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FDA delays action on Pfizer vaccine for kids under 5
for younger children until data on the effects of three doses is available.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”
Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”
“If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, predicted in January that the Pfizer vaccine for younger kids could be available this month. But, he also predicted three doses would be required.
Pfizer announced in mid-December that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.
A version of this article first appeared on WebMD.com.
for younger children until data on the effects of three doses is available.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”
Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”
“If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, predicted in January that the Pfizer vaccine for younger kids could be available this month. But, he also predicted three doses would be required.
Pfizer announced in mid-December that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.
A version of this article first appeared on WebMD.com.
for younger children until data on the effects of three doses is available.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the plan for a meeting the week of Feb. 14 of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”
Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Dr. Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”
“If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, predicted in January that the Pfizer vaccine for younger kids could be available this month. But, he also predicted three doses would be required.
Pfizer announced in mid-December that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.
A version of this article first appeared on WebMD.com.
Did you know these things about nicotine? Your patients don’t
When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.
Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.
Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.
Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.
If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.
We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.
Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.
While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.
How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.
Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.
Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.
Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Reference
Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.
When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.
Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.
Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.
Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.
If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.
We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.
Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.
While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.
How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.
Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.
Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.
Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Reference
Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.
When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.
Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.
Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.
Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.
If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.
We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.
Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.
While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.
How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.
Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.
Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.
Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Reference
Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.
Omicron death rate higher than during Delta surge
With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the Washington Post reported.
That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.
The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.
“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.
The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.
The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.
The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.
“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”
CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.
The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.
“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.
In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.
The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.
Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.
A version of this article first appeared on WebMD.com.
With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the Washington Post reported.
That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.
The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.
“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.
The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.
The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.
The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.
“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”
CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.
The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.
“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.
In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.
The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.
Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.
A version of this article first appeared on WebMD.com.
With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the Washington Post reported.
That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.
The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.
“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.
The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.
The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.
The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.
“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”
CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.
The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.
“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.
In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.
The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.
Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.
A version of this article first appeared on WebMD.com.
Strangulation deaths spur FDA alert on pediatric enteral feeding kits
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Universal hepatitis B screening, vaccination deemed cost effective for pregnant women
Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.
Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.
“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.
After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”
Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.
The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.
Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.
“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
Hepatitis B screening and vaccination for all pregnant women?
Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.
“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”
If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.
How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.
Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.
Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.
“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.
“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”
One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.
Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.
Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.
“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.
After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”
Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.
The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.
Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.
“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
Hepatitis B screening and vaccination for all pregnant women?
Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.
“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”
If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.
How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.
Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.
Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.
“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.
“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”
One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.
Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.
Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.
“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.
After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”
Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.
The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.
Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.
“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
Hepatitis B screening and vaccination for all pregnant women?
Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.
“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”
If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.
How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.
Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.
Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.
“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.
“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”
One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.
FROM OBSTETRICS & GYNECOLOGY
Dupilumab under FDA review for atopic dermatitis in children aged 6 months to 5 years
The
and Sanofi.If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.
Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.
The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.
Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.
The target action date for the FDA decision on this application is June 9, 2022.
The
and Sanofi.If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.
Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.
The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.
Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.
The target action date for the FDA decision on this application is June 9, 2022.
The
and Sanofi.If approved, dupilumab would be the first biologic approved for children in this age group in the United States, according to the statement. The proposed indication is as add-on therapy for children with moderate to severe AD not adequately controlled with topical prescription therapies or for whom topical therapies are not advised. The FDA granted breakthrough therapy designation for dupilumab for the treatment of severe AD in children aged 6 months to 11 years in 2016.
Approximately 85%-95% of atopic dermatitis patients develop symptoms before 5 years of age, and these symptoms often continue into adulthood, with an increased risk of skin infections and a significant impact on quality of life, according to the statement.
The sBLA is based on data from a phase 3 pivotal study of 162 children aged 6 months to 5 years in which dupilumab was added to standard-of-care topical corticosteroids, presented in December 2021. In the study, dupilumab plus standard of care significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with standard of care alone. Overall, 28% of the children randomized to dupilumab achieved the primary endpoint of clear or almost-clear skin, compared with 4% with those on standard of care alone (P < .0001), according to the manufacturers. Patients in the dupilumab group received either 200 mg (for children weighing ≥ 5 to < 15 kg) or 300 mg (for children weighing ≥ 15 to < 30 kg) every 4 weeks. Safety results were similar to those seen with dupilumab for children aged 6 years and older.
