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Children and COVID: Youngest vaccinees off to a slower start
Specific figures for children aged 5-11 years are not yet available, but CDC data show that 1.55 million children under the age of 12 years had received at least one dose of COVID-19 vaccine as of Nov. 15, of whom almost 204,000 already had been vaccinated before Nov. 2. For children aged 12-15, the first 2 weeks after approval on May 12 produced almost 2.1 million vaccine initiations, according to the CDC’s COVID Data Tracker.
That dataset reveals several other noteworthy differences between the two age groups in the 10 days after approval:
- There were over 7,000 vaccine initiations on the first day in the 12-15 group; the younger group had 32.
- The older children reached 100,000 per day in 3 days; the younger children took 8 days.
- The older group topped 200,000 vaccinations per day on six different days; the younger group didn’t get above 175,000.
Children under 12 made up 27.5% of vaccine initiations in all age groups during the 2 weeks from Nov. 2 to Nov. 15, versus 3.4% for 12- to 15-year-olds and 1.2% for 16- and 17-year-olds, the CDC said, while also reporting that 3.6% of children under age 12 had received at least one dose of the COVID vaccine, compared with 57.8% of those aged 12-15 and 64.4% of 16- to 17-year-olds.
Meanwhile, the first full week of November marked the second consecutive increase in the number of weekly child COVID cases, with 122,000 reported for Nov. 5-11. The number of new cases has now surpassed 100,000 for 14 consecutive weeks, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID report. That report, which covers state health departments, has not included current information from Alabama, Nebraska, and Texas since the summer.
Regionally, the increases over the past 2 weeks were spread out among the East, the Midwest, and the West, while the decline that had been going on for several weeks in the South has largely come to a halt. The states with the highest percent increases over those 2 weeks are all in New England: Maine, New Hampshire, and Vermont, the AAP and CHA noted. In a separate report, the AAP said that Vermont has the second-highest child vaccination rate (81%) in the country, just behind Massachusetts (82%).
Specific figures for children aged 5-11 years are not yet available, but CDC data show that 1.55 million children under the age of 12 years had received at least one dose of COVID-19 vaccine as of Nov. 15, of whom almost 204,000 already had been vaccinated before Nov. 2. For children aged 12-15, the first 2 weeks after approval on May 12 produced almost 2.1 million vaccine initiations, according to the CDC’s COVID Data Tracker.
That dataset reveals several other noteworthy differences between the two age groups in the 10 days after approval:
- There were over 7,000 vaccine initiations on the first day in the 12-15 group; the younger group had 32.
- The older children reached 100,000 per day in 3 days; the younger children took 8 days.
- The older group topped 200,000 vaccinations per day on six different days; the younger group didn’t get above 175,000.
Children under 12 made up 27.5% of vaccine initiations in all age groups during the 2 weeks from Nov. 2 to Nov. 15, versus 3.4% for 12- to 15-year-olds and 1.2% for 16- and 17-year-olds, the CDC said, while also reporting that 3.6% of children under age 12 had received at least one dose of the COVID vaccine, compared with 57.8% of those aged 12-15 and 64.4% of 16- to 17-year-olds.
Meanwhile, the first full week of November marked the second consecutive increase in the number of weekly child COVID cases, with 122,000 reported for Nov. 5-11. The number of new cases has now surpassed 100,000 for 14 consecutive weeks, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID report. That report, which covers state health departments, has not included current information from Alabama, Nebraska, and Texas since the summer.
Regionally, the increases over the past 2 weeks were spread out among the East, the Midwest, and the West, while the decline that had been going on for several weeks in the South has largely come to a halt. The states with the highest percent increases over those 2 weeks are all in New England: Maine, New Hampshire, and Vermont, the AAP and CHA noted. In a separate report, the AAP said that Vermont has the second-highest child vaccination rate (81%) in the country, just behind Massachusetts (82%).
