Marcia Frellick

A CDC advisory panel recommended on Jan. 5 that 12- to 17-year-olds in the U.S. should get the Pfizer COVID-19 booster shot 5 months after a primary series of vaccinations.

The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.

The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.

The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.

The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.

The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.

The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.

The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.

She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”

Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”

She said vaccinating the unvaccinated must be the priority.

“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.

Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.

Dr. Brooks said extending the population for boosters is another tool in the toolbox.

“If it’s a hammer, we should hit that nail hard,” he said.

Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.

She noted the soaring Omicron cases.

“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.

Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.

“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.

“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”

Discussion of risk centered on myocarditis.

Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”

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

A CDC advisory panel recommended on Jan. 5 that 12- to 17-year-olds in the U.S. should get the Pfizer COVID-19 booster shot 5 months after a primary series of vaccinations.

The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.

The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.

The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.

The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.

The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.

The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.

The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.

She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”

Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”

She said vaccinating the unvaccinated must be the priority.

“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.

Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.

Dr. Brooks said extending the population for boosters is another tool in the toolbox.

“If it’s a hammer, we should hit that nail hard,” he said.

Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.

She noted the soaring Omicron cases.

“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.

Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.

“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.

“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”

Discussion of risk centered on myocarditis.

Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”

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

A CDC advisory panel recommended on Jan. 5 that 12- to 17-year-olds in the U.S. should get the Pfizer COVID-19 booster shot 5 months after a primary series of vaccinations.

The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.

The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.

The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.

The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.

The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.

The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.

The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.

She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”

Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”

She said vaccinating the unvaccinated must be the priority.

“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.

Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.

Dr. Brooks said extending the population for boosters is another tool in the toolbox.

“If it’s a hammer, we should hit that nail hard,” he said.

Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.

She noted the soaring Omicron cases.

“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.

Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.

“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.

“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”

Discussion of risk centered on myocarditis.

Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”

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

An obesity prevention program targeted at parents of infants benefited not only firstborn infants but their second-born siblings as well, a new study suggests.

According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.

The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.

Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.

The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.

Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.

Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.

Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m² lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m² lower.

“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.

“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.

He noted that this happened with second children without any reinforcements or booster information.

Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.

Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.

Weighing the costs of the intervention

The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.

But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.

“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.

Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”

However, he acknowledged that staff shortages and costs are a challenge.

“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”

Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.

Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.

Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.

Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.

“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.

Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
 

‘Promising’ findings

Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”

It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.

Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.

Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.

Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.

He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.

“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”

Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.

The paper’s authors and Dr. Wood declared no relevant financial relationships.

This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.

An obesity prevention program targeted at parents of infants benefited not only firstborn infants but their second-born siblings as well, a new study suggests.

According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.

The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.

Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.

The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.

Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.

Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.

Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m² lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m² lower.

“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.

“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.

He noted that this happened with second children without any reinforcements or booster information.

Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.

Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.

Weighing the costs of the intervention

The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.

But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.

“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.

Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”

However, he acknowledged that staff shortages and costs are a challenge.

“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”

Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.

Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.

Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.

Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.

“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.

Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
 

‘Promising’ findings

Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”

It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.

Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.

Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.

Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.

He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.

“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”

Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.

The paper’s authors and Dr. Wood declared no relevant financial relationships.

This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.

An obesity prevention program targeted at parents of infants benefited not only firstborn infants but their second-born siblings as well, a new study suggests.

According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.

The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.

Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.

The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.

Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.

Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.

Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m² lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m² lower.

“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.

“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.

He noted that this happened with second children without any reinforcements or booster information.

Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.

Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.

Weighing the costs of the intervention

The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.

But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.

“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.

Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”

However, he acknowledged that staff shortages and costs are a challenge.

“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”

Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.

Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.

Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.

Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.

“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.

Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
 

‘Promising’ findings

Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”

It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.

Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.

Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.

Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.

He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.

“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”

Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.

The paper’s authors and Dr. Wood declared no relevant financial relationships.

This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo (Ont.), found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings have not been peer reviewed.

The study included a representative cohort of 1,958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors noted that the survey was conducted from Sept. 28 to Oct. 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey. It included equal representation of vaccinated and vaccine-hesitant adults aged 18-54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.
 

Dose-response relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their noninfected counterparts (mechanical adjustment, 1.63, standard error, 0.08; 95% confidence interval, 1.47-1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

“This reinforces what we’re hearing about – that COVID is not ‘one and done.’ It can have lasting and quite subtle and damaging effects on the human body,” William Schaffner, MD, infectious disease specialist with Vanderbilt University, Nashville, Tenn., said in an interview.

Measuring executive functioning – including the ability to make sound decisions – is something other studies haven’t typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (beta, 0.15; P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (beta, 0.30; P < .001).

Dr. Schaffner said it was troubling that young people are more likely to experience the dysfunction.

“When we think of ‘brain fog’ we think of older persons who are already predisposed to have more memory lapses as they get older,” he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results with noninfected controls in the general population, the authors wrote.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:
 

• “I am unable to inhibit my reactions or responses to events or to other people.”
• “I make impulsive comments to others.”
• “I am likely to do things without considering the consequences for doing them.”
• “I act without thinking.”

“This makes it even more important that we talk about vaccination,” Dr. Schaffner said, “because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness. It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious.”

This research was supported by a grant from the Canadian Institutes for Health Research, Institute for Population and Public Health. The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

Margin marking before endoscopic mucosal resection (EMR) of large colorectal polyps cut the risk of recurrence by 80% when compared with traditional EMR, new data suggest.

A team of researchers, led by Dennis Yang, MD, with the Center for Interventional Endoscopy at AdventHealth, Orlando, compared polyp recurrence after patients received EMR with margin marking versus recurrence after conventional EMR in a historical control group. They conclude that the simple margin-marking strategy may offer an alternative to margin ablation.

The findings of the study were published online Nov. 29 in Gastrointestinal Endoscopy.

