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Long COVID leads to greater health risks, research finds
That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.
“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”
The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.
“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”
Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.
“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”
People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.
A version of this article first appeared on WebMD.com.
That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.
“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”
The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.
“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”
Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.
“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”
People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.
A version of this article first appeared on WebMD.com.
That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.
“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”
The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.
“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”
Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.
“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”
People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE
Consider housing insecurity, other issues when managing challenging skin diseases in children, expert says
ASHEVILLE, N.C. – , according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.
As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.
“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.
“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.
To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.
“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.
Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.
“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.
Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.
While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.
Participatory action research
Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.
The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.
PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.
Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.
While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.
“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.
Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.
“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.
Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.
ASHEVILLE, N.C. – , according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.
As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.
“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.
“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.
To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.
“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.
Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.
“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.
Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.
While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.
Participatory action research
Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.
The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.
PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.
Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.
While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.
“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.
Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.
“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.
Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.
ASHEVILLE, N.C. – , according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.
As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.
“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.
“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.
To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.
“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.
Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.
“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.
Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.
While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.
Participatory action research
Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.
The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.
PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.
Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.
While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.
“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.
Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.
“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.
Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.
AT SPD 2023
New RSV shot is a monoclonal antibody, not a vaccine
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
Type 1 diabetes management improves as technology advances
Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.
The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.
The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.
“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.
On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.
Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.
This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
As overall use of technology use rose, A1c levels fell
The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.
Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).
But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).
Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).
The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”
The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
The more technology, the lower the A1c
Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.
Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).
The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
Work to be done: Why aren’t more achieving < 7% with AIDs?
Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:
First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.
Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.
Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”
He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”
Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”
Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.
A version of this article first appeared on Medscape.com.
Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.
The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.
The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.
“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.
On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.
Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.
This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
As overall use of technology use rose, A1c levels fell
The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.
Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).
But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).
Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).
The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”
The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
The more technology, the lower the A1c
Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.
Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).
The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
Work to be done: Why aren’t more achieving < 7% with AIDs?
Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:
First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.
Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.
Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”
He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”
Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”
Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.
A version of this article first appeared on Medscape.com.
Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.
The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.
The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.
“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.
On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.
Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.
This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
As overall use of technology use rose, A1c levels fell
The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.
Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).
But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).
Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).
The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”
The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
The more technology, the lower the A1c
Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.
Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).
The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
Work to be done: Why aren’t more achieving < 7% with AIDs?
Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:
First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.
Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.
Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”
He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”
Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”
Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.
A version of this article first appeared on Medscape.com.
FROM DIABETES CARE
Marijuana, hallucinogen use, binge drinking at all-time high
The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.
“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.
The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.
The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.
About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.
Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.
Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.
Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
Marijuana popular among younger Americans
“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.
Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.
Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.
Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.
NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”
A version of this article first appeared on Medscape.com.
The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.
“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.
The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.
The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.
About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.
Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.
Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.
Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
Marijuana popular among younger Americans
“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.
Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.
Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.
Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.
NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”
A version of this article first appeared on Medscape.com.
The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.
“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.
The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.
The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.
About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.
Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.
Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.
Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
Marijuana popular among younger Americans
“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.
Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.
Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.
Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.
NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”
A version of this article first appeared on Medscape.com.
Getting COVID shots in same arm may be more effective, study says
Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.
Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.
The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.
“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.
William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.
There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.
The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.
A version of this article first appeared on Medscape.com.
Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.
Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.
The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.
“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.
William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.
There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.
The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.
A version of this article first appeared on Medscape.com.
Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.
Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.
The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.
“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.
William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.
There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.
The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.
A version of this article first appeared on Medscape.com.
FROM EBIOMEDICINE
Parental bias about a doctor can’t trump a patient’s health
This transcript has been edited for clarity.
I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.
The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.
The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.
The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.
Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.
Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.
My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.
Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.
I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.
Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.
When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.
I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.
We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.
Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.
The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.
The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.
The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.
Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.
Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.
My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.
Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.
I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.
Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.
When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.
I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.
We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.
Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.
The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.
The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.
The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.
Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.
Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.
My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.
Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.
I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.
Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.
When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.
I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.
We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.
Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.
A version of this article first appeared on Medscape.com.
Delayed introduction of allergens increases allergy risk
These findings were published in Allergy.
Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.
The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.
Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.
These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
ELFE: The first cohort to follow children from birth to adulthood
ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.
This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.
These findings were published in Allergy.
Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.
The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.
Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.
These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
ELFE: The first cohort to follow children from birth to adulthood
ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.
This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.
These findings were published in Allergy.
Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.
The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.
Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.
These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
ELFE: The first cohort to follow children from birth to adulthood
ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.
This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.
FROM ALLERGY
FDA approves first RSV vaccine for pregnancy
The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.
Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.
However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.
Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.
RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.
This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.
In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.
Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.
The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.
A version of this article first appeared on Medscape.com.
The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.
Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.
However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.
Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.
RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.
This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.
In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.
Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.
The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.
A version of this article first appeared on Medscape.com.
The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.
Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.
However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.
Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.
RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.
This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.
In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.
Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.
The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.
A version of this article first appeared on Medscape.com.
Could a malpractice insurer drop you when you need it most?
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.