Specific figures for children aged 5-11 years are not yet available, but CDC data show that 1.55 million children under the age of 12 years had received at least one dose of COVID-19 vaccine as of Nov. 15, of whom almost 204,000 already had been vaccinated before Nov. 2. For children aged 12-15, the first 2 weeks after approval on May 12 produced almost 2.1 million vaccine initiations, according to the CDC’s COVID Data Tracker.
That dataset reveals several other noteworthy differences between the two age groups in the 10 days after approval:
- There were over 7,000 vaccine initiations on the first day in the 12-15 group; the younger group had 32.
- The older children reached 100,000 per day in 3 days; the younger children took 8 days.
- The older group topped 200,000 vaccinations per day on six different days; the younger group didn’t get above 175,000.
Children under 12 made up 27.5% of vaccine initiations in all age groups during the 2 weeks from Nov. 2 to Nov. 15, versus 3.4% for 12- to 15-year-olds and 1.2% for 16- and 17-year-olds, the CDC said, while also reporting that 3.6% of children under age 12 had received at least one dose of the COVID vaccine, compared with 57.8% of those aged 12-15 and 64.4% of 16- to 17-year-olds.
Meanwhile, the first full week of November marked the second consecutive increase in the number of weekly child COVID cases, with 122,000 reported for Nov. 5-11. The number of new cases has now surpassed 100,000 for 14 consecutive weeks, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID report. That report, which covers state health departments, has not included current information from Alabama, Nebraska, and Texas since the summer.
Regionally, the increases over the past 2 weeks were spread out among the East, the Midwest, and the West, while the decline that had been going on for several weeks in the South has largely come to a halt. The states with the highest percent increases over those 2 weeks are all in New England: Maine, New Hampshire, and Vermont, the AAP and CHA noted. In a separate report, the AAP said that Vermont has the second-highest child vaccination rate (81%) in the country, just behind Massachusetts (82%).
Two-thirds of preschoolers correctly identified emotions of masked adults
Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.
In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.
Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X2 and Cramer V tests.
Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).
No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.
“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.
The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.
Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.
The study received no outside funding. The researchers had no relevant financial conflicts to disclose.
Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.
In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.
Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X2 and Cramer V tests.
Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).
No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.
“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.
The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.
Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.
The study received no outside funding. The researchers had no relevant financial conflicts to disclose.
Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.
In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.
Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X2 and Cramer V tests.
Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).
No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.
“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.
The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.
Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.
The study received no outside funding. The researchers had no relevant financial conflicts to disclose.
FROM JAMA PEDIATRICS
What is the diagnosis?
Numerous morphologies of skin rashes have been described in the setting of COVID-19, including pernio, livedoid rash, exanthem, and vasculitis. This classic constellation of symptoms (palpable purpura on buttocks/legs, abdominal pain, arthralgia, hematuria) is highly consistent with Henoch-Schonlein purpura (HSP). There are now multiple case reports of COVID-19–associated HSP.
HSP is the most common type of childhood systemic vasculitis. It is mediated by immunoglobulin A (IgA) immune complex deposition and has been associated with respiratory tract infections, streptococcal species, parainfluenza virus, and human parvovirus B19, medications, vaccinations, and malignancies. HSP is usually a self-limiting disease, with a course over 4-6 weeks, and can affect multiple organs, including the skin, gastrointestinal tract, joints, and the kidneys. The diagnostic criteria include palpable purpura in the presence of one or more of the following: diffuse abdominal pain, arthritis or arthralgia, any biopsy showing predominant IgA deposition, and renal involvement in the form of hematuria or proteinuria. Renal disease is variable and is the most significant indicator of long-term prognosis. This teenager was treated with oral corticosteroids because of the severe periarticular edema and responded rapidly. His subsequent urine analyses normalized.
What is on the differential?