A single-center, historical control study

A total of 210 patients (average age, 66 years; 56.2% women) with 210 polyps (average size, 30 mm; interquartile range: 25-40 mm) had either EMR with margin marking (EMR-MM; n = 74) or conventional EMR (n = 136). The groups had similar patient and lesion characteristics.

For EMR-MM, cautery marks were drawn along the lateral margins of the polyp with the snare tip. EMR followed with resection of the healthy mucosa with the marks.

Physicians can confirm complete resection, including a healthy margin, when no cautery marks are visible after EMR, the authors write.

A follow-up colonoscopy was performed 3 to 6 months later, the results of which were compared against historical controls.

After 6 months, EMR-MM led to a lower recurrence rate compared with the historical control group with traditional EMR (8% vs. 29%, respectively; P < .001).

“This strategy allowed a more reliable wide-field EMR, which may account for why our preliminary results demonstrated an 80% reduction in the likelihood of recurrence even after controlling for other factors, including polyp size and histopathology,” the authors write.

Recurrence risk has been one of the main limitations of EMR compared with surgery, with rates from 10%-35%, the authors note, though it has fewer adverse reactions and offers better quality of life than surgery.

Dr. Yang told this news organization that multiple studies have looked at possible factors for recurrence, which is thought to primarily occur at the lateral resection margins of the polyp.

“That’s based on recent data that has shown that burning the resection margins after you actually take the lesion out reduces recurrence,” he said. “What that indirectly implies is that whenever we resect something, we may think we’ve got the entire lesion at the lateral margins, but we don’t.”

As Dr. Yang described, it was this implication that led to the premise of the study.

“If we were to somehow put visible marks outside the margins of the lesion, the marks would serve as visible cues to tell us how much more tissue we needed to resect and thereby help us get a more reliable way of ensuring clean resection margins.”

Dr. Yang and colleagues also found that EMR-MM was not linked with an increase in adverse events. On multivariable analysis, EMR-MM was the main predictor of recurrence (odds ratio, 0.20; 95% CI, 0.13-0.64; P = .003) aside from polyp size (OR, 2.81; 95% CI, 1.35-6.01; P = .008).

Expert: standard of care likely still better

Gastroenterologist Douglas Rex, MD, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Indianapolis, who was not involved in the study, told this news organization that he is not convinced that it is necessary or wise to use the margin-marking technique described in the paper over the current standard of care.

Dr. Rex explained that presently, physicians inject large lesions submucosally with fluid colored for contrast to delineate the margin of the polyp. This raises the question: if you can see the lesion well with that method, do you need to place the marks before you start around the border on the normal mucosa, as they did for the margin-marking group in this study?

Dr. Rex also noted that the researchers’ 29% control group recurrence rate is relatively high.

“Most of the evidence – if you look at the big meta-analyses – suggests that the recurrence rate with traditional methods is around 15%,” he said.

He added that even the recurrence rate in the current study’s active treatment arm is much higher than the 2%-5% rate seen in recent thermal ablation trials by Klein and colleagues and Sidhu and colleagues, both published in Gastroenterology.

“The methods described in those two papers should be considered the current standard of care,” Dr. Rex said. “Neither one of those involves this [margin-marking] method.”

Dr. Yang agrees that the Klein and Sidhu trials represent the standard of care, but he says it’s important to note that the 2% recurrence may not represent the actual practice of endoscopists of all skill levels.

“These are highly controlled studies coming from very experienced endoscopists,” he said.

“Our data are not trying to supplant what the high-quality studies on thermal ablation have shown. The point is to show that this is a concept that could potentially help,” he said.

“What I’m proposing is a potential alternative that could be better than that. Obviously, we won’t know until a comparative type of trial is performed.”

On that point, Dr. Yang and Dr. Rex agree.

Dr. Rex said that a randomized control trial would clarify some points and be useful to compare margin marking directly with the current standard of care, “which is to remove the whole thing and then burn up the margin.”

“Based on what we have seen so far, I would predict the current standard of care would have a very good chance of winning in terms of efficacy, because it’s hard to get lower than 2% [recurrence],” he said. “And it might well win with regard to safety, because burning the margin is at least theoretically safer than what they’re doing here.”

Dr. Rex said margin marking may be beneficial with the form of EMR that does not involve submucosal injection: underwater EMR. In underwater EMR, there’s no submucosal injection, and some people will mark the margin in those instances, he said.

“I do think it’s reasonable to do margin marking for underwater EMR,” Dr. Rex said.

Dr. Yang is a consultant for Boston Scientific, Olympus, Lumendi, and Steris. A coauthor is a consultant for Olympus, Boston Scientific, Cook Medical, Merit, Microtech, Steris, Lumendi, and Fujifilm. Another coauthor receives research grants from Steris and Cosmo/Aries Pharmaceuticals. Dr. Rex disclosed no relevant financial relationships.

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

Margin marking before endoscopic mucosal resection (EMR) of large colorectal polyps cut the risk of recurrence by 80% when compared with traditional EMR, new data suggest.

A team of researchers, led by Dennis Yang, MD, with the Center for Interventional Endoscopy at AdventHealth, Orlando, compared polyp recurrence after patients received EMR with margin marking versus recurrence after conventional EMR in a historical control group. They conclude that the simple margin-marking strategy may offer an alternative to margin ablation.

The findings of the study were published online Nov. 29 in Gastrointestinal Endoscopy.

A single-center, historical control study

A total of 210 patients (average age, 66 years; 56.2% women) with 210 polyps (average size, 30 mm; interquartile range: 25-40 mm) had either EMR with margin marking (EMR-MM; n = 74) or conventional EMR (n = 136). The groups had similar patient and lesion characteristics.

For EMR-MM, cautery marks were drawn along the lateral margins of the polyp with the snare tip. EMR followed with resection of the healthy mucosa with the marks.

