the University of Miami, enrolled 31 patients aged 6 months and older with genetically confirmed DEB. Each patient had one wound treated randomized 1:1 to treatment with B-VEC once a week or placebo for 6 months. The mean age of the 31 study participants was 17 years, 65% were male, 65% were White, and 19% were Asian.

The primary endpoint was complete wound healing (defined as 100% wound closure from exact wound area at baseline, specified as skin re-epithelialization without drainage) at 6 months. Additional endpoints included complete wound healing at 3 months and change in pain associated with wound dressing changes.

At 3 months, 70% of wounds treated with B-VEC met the endpoint of complete wound healing, compared with 20% of wounds treated with placebo (P < .005). At 6 months, 67% of wounds treated with B-VEC met the endpoint of complete wound healing compared with 22% of those treated with placebo (P < .005).

Of the total wounds that closed at 3 months, 67% of wounds treated with B-VEC were also closed at 6 months, compared with 33% of those treated with placebo (P = .02). In other findings, a trend toward decreased pain was observed in wounds treated with B-VEC vs. those treated with placebo.

B-VEC was well tolerated with no treatment-related serious adverse events or discontinuations. Three patients experienced a total of five serious adverse events during the study: anemia (two events), and cellulitis, diarrhea, and positive blood culture (one event each). None were considered related to the study drug.

Dr. Guide, who is on staff at Children’s Health of Orange County, Orange, Calif., characterized B-VEC as “very novel because it’s very practical.”

To date, all treatments for DEB “have been extremely labor intensive, including skin grafting and hospitalizations. It’s a topical application that can be done in the office and potentially applied at home in the future. It’s also durable. Not only are the [treated] areas closing, but they are staying closed.”

Kalyani S. Marathe, MD, MPH, director of the dermatology division at Cincinnati Children’s Hospital, who was asked to comment on the study, said that topical application of B-VEC “allows the side effect profile to be very favorable. The results are remarkable in the amount of wound healing and reduction in pain.”

The tolerability of this medication “is crucial,” she added. “EB patients have a lot of pain from their wounds and so any treatment needs to be as painless as possible for it to be usable. I’m very excited about the next phase of studies for this medication and hopeful that it heralds new treatments for our EB patients.”

In June 2022, the manufacturer announced that it had submitted a biologics license application to the Food and Drug Administration for approval of B-VEC for the treatment of DEB, and that it anticipates submitting an application for marketing authorization with the European Medical Agency (EMA) in the second half of 2022.

Dr. Guide disclosed that she has served as an investigator for Krystal Biotech, Innovaderm Research, Arcutis, Premier Research, Paidion, and Castle Biosciences. Dr. Marathe disclosed that she has served as an adviser for Verrica, and that Cincinnati Children’s Hospital is a site for the next phase studies for B-VEC.

*This story was updated on July 25. 

INDIANAPOLIS – An investigational topical treatment for dystrophic epidermolysis bullosa (DEB) known as beremagene geperpavec (B-VEC) showed durable and statistically significant improvement in complete wound healing at 3 and 6 months compared with placebo, according to results from a small phase 3 study.

DEB is a serious, ultra-rare genetic blistering disease caused by mutations in the COL7A1 gene, encoding for type VII collagen and leading to skin fragility and wounds. No approved therapies are currently available. In the study, treatment was generally well tolerated.

Doug Brunk/MDedge News

“B-VEC is the first treatment that has not only been shown to be effective, but the first to directly target the defect through topical application,” the study’s principal investigator, Shireen V. Guide, MD, said in an interview during a poster session at the annual meeting of the Society for Pediatric Dermatology. “It delivers type VII collagen gene therapy to these patients, which allows healing in areas that they may have had open since birth. It’s been life-changing for them.”

B-VEC is a herpes simplex virus (HSV-1)-based topical, redosable gene therapy being developed by Krystal Biotech that is designed to restore functional COL7 protein by delivering the COL7A1 gene. For the phase 3, multicenter, double-blind, placebo-controlled study known GEM-3, Dr. Guide, who practices dermatology in Rancho Santa Margarita, Calif., and her colleagues, including Peter Marinkovich, MD, from Stanford (Calif.) University, and Mercedes Gonzalez, MD, from the University of Miami, enrolled 31 patients aged 6 months and older with genetically confirmed DEB. Each patient had one wound treated randomized 1:1 to treatment with B-VEC once a week or placebo for 6 months. The mean age of the 31 study participants was 17 years, 65% were male, 65% were White, and 19% were Asian.

The primary endpoint was complete wound healing (defined as 100% wound closure from exact wound area at baseline, specified as skin re-epithelialization without drainage) at 6 months. Additional endpoints included complete wound healing at 3 months and change in pain associated with wound dressing changes.

At 3 months, 70% of wounds treated with B-VEC met the endpoint of complete wound healing, compared with 20% of wounds treated with placebo (P < .005). At 6 months, 67% of wounds treated with B-VEC met the endpoint of complete wound healing compared with 22% of those treated with placebo (P < .005).

Of the total wounds that closed at 3 months, 67% of wounds treated with B-VEC were also closed at 6 months, compared with 33% of those treated with placebo (P = .02). In other findings, a trend toward decreased pain was observed in wounds treated with B-VEC vs. those treated with placebo.

B-VEC was well tolerated with no treatment-related serious adverse events or discontinuations. Three patients experienced a total of five serious adverse events during the study: anemia (two events), and cellulitis, diarrhea, and positive blood culture (one event each). None were considered related to the study drug.

Dr. Guide, who is on staff at Children’s Health of Orange County, Orange, Calif., characterized B-VEC as “very novel because it’s very practical.”