Multisystem inflammatory syndrome in children (MIS-C) is a rare, potentially fatal, complication of COVID-19 infection that causes inflammation of multiple organs, including the heart, lungs, kidneys, brain, skin, eyes, or the gastrointestinal tract. It commonly affects children around ages 8-9 years. Initial symptoms include fever, rash, red eyes, diarrhea, and vomiting that appear 2-6 weeks post COVID-19 infection. Like HSP, MIS-C can present with edema of the extremities, worsening hand/foot pain, and hematuria; however, the absence of both fever and the pattern of system involvement seen with MIS-C and classic findings in this patient are more consistent with HSP.
Reactive infectious mucocutaneous eruption (RIME) was recently coined to encompass both infection-associated Stevens-Johnson eruptions including Mycoplasma pneumoniae-induced rash and mucositis (MIRM) and mucocutaneous eruptions caused by nonmycoplasma pathogens (including Chlamydia pneumoniae, human parainfluenza virus 2, rhinovirus, adenovirus, enterovirus, human metapneumovirus, influenza B virus, and COVID-19). It is usually seen in male children and adolescents. Prodromal symptoms include cough, fever, and malaise and they precede the prominent feature of mucositis. Our patient’s lack of mucosal involvement is not consistent with RIME.
Perniosis (chilblains) is characterized by localized edematous patches of erythema or cyanosis on exposed extremities, that may be associated with cold exposure. Lesions are usually symmetric and self-limiting, and symptoms can include numbness, tingling, pruritus, burning, or pain. Pernio-like skin lesions have been seen during the COVID-19 pandemic, though many patients have negative testing for infection by PCR and serology. Pernio may also be seen with autoimmune diseases or malignancy.
Meningococcemia is a rare disease caused by infection with gram-negative diplococci bacteria Neisseria meningitidis and spreads through saliva or respiratory secretions. Its clinical presentation can vary widely, from transient fever to fulminant disease. It is characterized by upper respiratory tract infection, fever, and petechial lesions associated with thrombocytopenia and coagulopathy.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Laborada is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Laborada have no relevant financial disclosures.
References
AlGhoozi DA, AlKhayyat HM. BMJ Case Reports CP 2021;14:e239910.
Jacobi M et al. Pediatr Infect Dis J. 2021;40(2):e93-4.
Paller A, Mancini AJ. Hurwitz clinical pediatric dermatology: A textbook of skin disorders of childhood and adolescence. 4th ed. Philadelphia (PA): Elsevier Saunders; 2011.
Radia T et al. Paediatr Respir Rev. 2021;38:51-7.
Ramien ML. Clin Exp Dermatol. 2021;46(3):420-9.
Numerous morphologies of skin rashes have been described in the setting of COVID-19, including pernio, livedoid rash, exanthem, and vasculitis. This classic constellation of symptoms (palpable purpura on buttocks/legs, abdominal pain, arthralgia, hematuria) is highly consistent with Henoch-Schonlein purpura (HSP). There are now multiple case reports of COVID-19–associated HSP.
HSP is the most common type of childhood systemic vasculitis. It is mediated by immunoglobulin A (IgA) immune complex deposition and has been associated with respiratory tract infections, streptococcal species, parainfluenza virus, and human parvovirus B19, medications, vaccinations, and malignancies. HSP is usually a self-limiting disease, with a course over 4-6 weeks, and can affect multiple organs, including the skin, gastrointestinal tract, joints, and the kidneys. The diagnostic criteria include palpable purpura in the presence of one or more of the following: diffuse abdominal pain, arthritis or arthralgia, any biopsy showing predominant IgA deposition, and renal involvement in the form of hematuria or proteinuria. Renal disease is variable and is the most significant indicator of long-term prognosis. This teenager was treated with oral corticosteroids because of the severe periarticular edema and responded rapidly. His subsequent urine analyses normalized.
What is on the differential?