Physicians can confirm complete resection, including a healthy margin, when no cautery marks are visible after EMR, the authors write.

A follow-up colonoscopy was performed 3 to 6 months later, the results of which were compared against historical controls.

After 6 months, EMR-MM led to a lower recurrence rate compared with the historical control group with traditional EMR (8% vs. 29%, respectively; P < .001).

“This strategy allowed a more reliable wide-field EMR, which may account for why our preliminary results demonstrated an 80% reduction in the likelihood of recurrence even after controlling for other factors, including polyp size and histopathology,” the authors write.

Recurrence risk has been one of the main limitations of EMR compared with surgery, with rates from 10%-35%, the authors note, though it has fewer adverse reactions and offers better quality of life than surgery.

Dr. Yang told this news organization that multiple studies have looked at possible factors for recurrence, which is thought to primarily occur at the lateral resection margins of the polyp.

“That’s based on recent data that has shown that burning the resection margins after you actually take the lesion out reduces recurrence,” he said. “What that indirectly implies is that whenever we resect something, we may think we’ve got the entire lesion at the lateral margins, but we don’t.”

As Dr. Yang described, it was this implication that led to the premise of the study.

“If we were to somehow put visible marks outside the margins of the lesion, the marks would serve as visible cues to tell us how much more tissue we needed to resect and thereby help us get a more reliable way of ensuring clean resection margins.”

Dr. Yang and colleagues also found that EMR-MM was not linked with an increase in adverse events. On multivariable analysis, EMR-MM was the main predictor of recurrence (odds ratio, 0.20; 95% CI, 0.13-0.64; P = .003) aside from polyp size (OR, 2.81; 95% CI, 1.35-6.01; P = .008).

Expert: standard of care likely still better

Gastroenterologist Douglas Rex, MD, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Indianapolis, who was not involved in the study, told this news organization that he is not convinced that it is necessary or wise to use the margin-marking technique described in the paper over the current standard of care.

Dr. Rex explained that presently, physicians inject large lesions submucosally with fluid colored for contrast to delineate the margin of the polyp. This raises the question: if you can see the lesion well with that method, do you need to place the marks before you start around the border on the normal mucosa, as they did for the margin-marking group in this study?

Dr. Rex also noted that the researchers’ 29% control group recurrence rate is relatively high.

“Most of the evidence – if you look at the big meta-analyses – suggests that the recurrence rate with traditional methods is around 15%,” he said.

He added that even the recurrence rate in the current study’s active treatment arm is much higher than the 2%-5% rate seen in recent thermal ablation trials by Klein and colleagues and Sidhu and colleagues, both published in Gastroenterology.

“The methods described in those two papers should be considered the current standard of care,” Dr. Rex said. “Neither one of those involves this [margin-marking] method.”

Dr. Yang agrees that the Klein and Sidhu trials represent the standard of care, but he says it’s important to note that the 2% recurrence may not represent the actual practice of endoscopists of all skill levels.

“These are highly controlled studies coming from very experienced endoscopists,” he said.

“Our data are not trying to supplant what the high-quality studies on thermal ablation have shown. The point is to show that this is a concept that could potentially help,” he said.

“What I’m proposing is a potential alternative that could be better than that. Obviously, we won’t know until a comparative type of trial is performed.”

On that point, Dr. Yang and Dr. Rex agree.

Dr. Rex said that a randomized control trial would clarify some points and be useful to compare margin marking directly with the current standard of care, “which is to remove the whole thing and then burn up the margin.”

“Based on what we have seen so far, I would predict the current standard of care would have a very good chance of winning in terms of efficacy, because it’s hard to get lower than 2% [recurrence],” he said. “And it might well win with regard to safety, because burning the margin is at least theoretically safer than what they’re doing here.”

Dr. Rex said margin marking may be beneficial with the form of EMR that does not involve submucosal injection: underwater EMR. In underwater EMR, there’s no submucosal injection, and some people will mark the margin in those instances, he said.

“I do think it’s reasonable to do margin marking for underwater EMR,” Dr. Rex said.

Dr. Yang is a consultant for Boston Scientific, Olympus, Lumendi, and Steris. A coauthor is a consultant for Olympus, Boston Scientific, Cook Medical, Merit, Microtech, Steris, Lumendi, and Fujifilm. Another coauthor receives research grants from Steris and Cosmo/Aries Pharmaceuticals. Dr. Rex disclosed no relevant financial relationships.

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

Margin marking before endoscopic mucosal resection (EMR) of large colorectal polyps cut the risk of recurrence by 80% when compared with traditional EMR, new data suggest.

A team of researchers, led by Dennis Yang, MD, with the Center for Interventional Endoscopy at AdventHealth, Orlando, compared polyp recurrence after patients received EMR with margin marking versus recurrence after conventional EMR in a historical control group. They conclude that the simple margin-marking strategy may offer an alternative to margin ablation.

The findings of the study were published online Nov. 29 in Gastrointestinal Endoscopy.

A single-center, historical control study

A total of 210 patients (average age, 66 years; 56.2% women) with 210 polyps (average size, 30 mm; interquartile range: 25-40 mm) had either EMR with margin marking (EMR-MM; n = 74) or conventional EMR (n = 136). The groups had similar patient and lesion characteristics.

For EMR-MM, cautery marks were drawn along the lateral margins of the polyp with the snare tip. EMR followed with resection of the healthy mucosa with the marks.

Physicians can confirm complete resection, including a healthy margin, when no cautery marks are visible after EMR, the authors write.

A follow-up colonoscopy was performed 3 to 6 months later, the results of which were compared against historical controls.

After 6 months, EMR-MM led to a lower recurrence rate compared with the historical control group with traditional EMR (8% vs. 29%, respectively; P < .001).

