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New child COVID-19 cases drop for second consecutive week
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
School-based asthma program improves asthma care coordination for children
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
FROM AAAAI 2021
FDA set to okay Pfizer vaccine in younger teens
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
Doctors lose jobs after speaking out about unsafe conditions
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
A Pivotal Moment in Cancer Surgery, Captured on Film
Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.
Medscape Oncology © 2021 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.
Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.
Medscape Oncology © 2021 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.
Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.
Medscape Oncology © 2021 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.
AHA guidance on blood clots linked to COVID-19 vaccine
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
FDA moves to ban menthol in cigarettes
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
CDC guidelines coming on long COVID
The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.
In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.
“They should be coming out very shortly,” Dr. Brooks said.
The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.
For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.
National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.
“I can’t overstate how serious this issue is for the health of our nation,” he said.
Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.
“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.
Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.
“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”
Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.
“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
Patients testify
Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.
Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”
Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.
“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”
She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.
“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”
Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.
“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.
In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.
“They should be coming out very shortly,” Dr. Brooks said.
The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.
For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.
National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.
“I can’t overstate how serious this issue is for the health of our nation,” he said.
Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.
“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.
Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.
“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”
Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.
“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
Patients testify
Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.
Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”
Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.
“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”
She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.
“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”
Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.
“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.
In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.
“They should be coming out very shortly,” Dr. Brooks said.
The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.
For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.
National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.
“I can’t overstate how serious this issue is for the health of our nation,” he said.
Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.
“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.
Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.
“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”
Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.
“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
Patients testify
Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.
Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”
Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.
“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”
She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.
“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”
Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.
“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”
A version of this article first appeared on Medscape.com.
Being overweight ups risk of severe COVID-19 in hospital
In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.
“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.
The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.
This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.
Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.
“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.
“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
Study implications: Data show that overweight, obesity add to risk
These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.
“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.
Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.
“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”
“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.
“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
Does being overweight up risk of worse COVID-19 outcomes?
About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.
The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.
Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.
To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.
Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.
Just over half (60%) of the individuals were male, and 52% were older than 65.
Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
Increased need for respiratory support, same mortality risk
Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.
Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.
Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.
“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.
Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.
As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
A living meta-analysis, call for more collaborators
“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”
No specific project funded the study. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.
“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.
The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.
This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.
Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.
“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.
“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
Study implications: Data show that overweight, obesity add to risk
These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.
“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.
Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.
“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”
“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.
“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
Does being overweight up risk of worse COVID-19 outcomes?
About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.
The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.
Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.
To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.
Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.
Just over half (60%) of the individuals were male, and 52% were older than 65.
Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
Increased need for respiratory support, same mortality risk
Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.
Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.
Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.
“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.
Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.
As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
A living meta-analysis, call for more collaborators
“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”
No specific project funded the study. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.
“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.
The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.
This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.
Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.
“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.
“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
Study implications: Data show that overweight, obesity add to risk
These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.
“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.
Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.
“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”
“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.
“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
Does being overweight up risk of worse COVID-19 outcomes?
About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.
The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.
Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.
To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.
Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.
Just over half (60%) of the individuals were male, and 52% were older than 65.
Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
Increased need for respiratory support, same mortality risk
Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.
Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.
Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.
“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.
Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.
As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
A living meta-analysis, call for more collaborators
“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”
No specific project funded the study. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pfizer developing pill to treat COVID-19 symptoms
“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.
So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.
An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.
“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”
The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.
Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.
The company announced in late March that it was starting clinical trials on the oral drug.
In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.
A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.
A version of this article first appeared on WebMD.com.
“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.
So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.
An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.
“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”
The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.
Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.
The company announced in late March that it was starting clinical trials on the oral drug.
In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.
A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.
A version of this article first appeared on WebMD.com.
“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.
So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.
An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.
“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”
The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.
Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.
The company announced in late March that it was starting clinical trials on the oral drug.
In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.
A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.
A version of this article first appeared on WebMD.com.