Multisystem inflammatory syndrome in children (MIS-C) is a rare, potentially fatal, complication of COVID-19 infection that causes inflammation of multiple organs, including the heart, lungs, kidneys, brain, skin, eyes, or the gastrointestinal tract. It commonly affects children around ages 8-9 years. Initial symptoms include fever, rash, red eyes, diarrhea, and vomiting that appear 2-6 weeks post COVID-19 infection. Like HSP, MIS-C can present with edema of the extremities, worsening hand/foot pain, and hematuria; however, the absence of both fever and the pattern of system involvement seen with MIS-C and classic findings in this patient are more consistent with HSP.
Reactive infectious mucocutaneous eruption (RIME) was recently coined to encompass both infection-associated Stevens-Johnson eruptions including Mycoplasma pneumoniae-induced rash and mucositis (MIRM) and mucocutaneous eruptions caused by nonmycoplasma pathogens (including Chlamydia pneumoniae, human parainfluenza virus 2, rhinovirus, adenovirus, enterovirus, human metapneumovirus, influenza B virus, and COVID-19). It is usually seen in male children and adolescents. Prodromal symptoms include cough, fever, and malaise and they precede the prominent feature of mucositis. Our patient’s lack of mucosal involvement is not consistent with RIME.
Perniosis (chilblains) is characterized by localized edematous patches of erythema or cyanosis on exposed extremities, that may be associated with cold exposure. Lesions are usually symmetric and self-limiting, and symptoms can include numbness, tingling, pruritus, burning, or pain. Pernio-like skin lesions have been seen during the COVID-19 pandemic, though many patients have negative testing for infection by PCR and serology. Pernio may also be seen with autoimmune diseases or malignancy.
Meningococcemia is a rare disease caused by infection with gram-negative diplococci bacteria Neisseria meningitidis and spreads through saliva or respiratory secretions. Its clinical presentation can vary widely, from transient fever to fulminant disease. It is characterized by upper respiratory tract infection, fever, and petechial lesions associated with thrombocytopenia and coagulopathy.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Laborada is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Laborada have no relevant financial disclosures.
References
AlGhoozi DA, AlKhayyat HM. BMJ Case Reports CP 2021;14:e239910.
Jacobi M et al. Pediatr Infect Dis J. 2021;40(2):e93-4.
Paller A, Mancini AJ. Hurwitz clinical pediatric dermatology: A textbook of skin disorders of childhood and adolescence. 4th ed. Philadelphia (PA): Elsevier Saunders; 2011.
Radia T et al. Paediatr Respir Rev. 2021;38:51-7.
Ramien ML. Clin Exp Dermatol. 2021;46(3):420-9.
Numerous morphologies of skin rashes have been described in the setting of COVID-19, including pernio, livedoid rash, exanthem, and vasculitis. This classic constellation of symptoms (palpable purpura on buttocks/legs, abdominal pain, arthralgia, hematuria) is highly consistent with Henoch-Schonlein purpura (HSP). There are now multiple case reports of COVID-19–associated HSP.
HSP is the most common type of childhood systemic vasculitis. It is mediated by immunoglobulin A (IgA) immune complex deposition and has been associated with respiratory tract infections, streptococcal species, parainfluenza virus, and human parvovirus B19, medications, vaccinations, and malignancies. HSP is usually a self-limiting disease, with a course over 4-6 weeks, and can affect multiple organs, including the skin, gastrointestinal tract, joints, and the kidneys. The diagnostic criteria include palpable purpura in the presence of one or more of the following: diffuse abdominal pain, arthritis or arthralgia, any biopsy showing predominant IgA deposition, and renal involvement in the form of hematuria or proteinuria. Renal disease is variable and is the most significant indicator of long-term prognosis. This teenager was treated with oral corticosteroids because of the severe periarticular edema and responded rapidly. His subsequent urine analyses normalized.
What is on the differential?