“This strategy allowed a more reliable wide-field EMR, which may account for why our preliminary results demonstrated an 80% reduction in the likelihood of recurrence even after controlling for other factors, including polyp size and histopathology,” the authors write.

Recurrence risk has been one of the main limitations of EMR compared with surgery, with rates from 10%-35%, the authors note, though it has fewer adverse reactions and offers better quality of life than surgery.

Dr. Yang told this news organization that multiple studies have looked at possible factors for recurrence, which is thought to primarily occur at the lateral resection margins of the polyp.

“That’s based on recent data that has shown that burning the resection margins after you actually take the lesion out reduces recurrence,” he said. “What that indirectly implies is that whenever we resect something, we may think we’ve got the entire lesion at the lateral margins, but we don’t.”

As Dr. Yang described, it was this implication that led to the premise of the study.

“If we were to somehow put visible marks outside the margins of the lesion, the marks would serve as visible cues to tell us how much more tissue we needed to resect and thereby help us get a more reliable way of ensuring clean resection margins.”

Dr. Yang and colleagues also found that EMR-MM was not linked with an increase in adverse events. On multivariable analysis, EMR-MM was the main predictor of recurrence (odds ratio, 0.20; 95% CI, 0.13-0.64; P = .003) aside from polyp size (OR, 2.81; 95% CI, 1.35-6.01; P = .008).

Expert: standard of care likely still better

Gastroenterologist Douglas Rex, MD, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Indianapolis, who was not involved in the study, told this news organization that he is not convinced that it is necessary or wise to use the margin-marking technique described in the paper over the current standard of care.

Dr. Rex explained that presently, physicians inject large lesions submucosally with fluid colored for contrast to delineate the margin of the polyp. This raises the question: if you can see the lesion well with that method, do you need to place the marks before you start around the border on the normal mucosa, as they did for the margin-marking group in this study?

Dr. Rex also noted that the researchers’ 29% control group recurrence rate is relatively high.

“Most of the evidence – if you look at the big meta-analyses – suggests that the recurrence rate with traditional methods is around 15%,” he said.

He added that even the recurrence rate in the current study’s active treatment arm is much higher than the 2%-5% rate seen in recent thermal ablation trials by Klein and colleagues and Sidhu and colleagues, both published in Gastroenterology.

“The methods described in those two papers should be considered the current standard of care,” Dr. Rex said. “Neither one of those involves this [margin-marking] method.”

Dr. Yang agrees that the Klein and Sidhu trials represent the standard of care, but he says it’s important to note that the 2% recurrence may not represent the actual practice of endoscopists of all skill levels.

“These are highly controlled studies coming from very experienced endoscopists,” he said.

“Our data are not trying to supplant what the high-quality studies on thermal ablation have shown. The point is to show that this is a concept that could potentially help,” he said.

“What I’m proposing is a potential alternative that could be better than that. Obviously, we won’t know until a comparative type of trial is performed.”

On that point, Dr. Yang and Dr. Rex agree.

Dr. Rex said that a randomized control trial would clarify some points and be useful to compare margin marking directly with the current standard of care, “which is to remove the whole thing and then burn up the margin.”

“Based on what we have seen so far, I would predict the current standard of care would have a very good chance of winning in terms of efficacy, because it’s hard to get lower than 2% [recurrence],” he said. “And it might well win with regard to safety, because burning the margin is at least theoretically safer than what they’re doing here.”

Dr. Rex said margin marking may be beneficial with the form of EMR that does not involve submucosal injection: underwater EMR. In underwater EMR, there’s no submucosal injection, and some people will mark the margin in those instances, he said.

“I do think it’s reasonable to do margin marking for underwater EMR,” Dr. Rex said.

Dr. Yang is a consultant for Boston Scientific, Olympus, Lumendi, and Steris. A coauthor is a consultant for Olympus, Boston Scientific, Cook Medical, Merit, Microtech, Steris, Lumendi, and Fujifilm. Another coauthor receives research grants from Steris and Cosmo/Aries Pharmaceuticals. Dr. Rex disclosed no relevant financial relationships.

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

Severe gastrointestinal involvement can be common in children who have had COVID-19, a new study shows.

Andrea Lo Veccio, MD, PhD, with the department of translational medical sciences, section of pediatrics, University of Naples (Italy) Federico II, and colleagues retrospectively analyzed data from a large cohort of children aged 18 years and younger who had been diagnosed with COVID-19 between Feb. 25, 2020, and Jan. 20, 2021, in 54 Italian institutions.

Overall, 685 Italian children (56.4% boys; average age, 7 years) were included in the study. Of these, 628 (91.7%) were diagnosed with acute SARS-CoV-2 infection and 57 (8.3%) with multisystem inflammatory syndrome in children (MIS-C).

When children had GI symptoms, the authors found a higher risk of hospitalization (odds ratio, 2.64; 95% confidence interval, 1.89-3.69) and nearly four times the risk of ICU admission (OR, 3.90; 95% CI, 1.98-7.68).

Severe GI involvement occurred in 65 children (9.5%). The authors included the following within that category: disseminated adenomesenteritis (39.6%), appendicitis (33.5%), abdominal fluid collection (21.3%), pancreatitis (6.9%), or intussusception (4.6%). Additionally, out of these 65 children, 27 (41.5%) underwent surgery.

Older children were much more likely than preschoolers to have severe GI symptoms. Children aged 5-10 years were eight times more likely than preschoolers to show severe symptoms (OR, 8.33; 95% CI, 2.62-26.5). In those older than age 10 years, severe symptoms were six times more likely (OR, 6.37; 95% CI, 2.12-19.1).

Awareness about its frequency and presentation may help practitioners to appropriately manage children at risk of severe outcomes, the authors wrote.

The findings of this study were published online Dec. 20 in JAMA Network Open.
 

