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ID Practitioner is an independent news source that provides infectious disease specialists with timely and relevant news and commentary about clinical developments and the impact of health care policy on the infectious disease specialist’s practice. Specialty focus topics include antimicrobial resistance, emerging infections, global ID, hepatitis, HIV, hospital-acquired infections, immunizations and vaccines, influenza, mycoses, pediatric infections, and STIs. Infectious Diseases News is owned by Frontline Medical Communications.
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Autopsies show COVID virus invades entire body
A study on the subject was published in the journal Nature. The researchers completed autopsies from April 2020 to March 2021 of 44 unvaccinated people who had severe COVID-19. The median age was 62.5 years old, and 30% were female. Extensive brain sampling was done for 11 cases.
Because of its nature as a respiratory illness, SARS-CoV-2 was most widespread in the respiratory system such as in the lungs. But it was also found in 79 other body locations, including the heart, kidneys, liver, muscles, nerves, reproductive tract, and eyes.
The researchers said their work shows the SARS-CoV-2 “is capable of infecting and replicating within the human brain.” They also said their results indicate the virus spreads via the blood early during infection, which “seeds the virus throughout the body following infection of the respiratory tract.”
The authors noted that, while the virus was found outside the respiratory tract, they did not find signs of inflammation beyond the respiratory system.
The results will help narrow down treatments for long COVID, and particularly support the idea of using the antiviral drug Paxlovid to treat long COVID, according to a blog post from the National Institute of Allergy and Infectious Diseases. A clinical trial is already underway examining the treatment, and results are expected in January 2024.
A version of this article first appeared on WebMD.com.
A study on the subject was published in the journal Nature. The researchers completed autopsies from April 2020 to March 2021 of 44 unvaccinated people who had severe COVID-19. The median age was 62.5 years old, and 30% were female. Extensive brain sampling was done for 11 cases.
Because of its nature as a respiratory illness, SARS-CoV-2 was most widespread in the respiratory system such as in the lungs. But it was also found in 79 other body locations, including the heart, kidneys, liver, muscles, nerves, reproductive tract, and eyes.
The researchers said their work shows the SARS-CoV-2 “is capable of infecting and replicating within the human brain.” They also said their results indicate the virus spreads via the blood early during infection, which “seeds the virus throughout the body following infection of the respiratory tract.”
The authors noted that, while the virus was found outside the respiratory tract, they did not find signs of inflammation beyond the respiratory system.
The results will help narrow down treatments for long COVID, and particularly support the idea of using the antiviral drug Paxlovid to treat long COVID, according to a blog post from the National Institute of Allergy and Infectious Diseases. A clinical trial is already underway examining the treatment, and results are expected in January 2024.
A version of this article first appeared on WebMD.com.
A study on the subject was published in the journal Nature. The researchers completed autopsies from April 2020 to March 2021 of 44 unvaccinated people who had severe COVID-19. The median age was 62.5 years old, and 30% were female. Extensive brain sampling was done for 11 cases.
Because of its nature as a respiratory illness, SARS-CoV-2 was most widespread in the respiratory system such as in the lungs. But it was also found in 79 other body locations, including the heart, kidneys, liver, muscles, nerves, reproductive tract, and eyes.
The researchers said their work shows the SARS-CoV-2 “is capable of infecting and replicating within the human brain.” They also said their results indicate the virus spreads via the blood early during infection, which “seeds the virus throughout the body following infection of the respiratory tract.”
The authors noted that, while the virus was found outside the respiratory tract, they did not find signs of inflammation beyond the respiratory system.
The results will help narrow down treatments for long COVID, and particularly support the idea of using the antiviral drug Paxlovid to treat long COVID, according to a blog post from the National Institute of Allergy and Infectious Diseases. A clinical trial is already underway examining the treatment, and results are expected in January 2024.
A version of this article first appeared on WebMD.com.
FROM NATURE
New study offers details on post-COVID pediatric illness
Multisystem inflammatory syndrome in children (MIS-C) is more common than previously thought. This pediatric illness occurs 2-6 weeks after being infected with COVID-19.
study found. The illness is rare, but it causes dangerous multiorgan dysfunction and frequently requires a stay in the ICU. According to the Centers for Disease Control and Prevention, there have been at least 9,333 cases nationwide and 76 deaths from MIS-C.
Researchers said their findings were in such contrast to previous MIS-C research that it may render the old research “misleading.”