Conjunctivitis and herpes infections were among the most common adverse events associated with dupilumab in the study, according to the statement.
The target action date for the FDA decision on this application is June 9, 2022.
FROM THE FDA
E-cigarettes don’t help smokers quit, suggests new research
From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.
In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.
“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.
Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.
*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.
The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.
More research needed
The researchers acknowledged the need to review more recent data.
“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.
Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.
The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
Several findings surprised study author
Dr. Pierce said he was surprised by several aspects of the study findings.
“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.
“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.
The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.
“We don’t know about the high-nicotine versions,” he added.
New review advises against e-cigarettes for cessation
A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.
“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.
The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.
Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.
With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.
In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.
The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.
Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”
“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
Findings may guide patient conversations
The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.
“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.
Dr. Girgis also said she was not surprised by the findings.
“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.
“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.
With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.
Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.
“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”
“To continue to use e-cigarettes indefinitely should not be the goal,” she added.
The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.
The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.
*This article was updated on 2/28/2022.
From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.
In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.
“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.
Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.
*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.
The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.
More research needed
The researchers acknowledged the need to review more recent data.
“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.
Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.
The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
Several findings surprised study author
Dr. Pierce said he was surprised by several aspects of the study findings.
“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.
“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.
The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.
“We don’t know about the high-nicotine versions,” he added.
New review advises against e-cigarettes for cessation
A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.
“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.
The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.
Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.
With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.
In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.
The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.
Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”
“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
Findings may guide patient conversations
The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.
“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.
Dr. Girgis also said she was not surprised by the findings.
“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.
“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.
With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.
Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.
“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”
“To continue to use e-cigarettes indefinitely should not be the goal,” she added.
The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.
The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.
*This article was updated on 2/28/2022.
From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.
In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.
“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.
Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.
*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.
The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.
More research needed
The researchers acknowledged the need to review more recent data.
“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.
Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.
The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
Several findings surprised study author
Dr. Pierce said he was surprised by several aspects of the study findings.
“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.
“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.
The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.
“We don’t know about the high-nicotine versions,” he added.
New review advises against e-cigarettes for cessation
A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.
“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.
The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.
Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.
With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.
In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.
The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.
Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”
“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
Findings may guide patient conversations
The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.
“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.
Dr. Girgis also said she was not surprised by the findings.
“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.
“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.
With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.
Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.
“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”
“To continue to use e-cigarettes indefinitely should not be the goal,” she added.
The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.
The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.
*This article was updated on 2/28/2022.
FROM TOBACCO CONTROL
Scientists see hope in new therapy for COVID-19 brain fog patients
People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.
For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.
The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.
“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”
One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.
People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.
Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.
According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.
“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”
Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.
One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.
So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.
When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.
Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.
“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”
A version of this article first appeared on WebMD.com.
People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.
For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.
The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.
“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”
One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.
People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.
Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.
According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.
“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”
Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.
One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.
So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.
When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.
Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.
“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”
A version of this article first appeared on WebMD.com.
People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.
For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.
The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.
“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”
One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.
People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.
Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.
According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.
“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”
Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.
One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.
So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.
When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.
Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.
“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”
A version of this article first appeared on WebMD.com.
Growth in early life may predict early puberty
Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.
In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.
“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.
In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.
The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.
The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.
Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.
APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.
After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.
In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.
The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.
“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.
The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.
However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.
Time and timing limit practical application of results
The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”
The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.
“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.
“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”
The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.
In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.
“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.
In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.
The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.
The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.
Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.
APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.
After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.
In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.
The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.
“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.
The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.
However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.
Time and timing limit practical application of results
The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”
The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.
“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.
“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”
The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Faster gains in weight, length or height, or body mass index in the first 5 years of life were associated with an earlier onset of puberty in boys and girls, based on data from a cohort study of more than 7,000 children.
In recent decades, clinicians and parents have raised concerns about an earlier onset of puberty in children in the United States and other countries, Izzudin M. Aris, PhD, of Harvard Medical School, Boston, and colleagues wrote.
“Children with earlier pubertal onset not only may be at increased risk for long-term chronic diseases, but also may experience adverse consequences during adolescence, including psychosocial difficulties and dysmetabolism,” they said. However, the effect of growth in the first 5 years of life on pubertal onset has not been well studied.