Study highlights the GI link

Reached for comment, William Balistreri, MD, with the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital Medical Center, said that it has been known that children are more likely than adults to present with GI symptoms, and also that these symptoms are especially common in children with MIS-C.

“The symptoms most commonly cited in the literature to date include diarrhea, nausea, vomiting, or abdominal pain,” he said. “What [has not been known] is the frequency, predictive markers, and clinical course of the severe GI manifestations of COVID-19.”

The findings of this study are important to clinicians to help recognize the potential for severe GI involvement, Dr. Balistreri said, adding that “the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers or MIS-C should raise suspicion and lead to early evaluation.”

Margaret E. Thew, APNP, medical director in adolescent medicine and a family nurse practitioner with Medical College of Wisconsin, Milwaukee, said that news reports typically emphasize the respiratory involvement, but this study provides a detailed analysis of the link between GI symptoms and COVID-19.

“Their data show that there may be less respiratory illness with children, regardless of whether they are generally healthy kids,” she said. “They may have more GI symptoms.

“We know that COVID-19 causes a lot of inflammation, and a large percentage of these kids had inflammation in their stomach or an inflamed bowel,” she added.

Dr. Thew said primary care doctors and urgent and emergency care clinicians will benefit from the findings of this study and should be on alert when kids come in with belly pain or vomiting.

Parents will benefit too, she said, if they are waiting for respiratory illness before they suspect COVID.

“You have to have a high suspicion this is going to be COVID positive,” she said. “You have to have that as part of your thought process.”

Though the study was done in Italy, Dr. Thew added that their experiences mimic those she’s seen locally.

Dr. Lo Vecchio reported receiving fees from Pfizer as an advisory board member outside the submitted work. A coauthor reported speaker’s fees from Angelini, Sobi, and X4 Pharma outside the submitted work. No other disclosures were reported. Dr. Balistreri and Dr. Thew reported no relevant financial relationships.

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

Severe gastrointestinal involvement can be common in children who have had COVID-19, a new study shows.

Andrea Lo Veccio, MD, PhD, with the department of translational medical sciences, section of pediatrics, University of Naples (Italy) Federico II, and colleagues retrospectively analyzed data from a large cohort of children aged 18 years and younger who had been diagnosed with COVID-19 between Feb. 25, 2020, and Jan. 20, 2021, in 54 Italian institutions.

Overall, 685 Italian children (56.4% boys; average age, 7 years) were included in the study. Of these, 628 (91.7%) were diagnosed with acute SARS-CoV-2 infection and 57 (8.3%) with multisystem inflammatory syndrome in children (MIS-C).

When children had GI symptoms, the authors found a higher risk of hospitalization (odds ratio, 2.64; 95% confidence interval, 1.89-3.69) and nearly four times the risk of ICU admission (OR, 3.90; 95% CI, 1.98-7.68).

Severe GI involvement occurred in 65 children (9.5%). The authors included the following within that category: disseminated adenomesenteritis (39.6%), appendicitis (33.5%), abdominal fluid collection (21.3%), pancreatitis (6.9%), or intussusception (4.6%). Additionally, out of these 65 children, 27 (41.5%) underwent surgery.

Older children were much more likely than preschoolers to have severe GI symptoms. Children aged 5-10 years were eight times more likely than preschoolers to show severe symptoms (OR, 8.33; 95% CI, 2.62-26.5). In those older than age 10 years, severe symptoms were six times more likely (OR, 6.37; 95% CI, 2.12-19.1).

Awareness about its frequency and presentation may help practitioners to appropriately manage children at risk of severe outcomes, the authors wrote.

The findings of this study were published online Dec. 20 in JAMA Network Open.
 

Study highlights the GI link

Reached for comment, William Balistreri, MD, with the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital Medical Center, said that it has been known that children are more likely than adults to present with GI symptoms, and also that these symptoms are especially common in children with MIS-C.

“The symptoms most commonly cited in the literature to date include diarrhea, nausea, vomiting, or abdominal pain,” he said. “What [has not been known] is the frequency, predictive markers, and clinical course of the severe GI manifestations of COVID-19.”

The findings of this study are important to clinicians to help recognize the potential for severe GI involvement, Dr. Balistreri said, adding that “the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers or MIS-C should raise suspicion and lead to early evaluation.”

Margaret E. Thew, APNP, medical director in adolescent medicine and a family nurse practitioner with Medical College of Wisconsin, Milwaukee, said that news reports typically emphasize the respiratory involvement, but this study provides a detailed analysis of the link between GI symptoms and COVID-19.

“Their data show that there may be less respiratory illness with children, regardless of whether they are generally healthy kids,” she said. “They may have more GI symptoms.

“We know that COVID-19 causes a lot of inflammation, and a large percentage of these kids had inflammation in their stomach or an inflamed bowel,” she added.

Dr. Thew said primary care doctors and urgent and emergency care clinicians will benefit from the findings of this study and should be on alert when kids come in with belly pain or vomiting.

Parents will benefit too, she said, if they are waiting for respiratory illness before they suspect COVID.

“You have to have a high suspicion this is going to be COVID positive,” she said. “You have to have that as part of your thought process.”

Though the study was done in Italy, Dr. Thew added that their experiences mimic those she’s seen locally.

Dr. Lo Vecchio reported receiving fees from Pfizer as an advisory board member outside the submitted work. A coauthor reported speaker’s fees from Angelini, Sobi, and X4 Pharma outside the submitted work. No other disclosures were reported. Dr. Balistreri and Dr. Thew reported no relevant financial relationships.

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

Severe gastrointestinal involvement can be common in children who have had COVID-19, a new study shows.