The analysis was powered by improved data extracted from hospital billing systems. Previous analyses of MIS-C were limited to voluntarily reported cases, which is likely the reason for the undercount.
The study reported a mortality rate for people with the most severe cases (affecting six to eight organs) of 5.8%. The authors of a companion editorial to the study said the mortality rate was low when considering the widespread impacts, “reflecting the rapid reversibility of MIS-C” with treatment.
Differences in MIS-C cases were also found based on children’s race and ethnicity. Black patients were more likely to have severe cases affecting more organs, compared to white patients.
The study included 4,107 MIS-C cases, using data from 2021 for patients younger than 21 years old. The median age was 9 years old.
The findings provide direction for further research, the editorial writers suggested.
Questions that need to be answered include asking why Black children with MIS-C are more likely to have a higher number of organ systems affected.
“Identifying patient biological or socioeconomic factors that can be targeted for treatment or prevention should be pursued,” they wrote.
The CDC says symptoms of MIS-C are an ongoing fever plus more than one of the following: stomach pain, bloodshot eyes, diarrhea, dizziness or lightheadedness (signs of low blood pressure), skin rash, or vomiting.
A version of this article first appeared on WebMD.com.
Multisystem inflammatory syndrome in children (MIS-C) is more common than previously thought. This pediatric illness occurs 2-6 weeks after being infected with COVID-19.
study found. The illness is rare, but it causes dangerous multiorgan dysfunction and frequently requires a stay in the ICU. According to the Centers for Disease Control and Prevention, there have been at least 9,333 cases nationwide and 76 deaths from MIS-C.
Researchers said their findings were in such contrast to previous MIS-C research that it may render the old research “misleading.”
The analysis was powered by improved data extracted from hospital billing systems. Previous analyses of MIS-C were limited to voluntarily reported cases, which is likely the reason for the undercount.
The study reported a mortality rate for people with the most severe cases (affecting six to eight organs) of 5.8%. The authors of a companion editorial to the study said the mortality rate was low when considering the widespread impacts, “reflecting the rapid reversibility of MIS-C” with treatment.
Differences in MIS-C cases were also found based on children’s race and ethnicity. Black patients were more likely to have severe cases affecting more organs, compared to white patients.
The study included 4,107 MIS-C cases, using data from 2021 for patients younger than 21 years old. The median age was 9 years old.
The findings provide direction for further research, the editorial writers suggested.
Questions that need to be answered include asking why Black children with MIS-C are more likely to have a higher number of organ systems affected.
“Identifying patient biological or socioeconomic factors that can be targeted for treatment or prevention should be pursued,” they wrote.
The CDC says symptoms of MIS-C are an ongoing fever plus more than one of the following: stomach pain, bloodshot eyes, diarrhea, dizziness or lightheadedness (signs of low blood pressure), skin rash, or vomiting.
A version of this article first appeared on WebMD.com.
Multisystem inflammatory syndrome in children (MIS-C) is more common than previously thought. This pediatric illness occurs 2-6 weeks after being infected with COVID-19.
study found. The illness is rare, but it causes dangerous multiorgan dysfunction and frequently requires a stay in the ICU. According to the Centers for Disease Control and Prevention, there have been at least 9,333 cases nationwide and 76 deaths from MIS-C.
Researchers said their findings were in such contrast to previous MIS-C research that it may render the old research “misleading.”
The analysis was powered by improved data extracted from hospital billing systems. Previous analyses of MIS-C were limited to voluntarily reported cases, which is likely the reason for the undercount.
The study reported a mortality rate for people with the most severe cases (affecting six to eight organs) of 5.8%. The authors of a companion editorial to the study said the mortality rate was low when considering the widespread impacts, “reflecting the rapid reversibility of MIS-C” with treatment.
Differences in MIS-C cases were also found based on children’s race and ethnicity. Black patients were more likely to have severe cases affecting more organs, compared to white patients.
The study included 4,107 MIS-C cases, using data from 2021 for patients younger than 21 years old. The median age was 9 years old.
The findings provide direction for further research, the editorial writers suggested.
Questions that need to be answered include asking why Black children with MIS-C are more likely to have a higher number of organ systems affected.
“Identifying patient biological or socioeconomic factors that can be targeted for treatment or prevention should be pursued,” they wrote.
The CDC says symptoms of MIS-C are an ongoing fever plus more than one of the following: stomach pain, bloodshot eyes, diarrhea, dizziness or lightheadedness (signs of low blood pressure), skin rash, or vomiting.