Multisystem inflammatory syndrome in children (MIS-C) is a rare, potentially fatal, complication of COVID-19 infection that causes inflammation of multiple organs, including the heart, lungs, kidneys, brain, skin, eyes, or the gastrointestinal tract. It commonly affects children around ages 8-9 years. Initial symptoms include fever, rash, red eyes, diarrhea, and vomiting that appear 2-6 weeks post COVID-19 infection. Like HSP, MIS-C can present with edema of the extremities, worsening hand/foot pain, and hematuria; however, the absence of both fever and the pattern of system involvement seen with MIS-C and classic findings in this patient are more consistent with HSP.
Reactive infectious mucocutaneous eruption (RIME) was recently coined to encompass both infection-associated Stevens-Johnson eruptions including Mycoplasma pneumoniae-induced rash and mucositis (MIRM) and mucocutaneous eruptions caused by nonmycoplasma pathogens (including Chlamydia pneumoniae, human parainfluenza virus 2, rhinovirus, adenovirus, enterovirus, human metapneumovirus, influenza B virus, and COVID-19). It is usually seen in male children and adolescents. Prodromal symptoms include cough, fever, and malaise and they precede the prominent feature of mucositis. Our patient’s lack of mucosal involvement is not consistent with RIME.
Perniosis (chilblains) is characterized by localized edematous patches of erythema or cyanosis on exposed extremities, that may be associated with cold exposure. Lesions are usually symmetric and self-limiting, and symptoms can include numbness, tingling, pruritus, burning, or pain. Pernio-like skin lesions have been seen during the COVID-19 pandemic, though many patients have negative testing for infection by PCR and serology. Pernio may also be seen with autoimmune diseases or malignancy.
Meningococcemia is a rare disease caused by infection with gram-negative diplococci bacteria Neisseria meningitidis and spreads through saliva or respiratory secretions. Its clinical presentation can vary widely, from transient fever to fulminant disease. It is characterized by upper respiratory tract infection, fever, and petechial lesions associated with thrombocytopenia and coagulopathy.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Laborada is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Laborada have no relevant financial disclosures.
References
AlGhoozi DA, AlKhayyat HM. BMJ Case Reports CP 2021;14:e239910.
Jacobi M et al. Pediatr Infect Dis J. 2021;40(2):e93-4.
Paller A, Mancini AJ. Hurwitz clinical pediatric dermatology: A textbook of skin disorders of childhood and adolescence. 4th ed. Philadelphia (PA): Elsevier Saunders; 2011.
Radia T et al. Paediatr Respir Rev. 2021;38:51-7.
Ramien ML. Clin Exp Dermatol. 2021;46(3):420-9.
Step right up, folks, for a public dissection
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
Enriched infant formula offers no academic benefit later: Study
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
FROM THE BMJ
What does it mean to be a trustworthy male ally?
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
Hormone blocker sticker shock – again – as patients lose cheaper drug option
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Drug combo at outset of polyarticular JIA benefits patients most
Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.
“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”
Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.
Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.
“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
Study details
The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:
- A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
- An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
- A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.
The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).
At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.
There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
Moving from step-up therapy to early-combination treatment
Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.
”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”
Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.
While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”
The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.
”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”
Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.
The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.
Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.
“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”
Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.
Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.
“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
Study details
The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:
- A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
- An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
- A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.
The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).
At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.
There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
Moving from step-up therapy to early-combination treatment
Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.
”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”
Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.
While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”
The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.
”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”
Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.
The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.
Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.
“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”
Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.
Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.
“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
Study details
The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:
- A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
- An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
- A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.
The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).
At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.
There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
Moving from step-up therapy to early-combination treatment
Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.
”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”
Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.
While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”
The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.
”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”
Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.
The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.
FROM ACR 2021
Children and COVID: New cases up again after dropping for 8 weeks
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
Breast milk of COVID-19–infected mothers helps build infant’s immune defenses
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
FROM JAMA NETWORK OPEN