In a study published in JAMA Network Open, the researchers identified 7,495 children from 36 cohorts participating in the Environmental Influences on Child Health Outcomes program from Jan. 1, 1986, to Dec. 31, 2015.
The study population included 3,772 girls and 3,723 boys; 60% reported as White, 23% as Black, 15% as Hispanic, 12% as one of the following: American Indian or Alaska Native, Native Hawaiian or Pacific Islander, multiple races, or other race. Most (84.1%) were born during or after the year 2000.
The primary outcome was the pubertal growth spurt, also known as age at peak height velocity (APHV). The researchers measured growth at 3 age periods in the first 5 years (early infancy, late infancy, and early childhood) and estimated rates of weight, length or height, and body mass index (BMI) gain. Secondary outcomes included self-reported pubic hair staging and scores on the Pubertal Development Scale.
Overall, weight and length or height gain velocities declined in the first 5 years of life, and boys had faster gains in early infancy, compared with girls.
APHV was negatively correlated with puberty scores and Tanner staging for pubic hair development in both boys and girls, while puberty score was positively correlated with Tanner staging for pubic hair in both sexes.
After controlling for maternal and child confounders including maternal age at delivery, maternal education level, and year of birth, faster gains in weight, length or height, or BMI at each of the three measurement periods in early life was associated with earlier APHV in boys. No effect was noted for race, maternal education level, or birth year.
In girls, faster gains in weight, length, or height, only at the latest measurement period (early childhood) were associated with younger APHV. No associations with APHV occurred for velocities of BMI gain at any age period in girls, the researchers noted. However, age at menarche was positively correlated with early APHV and negatively correlated with puberty score and Tanner staging for pubic hair.
The findings support previous studies of associations between child growth and pubertal onset, the researchers wrote. The mechanisms of action are many, and have not been explained, the researchers wrote in their discussion of the findings.
“We speculate that insulinlike growth factor 1 may be a factor in the associations observed in the present study, either directly or indirectly through sex steroid synthesis and secretion. Alternatively, in girls, androgens and adipokines may be factors in the observed associations for pubic hair staging and menarche, respectively,” they said. Genetics and other factors including social factors, environmental exposures, diet, and physical activity also affect growth in early life.
The study findings were limited by several factors including the use of child-reported measures of pubic hair staging and parent reports of pubertal scores, with the potential for error and misclassification, the researchers noted. Other limitations include a lack of data on maternal age at menarche and the use of weight-for-length rather than BMI for children younger than 2 years.
However, the results were strengthened by the large sample size, long-term follow-up, and especially the use of a nationally representative contemporary cohort that addresses gaps in the current literature from later time periods. The results support the associations of sex-specific early pubertal onset in children with faster growth early in life. “In the long term, results of the present study may inform future research that aims to develop and/or test preventive interventions to optimize nutrition, environmental exposures, physical activity, and other behaviors related to growth during these age periods,” they concluded.
Time and timing limit practical application of results
The current study addresses two issues that are ongoing concerns for clinicians, specifically, the rise in obesity in childhood and its potential link to an earlier age of entry into puberty, M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
“Authors in prior studies have suggested that earlier puberty, and indeed earlier menarche, in females may be associated with the potential of long-term health issues,” Dr. Jay noted. “It has also been suggested that both early maturing females and males may be impacted psychosocially. Others have suggested that the pathways through puberty are key and environmental factors as well as nutrition can have an impact on adolescence as well as health consequences later in life.”
The current study is important because it focused on children born in the present era of the obesity epidemic, while earlier studies were conducted on a group in the 1960s-1980s. “This study suggests that there are sex-specific associations of faster growth and earlier entry into puberty,” Dr. Jay said.
“While it is exciting to consider closer monitoring of pubertal progression in pediatric settings, often patients and families do not present in a timely manner for assessment,” she said. “Also, the authors suggest that preventive support may be offered to children who are traversing puberty at earlier ages. However, given the current stress on practices with COVID as well as stress on providers offering clinical services, identifying supportive interventions may be a stretch at best for practitioners already burdened by clinical and administrative demands.
“Ongoing studies are needed to address the knowledge gaps that exist in the arena of pubertal onset and growth during childhood across life periods,” said Dr. Jay. “In the long term, the present study may help direct research that could focus on preventive interventions to optimize nutrition, physical activity, environmental exposures, and other factors that intersect growth during infancy through early childhood, which may hasten early pubertal development’s later sequelae in adulthood.”