A version of this article first appeared on WebMD.com.
FROM JAMA NETWORK OPEN
Advanced Primary Care program boosts COVID-19 results
The better outcomes were seen in higher vaccination rates and fewer infections, hospitalizations, and deaths from the disease, according to study authors, led by Emily Gruber, MBA, MPH, with the Maryland Primary Care Program, Maryland Department of Health in Baltimore.
The results were published online in JAMA Network Open.
The study population was divided into MDPCP participants (n = 208,146) and a matched cohort (n = 37,203) of beneficiaries not attributed to MDPCP practices but who met eligibility criteria for study participation from Jan. 1, 2020, through Dec. 31, 2021.
More vaccinations, more antibody treatments
Researchers broke down the comparisons of better outcomes: 84.47% of MDPCP beneficiaries were fully vaccinated vs. 77.93% of nonparticipating beneficiaries (P less than .001). COVID-19–positive program beneficiaries also received monoclonal antibody treatment more often (8.45% vs. 6.11%; P less than .001).
Plus, program participants received more care via telehealth (62.95% vs. 54.53%; P less than .001) compared with those not participating.
Regarding secondary outcomes, MDPCP beneficiaries had lower rates of COVID cases (6.55% vs. 7.09%; P less than .001), lower rates of COVID-19 hospitalizations (1.81% vs. 2.06%; P = .001), and lower rates of death due to COVID-19 (0.56% vs. 0.77%; P less than .001).
Program components
Enrollment in the MDPCP is voluntary, and primary care practices can apply each year to be part of the program.
The model integrates primary care and public health in the pandemic response. It was created by the Maryland Department of Health (MDH) and the Centers for Medicare & Medicaid Services (CMS).
It expands the role of primary care to include services such as expanded care management, integrated behavioral health, data-driven care, and screenings and referrals to address social needs.
Coauthor Howard Haft, MD, MMM, with the Maryland Department of Public Health, said in an interview that among the most important factors in the program’s success were giving providers vaccines to distribute and then giving providers data on how many patients are vaccinated, and who’s not vaccinated but at high risk, and how those rates compare to other practices.
As to whether this could be a widespread model, Dr. Haft said, “It’s highly replicable.”
“Every state in the nation overall has all of these resources. It’s a matter of having the operational and political will to put those resources together. Almost every state has the technological ability to use their health information exchange to help tie pieces together.”
Vaccines and testing made available to providers
Making ample vaccines and testing available to providers in their offices helped patients get those services in a place they trust, Dr. Haft said.
The model also included a payment system for providers that included a significant amount of non–visit-based payments when many locations were closed in the height of the pandemic.
“That helped financially,” as did providing free telehealth platforms to practices with training on how to use them, Dr. Haft said.
‘Innovative and important’
Renu Tipirneni, MD, an assistant professor of internal medicine at the University of Michigan and at the Institute for Healthcare Policy and Innovation in Ann Arbor, said Maryland is out front putting into practice what practices nationwide aspire to do – coordinating physical and mental health and social needs and integrating primary and public health. Dr. Tipirneni, who was not involved with the study, said she was impressed the researchers were able to show statistically significant improvement with COVID-19 outcomes in the first 2 years.
“In terms of health outcomes, we often have to wait longer to see good outcomes,” she said. “It’s a really innovative and important model.”
She said states can learn from each other and this model is an example.
Integrating primary care and public health and addressing social needs may be the biggest challenges for states, she said, as those realms typically have been siloed.
“But they may be the key components to achieving these outcomes,” she said.
Take-home message
The most important benefit of the program is that data suggest it saves lives, according to Dr. Haft. While the actual difference between COVID deaths in the program and nonprogram groups was small, multiplying that savings across the nation shows substantial potential benefit, he explained.
“At a time when we were losing lives at an unconscionable rate, we were able to make a difference in saving lives,” Dr. Haft said.
Authors report no relevant financial disclosures.
The study received financial support from the Maryland Department of Health.
Dr. Tiperneni is helping evaluate Michigan’s Medicaid contract.
The better outcomes were seen in higher vaccination rates and fewer infections, hospitalizations, and deaths from the disease, according to study authors, led by Emily Gruber, MBA, MPH, with the Maryland Primary Care Program, Maryland Department of Health in Baltimore.
The results were published online in JAMA Network Open.