Andrea Lo Veccio, MD, PhD, with the department of translational medical sciences, section of pediatrics, University of Naples (Italy) Federico II, and colleagues retrospectively analyzed data from a large cohort of children aged 18 years and younger who had been diagnosed with COVID-19 between Feb. 25, 2020, and Jan. 20, 2021, in 54 Italian institutions.

Overall, 685 Italian children (56.4% boys; average age, 7 years) were included in the study. Of these, 628 (91.7%) were diagnosed with acute SARS-CoV-2 infection and 57 (8.3%) with multisystem inflammatory syndrome in children (MIS-C).

When children had GI symptoms, the authors found a higher risk of hospitalization (odds ratio, 2.64; 95% confidence interval, 1.89-3.69) and nearly four times the risk of ICU admission (OR, 3.90; 95% CI, 1.98-7.68).

Severe GI involvement occurred in 65 children (9.5%). The authors included the following within that category: disseminated adenomesenteritis (39.6%), appendicitis (33.5%), abdominal fluid collection (21.3%), pancreatitis (6.9%), or intussusception (4.6%). Additionally, out of these 65 children, 27 (41.5%) underwent surgery.

Older children were much more likely than preschoolers to have severe GI symptoms. Children aged 5-10 years were eight times more likely than preschoolers to show severe symptoms (OR, 8.33; 95% CI, 2.62-26.5). In those older than age 10 years, severe symptoms were six times more likely (OR, 6.37; 95% CI, 2.12-19.1).

Awareness about its frequency and presentation may help practitioners to appropriately manage children at risk of severe outcomes, the authors wrote.

The findings of this study were published online Dec. 20 in JAMA Network Open.
 

Study highlights the GI link

Reached for comment, William Balistreri, MD, with the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital Medical Center, said that it has been known that children are more likely than adults to present with GI symptoms, and also that these symptoms are especially common in children with MIS-C.

“The symptoms most commonly cited in the literature to date include diarrhea, nausea, vomiting, or abdominal pain,” he said. “What [has not been known] is the frequency, predictive markers, and clinical course of the severe GI manifestations of COVID-19.”

The findings of this study are important to clinicians to help recognize the potential for severe GI involvement, Dr. Balistreri said, adding that “the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers or MIS-C should raise suspicion and lead to early evaluation.”

Margaret E. Thew, APNP, medical director in adolescent medicine and a family nurse practitioner with Medical College of Wisconsin, Milwaukee, said that news reports typically emphasize the respiratory involvement, but this study provides a detailed analysis of the link between GI symptoms and COVID-19.

“Their data show that there may be less respiratory illness with children, regardless of whether they are generally healthy kids,” she said. “They may have more GI symptoms.

“We know that COVID-19 causes a lot of inflammation, and a large percentage of these kids had inflammation in their stomach or an inflamed bowel,” she added.

Dr. Thew said primary care doctors and urgent and emergency care clinicians will benefit from the findings of this study and should be on alert when kids come in with belly pain or vomiting.

Parents will benefit too, she said, if they are waiting for respiratory illness before they suspect COVID.

“You have to have a high suspicion this is going to be COVID positive,” she said. “You have to have that as part of your thought process.”

Though the study was done in Italy, Dr. Thew added that their experiences mimic those she’s seen locally.

Dr. Lo Vecchio reported receiving fees from Pfizer as an advisory board member outside the submitted work. A coauthor reported speaker’s fees from Angelini, Sobi, and X4 Pharma outside the submitted work. No other disclosures were reported. Dr. Balistreri and Dr. Thew reported no relevant financial relationships.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

International guidelines developed to help nonspecialists diagnose cow’s milk allergy (CMA) lead providers to attribute normal infant symptoms to CMA and result in overdiagnosis, say authors of a study published online in Clinical & Experimental Allergy.

Lead author Rosie Vincent, MBChB, with Population Health Sciences at University of Bristol, United Kingdom, told this news organization their study shows that symptoms listed in the international Milk Allergy in Primary Care (iMAP) guidelines as indicative of non-immunoglobulin E (IgE)-mediated milk allergy are very common in a baby’s first year. Examples include vomiting, regurgitating milk, loose or more frequent stools, colic, and irritability.

Findings come from performing a secondary analysis of data from 1,303 infants from the EAT study, a population-based, randomized controlled trial in the U.K. that looked at whether introducing allergenic foods into an infant’s diet reduced the risk of developing an allergy to that food.

In an indication of how common the symptoms in the guidelines (published in 2017 and 2019) are found in all infants, nearly three-fourths (74%) of participants reported at least two mild-to-moderate symptoms, and 9% reported at least two severe symptoms in at least one month between 3 and 12 months of age. Data were not available for younger infants.

However, the prevalence of non–IgE-mediated CMA is thought to be less than 1% in infants in European countries, the study states.

In the study, two or more non-IgE CMA mild-to-moderate symptoms were reported by 25% of families, and 1.4% reported severe symptoms each month between ages 3 and 12 months.

“These symptoms peaked at 38%, with at least two mild-to-moderate symptoms and 4.3% with at least two severe symptoms at 3 months, when participants were not directly consuming cow’s milk,” Ms. Vincent said.

Researchers write that at 6 months there was no significant difference in the proportion of children with at least two symptoms between those consuming and not consuming cow’s milk.
 

Consequences of misdiagnosis

Overdiagnosing milk allergy can lead to additional costs, unnecessary tests, and less breastfeeding, she said.

Cow’s milk protein is commonly found in standard infant formula or in milk-containing foods.

The authors note that “small levels of lactoglobulin are found in breastmilk; however, the quantities are below the threshold likely to trigger a reaction in more than 99% of infants with IgE-mediated cow’s milk allergy.”

Misdiagnosis is likely to result in increasing prescriptions of unwarranted specialized formula, with increased cost to patients and health care systems, and use of unvalidated allergy tests, Ms. Vincent said.