The study was supported by various grants to the researchers from the Environmental Influences on Child Health Outcomes program, Office of the Director, National Institutes of Health, as well as the Colorado Clinical and Translational Sciences Institute, University of Colorado at Denver. Lead author Dr. Aris had no financial conflicts to disclose. Dr. Jay had no conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM JAMA NETWORK OPEN
Docs react: NyQuil chicken and endless eye mucus
It’s the season of love. In that spirit,
Lean in and get a whiff of the latest good, bad, and ugly videos making the rounds on the internet’s most perplexing platform. But don’t get too close; these videos are especially ripe.The bad: NyQuil chicken
You know something bad has happened when your TikTok search ends with a warning from the app that says “Learn how to recognize harmful trends and hoaxes.” That’s what shows up now when you try to find out what the “NyQuil chicken” or “sleepy chicken” trend is (or was) all about.
TikTok videos, including this one from TikTok user @janelleandkate, show users trying out a trend meant to cook up a meal that will also cure your cold symptoms. The trend involves cooking chicken in a pan full of the cold and flu medicine NyQuil. The NyQuil chicken idea stems from a Twitter meme from 2017, so it is possible that some of the recent videos are fake (blue food coloring is easy to get, people).
However, in the instance that people believe the videos to be real and want to try the trend out, it is important to warn that this shouldn’t be attempted.
Aaron Hartman, MD, assistant clinical professor of family medicine at Virginia Commonwealth University, told the website Mic about the trend’s dangers: “When you cook cough medicine like NyQuil, however, you boil off the water and alcohol in it, leaving the chicken saturated with a super concentrated amount of drugs in the meat. If you ate one of those cutlets completely cooked, it’d be as if you’re actually consuming a quarter to half a bottle of NyQuil.”
And that’s not good for anyone. What ever happened to an old fashioned herb marinade?
The good: Can you fart yourself blind? Doc explains
It’s something we’ve all wondered about, right?
TikTok and YouTube’s mainstay plastic surgeon Anthony Youn, MD, took it upon himself to reply to a comment saying “I once farted so hard I went blind for 3 minutes.” This phenomenon, according to Dr. Youn, is very rare, but not impossible, though we wouldn’t exactly want to try it for ourselves.
In the humorous (but very informative!) video, Dr. Youn explains that particularly pungent flatulence can contain large amounts of hydrogen sulfide, a gas that is known for smelling like rotten eggs. According to the Occupational Safety and Health Administration, hydrogen sulfide is produced in a number of industries, like oil and gas refining, mining, and paper processing. Exposure to higher concentrations of hydrogen sulfide can be dangerous, with prolonged exposure at a 2-5 parts per million (ppm) concentration causing nausea, headaches, and airway problems in some asthma patients. At very high concentrations, it can be fatal.
Thankfully, a person’s gas is not at all that dangerous. When it comes to the commentor’s claim, Dr. Youn says that something else hydrogen sulfide can do is reduce blood pressure.
“If it reduces blood pressure to the central retinal artery,” Dr. Youn says, “your silent but deadly toot could theoretically make you go blind.”
Thank goodness we can lay that question to rest.
The ugly: Eye boogers from hell
Get a look at this!
This video from @mikaylaadiorr has amassed over 8 million likes and over 89,000 comments, and shows someone, who we can assume is Mikayla, pulling some sort of long string-like material out of the corner of her eye. It’s like a clown’s never-ending handkerchief, only goopy.
These mucus eye strings are caused by untreated eye conditions, like dry eye or pink eye (conjunctivitis), but pulling the mucus out is actually a symptom of what is called mucus fishing syndrome. As you know, our eyes are covered in layers of mucus and tears, which keeps our eyeballs lubricated and also protects us from bacteria and viruses. It’s possible to dry out the eyes by pulling some mucus off, but our eyes aren’t big fans of that, so they’ll create more mucus to keep from drying out.
A person who might get a bit addicted to pulling the strings out has likely developed mucus fishing syndrome, which is considered a body-focused repetitive behavior (BFRB); other BFRBs include skin-picking (dermatillomania) or picking hairs out (trichotillomania).
Popular TikToker and Oregon ophthalmologist Will Flanary, MD, aka Dr. Glaucomflecken, responded to the videos, which have been encouraging others to try it.