The study population was divided into MDPCP participants (n = 208,146) and a matched cohort (n = 37,203) of beneficiaries not attributed to MDPCP practices but who met eligibility criteria for study participation from Jan. 1, 2020, through Dec. 31, 2021.
More vaccinations, more antibody treatments
Researchers broke down the comparisons of better outcomes: 84.47% of MDPCP beneficiaries were fully vaccinated vs. 77.93% of nonparticipating beneficiaries (P less than .001). COVID-19–positive program beneficiaries also received monoclonal antibody treatment more often (8.45% vs. 6.11%; P less than .001).
Plus, program participants received more care via telehealth (62.95% vs. 54.53%; P less than .001) compared with those not participating.
Regarding secondary outcomes, MDPCP beneficiaries had lower rates of COVID cases (6.55% vs. 7.09%; P less than .001), lower rates of COVID-19 hospitalizations (1.81% vs. 2.06%; P = .001), and lower rates of death due to COVID-19 (0.56% vs. 0.77%; P less than .001).
Program components
Enrollment in the MDPCP is voluntary, and primary care practices can apply each year to be part of the program.
The model integrates primary care and public health in the pandemic response. It was created by the Maryland Department of Health (MDH) and the Centers for Medicare & Medicaid Services (CMS).
It expands the role of primary care to include services such as expanded care management, integrated behavioral health, data-driven care, and screenings and referrals to address social needs.
Coauthor Howard Haft, MD, MMM, with the Maryland Department of Public Health, said in an interview that among the most important factors in the program’s success were giving providers vaccines to distribute and then giving providers data on how many patients are vaccinated, and who’s not vaccinated but at high risk, and how those rates compare to other practices.
As to whether this could be a widespread model, Dr. Haft said, “It’s highly replicable.”
“Every state in the nation overall has all of these resources. It’s a matter of having the operational and political will to put those resources together. Almost every state has the technological ability to use their health information exchange to help tie pieces together.”
Vaccines and testing made available to providers
Making ample vaccines and testing available to providers in their offices helped patients get those services in a place they trust, Dr. Haft said.
The model also included a payment system for providers that included a significant amount of non–visit-based payments when many locations were closed in the height of the pandemic.
“That helped financially,” as did providing free telehealth platforms to practices with training on how to use them, Dr. Haft said.
‘Innovative and important’
Renu Tipirneni, MD, an assistant professor of internal medicine at the University of Michigan and at the Institute for Healthcare Policy and Innovation in Ann Arbor, said Maryland is out front putting into practice what practices nationwide aspire to do – coordinating physical and mental health and social needs and integrating primary and public health. Dr. Tipirneni, who was not involved with the study, said she was impressed the researchers were able to show statistically significant improvement with COVID-19 outcomes in the first 2 years.
“In terms of health outcomes, we often have to wait longer to see good outcomes,” she said. “It’s a really innovative and important model.”
She said states can learn from each other and this model is an example.
Integrating primary care and public health and addressing social needs may be the biggest challenges for states, she said, as those realms typically have been siloed.
“But they may be the key components to achieving these outcomes,” she said.
Take-home message
The most important benefit of the program is that data suggest it saves lives, according to Dr. Haft. While the actual difference between COVID deaths in the program and nonprogram groups was small, multiplying that savings across the nation shows substantial potential benefit, he explained.
“At a time when we were losing lives at an unconscionable rate, we were able to make a difference in saving lives,” Dr. Haft said.
Authors report no relevant financial disclosures.
The study received financial support from the Maryland Department of Health.
Dr. Tiperneni is helping evaluate Michigan’s Medicaid contract.
The better outcomes were seen in higher vaccination rates and fewer infections, hospitalizations, and deaths from the disease, according to study authors, led by Emily Gruber, MBA, MPH, with the Maryland Primary Care Program, Maryland Department of Health in Baltimore.
The results were published online in JAMA Network Open.
The study population was divided into MDPCP participants (n = 208,146) and a matched cohort (n = 37,203) of beneficiaries not attributed to MDPCP practices but who met eligibility criteria for study participation from Jan. 1, 2020, through Dec. 31, 2021.
More vaccinations, more antibody treatments
Researchers broke down the comparisons of better outcomes: 84.47% of MDPCP beneficiaries were fully vaccinated vs. 77.93% of nonparticipating beneficiaries (P less than .001). COVID-19–positive program beneficiaries also received monoclonal antibody treatment more often (8.45% vs. 6.11%; P less than .001).
Plus, program participants received more care via telehealth (62.95% vs. 54.53%; P less than .001) compared with those not participating.