To date, all treatments for DEB “have been extremely labor intensive, including skin grafting and hospitalizations. It’s a topical application that can be done in the office and potentially applied at home in the future. It’s also durable. Not only are the [treated] areas closing, but they are staying closed.”

Kalyani S. Marathe, MD, MPH, director of the dermatology division at Cincinnati Children’s Hospital, who was asked to comment on the study, said that topical application of B-VEC “allows the side effect profile to be very favorable. The results are remarkable in the amount of wound healing and reduction in pain.”

The tolerability of this medication “is crucial,” she added. “EB patients have a lot of pain from their wounds and so any treatment needs to be as painless as possible for it to be usable. I’m very excited about the next phase of studies for this medication and hopeful that it heralds new treatments for our EB patients.”

In June 2022, the manufacturer announced that it had submitted a biologics license application to the Food and Drug Administration for approval of B-VEC for the treatment of DEB, and that it anticipates submitting an application for marketing authorization with the European Medical Agency (EMA) in the second half of 2022.

Dr. Guide disclosed that she has served as an investigator for Krystal Biotech, Innovaderm Research, Arcutis, Premier Research, Paidion, and Castle Biosciences. Dr. Marathe disclosed that she has served as an adviser for Verrica, and that Cincinnati Children’s Hospital is a site for the next phase studies for B-VEC.

*This story was updated on July 25. 

INDIANAPOLIS – An investigational topical treatment for dystrophic epidermolysis bullosa (DEB) known as beremagene geperpavec (B-VEC) showed durable and statistically significant improvement in complete wound healing at 3 and 6 months compared with placebo, according to results from a small phase 3 study.

DEB is a serious, ultra-rare genetic blistering disease caused by mutations in the COL7A1 gene, encoding for type VII collagen and leading to skin fragility and wounds. No approved therapies are currently available. In the study, treatment was generally well tolerated.

Doug Brunk/MDedge News

“B-VEC is the first treatment that has not only been shown to be effective, but the first to directly target the defect through topical application,” the study’s principal investigator, Shireen V. Guide, MD, said in an interview during a poster session at the annual meeting of the Society for Pediatric Dermatology. “It delivers type VII collagen gene therapy to these patients, which allows healing in areas that they may have had open since birth. It’s been life-changing for them.”

B-VEC is a herpes simplex virus (HSV-1)-based topical, redosable gene therapy being developed by Krystal Biotech that is designed to restore functional COL7 protein by delivering the COL7A1 gene. For the phase 3, multicenter, double-blind, placebo-controlled study known GEM-3, Dr. Guide, who practices dermatology in Rancho Santa Margarita, Calif., and her colleagues, including Peter Marinkovich, MD, from Stanford (Calif.) University, and Mercedes Gonzalez, MD, from the University of Miami, enrolled 31 patients aged 6 months and older with genetically confirmed DEB. Each patient had one wound treated randomized 1:1 to treatment with B-VEC once a week or placebo for 6 months. The mean age of the 31 study participants was 17 years, 65% were male, 65% were White, and 19% were Asian.

The primary endpoint was complete wound healing (defined as 100% wound closure from exact wound area at baseline, specified as skin re-epithelialization without drainage) at 6 months. Additional endpoints included complete wound healing at 3 months and change in pain associated with wound dressing changes.

At 3 months, 70% of wounds treated with B-VEC met the endpoint of complete wound healing, compared with 20% of wounds treated with placebo (P < .005). At 6 months, 67% of wounds treated with B-VEC met the endpoint of complete wound healing compared with 22% of those treated with placebo (P < .005).

Of the total wounds that closed at 3 months, 67% of wounds treated with B-VEC were also closed at 6 months, compared with 33% of those treated with placebo (P = .02). In other findings, a trend toward decreased pain was observed in wounds treated with B-VEC vs. those treated with placebo.

B-VEC was well tolerated with no treatment-related serious adverse events or discontinuations. Three patients experienced a total of five serious adverse events during the study: anemia (two events), and cellulitis, diarrhea, and positive blood culture (one event each). None were considered related to the study drug.

Dr. Guide, who is on staff at Children’s Health of Orange County, Orange, Calif., characterized B-VEC as “very novel because it’s very practical.”

To date, all treatments for DEB “have been extremely labor intensive, including skin grafting and hospitalizations. It’s a topical application that can be done in the office and potentially applied at home in the future. It’s also durable. Not only are the [treated] areas closing, but they are staying closed.”

Kalyani S. Marathe, MD, MPH, director of the dermatology division at Cincinnati Children’s Hospital, who was asked to comment on the study, said that topical application of B-VEC “allows the side effect profile to be very favorable. The results are remarkable in the amount of wound healing and reduction in pain.”

The tolerability of this medication “is crucial,” she added. “EB patients have a lot of pain from their wounds and so any treatment needs to be as painless as possible for it to be usable. I’m very excited about the next phase of studies for this medication and hopeful that it heralds new treatments for our EB patients.”

In June 2022, the manufacturer announced that it had submitted a biologics license application to the Food and Drug Administration for approval of B-VEC for the treatment of DEB, and that it anticipates submitting an application for marketing authorization with the European Medical Agency (EMA) in the second half of 2022.

Dr. Guide disclosed that she has served as an investigator for Krystal Biotech, Innovaderm Research, Arcutis, Premier Research, Paidion, and Castle Biosciences. Dr. Marathe disclosed that she has served as an adviser for Verrica, and that Cincinnati Children’s Hospital is a site for the next phase studies for B-VEC.

*This story was updated on July 25. 

How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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

How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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

How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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