“This is called mucus fishing syndrome,” the ophthalmologist explained via text captions in his video. “The trauma from pulling mucus out of your eye causes more mucus to form. You get caught in a never-ending cycle that gets worse over time. So…stop it.”
Fingers off the mucus, people.
A version of this article first appeared on Medscape.com.
It’s the season of love. In that spirit,
Lean in and get a whiff of the latest good, bad, and ugly videos making the rounds on the internet’s most perplexing platform. But don’t get too close; these videos are especially ripe.The bad: NyQuil chicken
You know something bad has happened when your TikTok search ends with a warning from the app that says “Learn how to recognize harmful trends and hoaxes.” That’s what shows up now when you try to find out what the “NyQuil chicken” or “sleepy chicken” trend is (or was) all about.
TikTok videos, including this one from TikTok user @janelleandkate, show users trying out a trend meant to cook up a meal that will also cure your cold symptoms. The trend involves cooking chicken in a pan full of the cold and flu medicine NyQuil. The NyQuil chicken idea stems from a Twitter meme from 2017, so it is possible that some of the recent videos are fake (blue food coloring is easy to get, people).
However, in the instance that people believe the videos to be real and want to try the trend out, it is important to warn that this shouldn’t be attempted.
Aaron Hartman, MD, assistant clinical professor of family medicine at Virginia Commonwealth University, told the website Mic about the trend’s dangers: “When you cook cough medicine like NyQuil, however, you boil off the water and alcohol in it, leaving the chicken saturated with a super concentrated amount of drugs in the meat. If you ate one of those cutlets completely cooked, it’d be as if you’re actually consuming a quarter to half a bottle of NyQuil.”
And that’s not good for anyone. What ever happened to an old fashioned herb marinade?
The good: Can you fart yourself blind? Doc explains
It’s something we’ve all wondered about, right?
TikTok and YouTube’s mainstay plastic surgeon Anthony Youn, MD, took it upon himself to reply to a comment saying “I once farted so hard I went blind for 3 minutes.” This phenomenon, according to Dr. Youn, is very rare, but not impossible, though we wouldn’t exactly want to try it for ourselves.
In the humorous (but very informative!) video, Dr. Youn explains that particularly pungent flatulence can contain large amounts of hydrogen sulfide, a gas that is known for smelling like rotten eggs. According to the Occupational Safety and Health Administration, hydrogen sulfide is produced in a number of industries, like oil and gas refining, mining, and paper processing. Exposure to higher concentrations of hydrogen sulfide can be dangerous, with prolonged exposure at a 2-5 parts per million (ppm) concentration causing nausea, headaches, and airway problems in some asthma patients. At very high concentrations, it can be fatal.
Thankfully, a person’s gas is not at all that dangerous. When it comes to the commentor’s claim, Dr. Youn says that something else hydrogen sulfide can do is reduce blood pressure.
“If it reduces blood pressure to the central retinal artery,” Dr. Youn says, “your silent but deadly toot could theoretically make you go blind.”
Thank goodness we can lay that question to rest.
The ugly: Eye boogers from hell
Get a look at this!
This video from @mikaylaadiorr has amassed over 8 million likes and over 89,000 comments, and shows someone, who we can assume is Mikayla, pulling some sort of long string-like material out of the corner of her eye. It’s like a clown’s never-ending handkerchief, only goopy.
These mucus eye strings are caused by untreated eye conditions, like dry eye or pink eye (conjunctivitis), but pulling the mucus out is actually a symptom of what is called mucus fishing syndrome. As you know, our eyes are covered in layers of mucus and tears, which keeps our eyeballs lubricated and also protects us from bacteria and viruses. It’s possible to dry out the eyes by pulling some mucus off, but our eyes aren’t big fans of that, so they’ll create more mucus to keep from drying out.
A person who might get a bit addicted to pulling the strings out has likely developed mucus fishing syndrome, which is considered a body-focused repetitive behavior (BFRB); other BFRBs include skin-picking (dermatillomania) or picking hairs out (trichotillomania).
Popular TikToker and Oregon ophthalmologist Will Flanary, MD, aka Dr. Glaucomflecken, responded to the videos, which have been encouraging others to try it.
“This is called mucus fishing syndrome,” the ophthalmologist explained via text captions in his video. “The trauma from pulling mucus out of your eye causes more mucus to form. You get caught in a never-ending cycle that gets worse over time. So…stop it.”