Ms. Vincent added that even the suggestion that cow’s milk protein delivered through breast milk might be inducing symptoms could lead a mother to stop breastfeeding.

The authors also note that in reviewing recent CMA guidelines, “three of nine CMA guidelines were directly supported by formula manufacturers or marketing consultants, and 81% of all guideline authors reported a conflict of interest with formula manufacturers.”

Heather Cassell, MD, a pediatric allergy and immunology specialist with Banner Health and a clinical associate professor of pediatrics at the University of Arizona College of Medicine in Tucson, told this news organization the conflicts of interest in milk allergy research and guidelines have been a long-standing problem.

She said historically there has been a big push “that people who can afford formula should be paying for formula. That was 100% marketed by the formula companies.”

“We have formula companies bringing us samples to encourage pediatricians to use the formula early if we’re concerned about a milk protein allergy,” Dr. Cassell said.

As for the overdiagnosis of milk allergy, she said reintroduction of cow’s milk later is one way to improve diagnosis to see if the child no longer has a reaction. However, she points out that in this study, only 21% of parents reintroduced cow’s milk.

“Really, it should be closer to 100%, with the exception of the babies who are having severe symptoms,” Dr. Cassell said. “You don’t want to keep a baby from progressing with their diet.”

She said families and providers need to look at several contextual clues before they land on a milk allergy label.

“It’s not just about reflux, it’s not just about a baby spitting up. Happy babies spit up and there’s nothing that needs to be done because they will eventually grow out of it,” Dr. Cassell stressed.

She said significant irritability with blood in the stool might warrant more concern. “I think the [emphasis] needs to be on retrying the food another time,” she suggested.

Ms. Vincent pointed out that there is no quick or easy test to diagnose non–IgE-mediated cow’s milk allergy.

“We need further research to identify what symptoms are much more likely to point to a diagnosis,” she said.

Although the researchers used iMAP guidelines, they write that results are likely to apply to other CMA guidelines, because they list similar symptoms and signs.

The study was funded by the International Society of Atopic Dermatitis. Ms. Vincent reports receiving a 3-month research fellowship award from Pfizer and support from the NIHR School for Primary Care Research. Other authors’ financial disclosures are available with the full text. Dr. Cassell reports that the University of Arizona School of Medicine is a trial site for testing a patch to help with diagnosing milk protein allergy in infants.

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

International guidelines developed to help nonspecialists diagnose cow’s milk allergy (CMA) lead providers to attribute normal infant symptoms to CMA and result in overdiagnosis, say authors of a study published online in Clinical & Experimental Allergy.

Lead author Rosie Vincent, MBChB, with Population Health Sciences at University of Bristol, United Kingdom, told this news organization their study shows that symptoms listed in the international Milk Allergy in Primary Care (iMAP) guidelines as indicative of non-immunoglobulin E (IgE)-mediated milk allergy are very common in a baby’s first year. Examples include vomiting, regurgitating milk, loose or more frequent stools, colic, and irritability.

Findings come from performing a secondary analysis of data from 1,303 infants from the EAT study, a population-based, randomized controlled trial in the U.K. that looked at whether introducing allergenic foods into an infant’s diet reduced the risk of developing an allergy to that food.

In an indication of how common the symptoms in the guidelines (published in 2017 and 2019) are found in all infants, nearly three-fourths (74%) of participants reported at least two mild-to-moderate symptoms, and 9% reported at least two severe symptoms in at least one month between 3 and 12 months of age. Data were not available for younger infants.

However, the prevalence of non–IgE-mediated CMA is thought to be less than 1% in infants in European countries, the study states.

In the study, two or more non-IgE CMA mild-to-moderate symptoms were reported by 25% of families, and 1.4% reported severe symptoms each month between ages 3 and 12 months.

“These symptoms peaked at 38%, with at least two mild-to-moderate symptoms and 4.3% with at least two severe symptoms at 3 months, when participants were not directly consuming cow’s milk,” Ms. Vincent said.

Researchers write that at 6 months there was no significant difference in the proportion of children with at least two symptoms between those consuming and not consuming cow’s milk.
 

Consequences of misdiagnosis

Overdiagnosing milk allergy can lead to additional costs, unnecessary tests, and less breastfeeding, she said.

Cow’s milk protein is commonly found in standard infant formula or in milk-containing foods.

The authors note that “small levels of lactoglobulin are found in breastmilk; however, the quantities are below the threshold likely to trigger a reaction in more than 99% of infants with IgE-mediated cow’s milk allergy.”

Misdiagnosis is likely to result in increasing prescriptions of unwarranted specialized formula, with increased cost to patients and health care systems, and use of unvalidated allergy tests, Ms. Vincent said.

Ms. Vincent added that even the suggestion that cow’s milk protein delivered through breast milk might be inducing symptoms could lead a mother to stop breastfeeding.

The authors also note that in reviewing recent CMA guidelines, “three of nine CMA guidelines were directly supported by formula manufacturers or marketing consultants, and 81% of all guideline authors reported a conflict of interest with formula manufacturers.”

Heather Cassell, MD, a pediatric allergy and immunology specialist with Banner Health and a clinical associate professor of pediatrics at the University of Arizona College of Medicine in Tucson, told this news organization the conflicts of interest in milk allergy research and guidelines have been a long-standing problem.

She said historically there has been a big push “that people who can afford formula should be paying for formula. That was 100% marketed by the formula companies.”

“We have formula companies bringing us samples to encourage pediatricians to use the formula early if we’re concerned about a milk protein allergy,” Dr. Cassell said.

As for the overdiagnosis of milk allergy, she said reintroduction of cow’s milk later is one way to improve diagnosis to see if the child no longer has a reaction. However, she points out that in this study, only 21% of parents reintroduced cow’s milk.

“Really, it should be closer to 100%, with the exception of the babies who are having severe symptoms,” Dr. Cassell said. “You don’t want to keep a baby from progressing with their diet.”

She said families and providers need to look at several contextual clues before they land on a milk allergy label.

“It’s not just about reflux, it’s not just about a baby spitting up. Happy babies spit up and there’s nothing that needs to be done because they will eventually grow out of it,” Dr. Cassell stressed.

She said significant irritability with blood in the stool might warrant more concern. “I think the [emphasis] needs to be on retrying the food another time,” she suggested.

Ms. Vincent pointed out that there is no quick or easy test to diagnose non–IgE-mediated cow’s milk allergy.

“We need further research to identify what symptoms are much more likely to point to a diagnosis,” she said.

Although the researchers used iMAP guidelines, they write that results are likely to apply to other CMA guidelines, because they list similar symptoms and signs.

The study was funded by the International Society of Atopic Dermatitis. Ms. Vincent reports receiving a 3-month research fellowship award from Pfizer and support from the NIHR School for Primary Care Research. Other authors’ financial disclosures are available with the full text. Dr. Cassell reports that the University of Arizona School of Medicine is a trial site for testing a patch to help with diagnosing milk protein allergy in infants.

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

International guidelines developed to help nonspecialists diagnose cow’s milk allergy (CMA) lead providers to attribute normal infant symptoms to CMA and result in overdiagnosis, say authors of a study published online in Clinical & Experimental Allergy.

Lead author Rosie Vincent, MBChB, with Population Health Sciences at University of Bristol, United Kingdom, told this news organization their study shows that symptoms listed in the international Milk Allergy in Primary Care (iMAP) guidelines as indicative of non-immunoglobulin E (IgE)-mediated milk allergy are very common in a baby’s first year. Examples include vomiting, regurgitating milk, loose or more frequent stools, colic, and irritability.

Findings come from performing a secondary analysis of data from 1,303 infants from the EAT study, a population-based, randomized controlled trial in the U.K. that looked at whether introducing allergenic foods into an infant’s diet reduced the risk of developing an allergy to that food.

In an indication of how common the symptoms in the guidelines (published in 2017 and 2019) are found in all infants, nearly three-fourths (74%) of participants reported at least two mild-to-moderate symptoms, and 9% reported at least two severe symptoms in at least one month between 3 and 12 months of age. Data were not available for younger infants.

However, the prevalence of non–IgE-mediated CMA is thought to be less than 1% in infants in European countries, the study states.

In the study, two or more non-IgE CMA mild-to-moderate symptoms were reported by 25% of families, and 1.4% reported severe symptoms each month between ages 3 and 12 months.

“These symptoms peaked at 38%, with at least two mild-to-moderate symptoms and 4.3% with at least two severe symptoms at 3 months, when participants were not directly consuming cow’s milk,” Ms. Vincent said.

Researchers write that at 6 months there was no significant difference in the proportion of children with at least two symptoms between those consuming and not consuming cow’s milk.
 

Consequences of misdiagnosis

Overdiagnosing milk allergy can lead to additional costs, unnecessary tests, and less breastfeeding, she said.

Cow’s milk protein is commonly found in standard infant formula or in milk-containing foods.

The authors note that “small levels of lactoglobulin are found in breastmilk; however, the quantities are below the threshold likely to trigger a reaction in more than 99% of infants with IgE-mediated cow’s milk allergy.”

Misdiagnosis is likely to result in increasing prescriptions of unwarranted specialized formula, with increased cost to patients and health care systems, and use of unvalidated allergy tests, Ms. Vincent said.

Ms. Vincent added that even the suggestion that cow’s milk protein delivered through breast milk might be inducing symptoms could lead a mother to stop breastfeeding.

The authors also note that in reviewing recent CMA guidelines, “three of nine CMA guidelines were directly supported by formula manufacturers or marketing consultants, and 81% of all guideline authors reported a conflict of interest with formula manufacturers.”

Heather Cassell, MD, a pediatric allergy and immunology specialist with Banner Health and a clinical associate professor of pediatrics at the University of Arizona College of Medicine in Tucson, told this news organization the conflicts of interest in milk allergy research and guidelines have been a long-standing problem.

She said historically there has been a big push “that people who can afford formula should be paying for formula. That was 100% marketed by the formula companies.”

“We have formula companies bringing us samples to encourage pediatricians to use the formula early if we’re concerned about a milk protein allergy,” Dr. Cassell said.

As for the overdiagnosis of milk allergy, she said reintroduction of cow’s milk later is one way to improve diagnosis to see if the child no longer has a reaction. However, she points out that in this study, only 21% of parents reintroduced cow’s milk.

“Really, it should be closer to 100%, with the exception of the babies who are having severe symptoms,” Dr. Cassell said. “You don’t want to keep a baby from progressing with their diet.”

She said families and providers need to look at several contextual clues before they land on a milk allergy label.

“It’s not just about reflux, it’s not just about a baby spitting up. Happy babies spit up and there’s nothing that needs to be done because they will eventually grow out of it,” Dr. Cassell stressed.

She said significant irritability with blood in the stool might warrant more concern. “I think the [emphasis] needs to be on retrying the food another time,” she suggested.

Ms. Vincent pointed out that there is no quick or easy test to diagnose non–IgE-mediated cow’s milk allergy.

“We need further research to identify what symptoms are much more likely to point to a diagnosis,” she said.

Although the researchers used iMAP guidelines, they write that results are likely to apply to other CMA guidelines, because they list similar symptoms and signs.

The study was funded by the International Society of Atopic Dermatitis. Ms. Vincent reports receiving a 3-month research fellowship award from Pfizer and support from the NIHR School for Primary Care Research. Other authors’ financial disclosures are available with the full text. Dr. Cassell reports that the University of Arizona School of Medicine is a trial site for testing a patch to help with diagnosing milk protein allergy in infants.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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