Fingers off the mucus, people.
A version of this article first appeared on Medscape.com.
It’s the season of love. In that spirit,
Lean in and get a whiff of the latest good, bad, and ugly videos making the rounds on the internet’s most perplexing platform. But don’t get too close; these videos are especially ripe.The bad: NyQuil chicken
You know something bad has happened when your TikTok search ends with a warning from the app that says “Learn how to recognize harmful trends and hoaxes.” That’s what shows up now when you try to find out what the “NyQuil chicken” or “sleepy chicken” trend is (or was) all about.
TikTok videos, including this one from TikTok user @janelleandkate, show users trying out a trend meant to cook up a meal that will also cure your cold symptoms. The trend involves cooking chicken in a pan full of the cold and flu medicine NyQuil. The NyQuil chicken idea stems from a Twitter meme from 2017, so it is possible that some of the recent videos are fake (blue food coloring is easy to get, people).
However, in the instance that people believe the videos to be real and want to try the trend out, it is important to warn that this shouldn’t be attempted.
Aaron Hartman, MD, assistant clinical professor of family medicine at Virginia Commonwealth University, told the website Mic about the trend’s dangers: “When you cook cough medicine like NyQuil, however, you boil off the water and alcohol in it, leaving the chicken saturated with a super concentrated amount of drugs in the meat. If you ate one of those cutlets completely cooked, it’d be as if you’re actually consuming a quarter to half a bottle of NyQuil.”
And that’s not good for anyone. What ever happened to an old fashioned herb marinade?
The good: Can you fart yourself blind? Doc explains
It’s something we’ve all wondered about, right?
TikTok and YouTube’s mainstay plastic surgeon Anthony Youn, MD, took it upon himself to reply to a comment saying “I once farted so hard I went blind for 3 minutes.” This phenomenon, according to Dr. Youn, is very rare, but not impossible, though we wouldn’t exactly want to try it for ourselves.
In the humorous (but very informative!) video, Dr. Youn explains that particularly pungent flatulence can contain large amounts of hydrogen sulfide, a gas that is known for smelling like rotten eggs. According to the Occupational Safety and Health Administration, hydrogen sulfide is produced in a number of industries, like oil and gas refining, mining, and paper processing. Exposure to higher concentrations of hydrogen sulfide can be dangerous, with prolonged exposure at a 2-5 parts per million (ppm) concentration causing nausea, headaches, and airway problems in some asthma patients. At very high concentrations, it can be fatal.
Thankfully, a person’s gas is not at all that dangerous. When it comes to the commentor’s claim, Dr. Youn says that something else hydrogen sulfide can do is reduce blood pressure.
“If it reduces blood pressure to the central retinal artery,” Dr. Youn says, “your silent but deadly toot could theoretically make you go blind.”
Thank goodness we can lay that question to rest.
The ugly: Eye boogers from hell
Get a look at this!
This video from @mikaylaadiorr has amassed over 8 million likes and over 89,000 comments, and shows someone, who we can assume is Mikayla, pulling some sort of long string-like material out of the corner of her eye. It’s like a clown’s never-ending handkerchief, only goopy.
These mucus eye strings are caused by untreated eye conditions, like dry eye or pink eye (conjunctivitis), but pulling the mucus out is actually a symptom of what is called mucus fishing syndrome. As you know, our eyes are covered in layers of mucus and tears, which keeps our eyeballs lubricated and also protects us from bacteria and viruses. It’s possible to dry out the eyes by pulling some mucus off, but our eyes aren’t big fans of that, so they’ll create more mucus to keep from drying out.
A person who might get a bit addicted to pulling the strings out has likely developed mucus fishing syndrome, which is considered a body-focused repetitive behavior (BFRB); other BFRBs include skin-picking (dermatillomania) or picking hairs out (trichotillomania).
Popular TikToker and Oregon ophthalmologist Will Flanary, MD, aka Dr. Glaucomflecken, responded to the videos, which have been encouraging others to try it.
“This is called mucus fishing syndrome,” the ophthalmologist explained via text captions in his video. “The trauma from pulling mucus out of your eye causes more mucus to form. You get caught in a never-ending cycle that gets worse over time. So…stop it.”
Fingers off the mucus, people.
A version of this article first appeared on Medscape.com.