Regarding secondary outcomes, MDPCP beneficiaries had lower rates of COVID cases (6.55% vs. 7.09%; P less than .001), lower rates of COVID-19 hospitalizations (1.81% vs. 2.06%; P = .001), and lower rates of death due to COVID-19 (0.56% vs. 0.77%; P less than .001).
Program components
Enrollment in the MDPCP is voluntary, and primary care practices can apply each year to be part of the program.
The model integrates primary care and public health in the pandemic response. It was created by the Maryland Department of Health (MDH) and the Centers for Medicare & Medicaid Services (CMS).
It expands the role of primary care to include services such as expanded care management, integrated behavioral health, data-driven care, and screenings and referrals to address social needs.
Coauthor Howard Haft, MD, MMM, with the Maryland Department of Public Health, said in an interview that among the most important factors in the program’s success were giving providers vaccines to distribute and then giving providers data on how many patients are vaccinated, and who’s not vaccinated but at high risk, and how those rates compare to other practices.
As to whether this could be a widespread model, Dr. Haft said, “It’s highly replicable.”
“Every state in the nation overall has all of these resources. It’s a matter of having the operational and political will to put those resources together. Almost every state has the technological ability to use their health information exchange to help tie pieces together.”
Vaccines and testing made available to providers
Making ample vaccines and testing available to providers in their offices helped patients get those services in a place they trust, Dr. Haft said.
The model also included a payment system for providers that included a significant amount of non–visit-based payments when many locations were closed in the height of the pandemic.
“That helped financially,” as did providing free telehealth platforms to practices with training on how to use them, Dr. Haft said.
‘Innovative and important’
Renu Tipirneni, MD, an assistant professor of internal medicine at the University of Michigan and at the Institute for Healthcare Policy and Innovation in Ann Arbor, said Maryland is out front putting into practice what practices nationwide aspire to do – coordinating physical and mental health and social needs and integrating primary and public health. Dr. Tipirneni, who was not involved with the study, said she was impressed the researchers were able to show statistically significant improvement with COVID-19 outcomes in the first 2 years.
“In terms of health outcomes, we often have to wait longer to see good outcomes,” she said. “It’s a really innovative and important model.”
She said states can learn from each other and this model is an example.
Integrating primary care and public health and addressing social needs may be the biggest challenges for states, she said, as those realms typically have been siloed.
“But they may be the key components to achieving these outcomes,” she said.
Take-home message
The most important benefit of the program is that data suggest it saves lives, according to Dr. Haft. While the actual difference between COVID deaths in the program and nonprogram groups was small, multiplying that savings across the nation shows substantial potential benefit, he explained.
“At a time when we were losing lives at an unconscionable rate, we were able to make a difference in saving lives,” Dr. Haft said.
Authors report no relevant financial disclosures.
The study received financial support from the Maryland Department of Health.
Dr. Tiperneni is helping evaluate Michigan’s Medicaid contract.
FROM JAMA NETWORK OPEN
Pediatric vaccination rates have failed to recover
I guess we shouldn’t be surprised that vaccination rates in this country fell during the frenzy created by the COVID pandemic. We had a lot on our plates. Schools closed and many of us retreated into what seemed to be the safety of our homes. Parents were reluctant to take their children anywhere, let alone a pediatrician’s office. State health agencies wisely focused on collecting case figures and then shepherding the efforts to immunize against SARS-CoV-2 once vaccines were available. Tracking and promoting the existing children’s vaccinations fell off the priority list, even in places with exemplary vaccination rates.
Whether or not the pandemic is over continues to be a topic for debate, but there is clearly a general shift toward a new normalcy. However, vaccination rates of our children have not rebounded to prepandemic levels. In fact, in some areas they are continuing to fall.
In a recent guest essay in the New York Times, Ezekiel J. Emmanuel, MD, PhD, a physician and professor of medical ethics and health policy at the University of Pennsylvania, and Matthew Guido, his research assistant, explore the reasons for this lack of a significant rebound. The authors cite recent outbreaks of measles in Ohio and polio in New York City as examples of the peril we are facing if we fail to reverse the trend. In some areas measles vaccine rates alarmingly have dipped below the threshold for herd immunity.
While Dr. Emmanuel and Mr. Guido acknowledge that the pandemic was a major driver of the falling vaccination rates they lay blame on the persistent decline on three factors that they view as correctable: nonmedical exemptions, our failure to vigorously enforce existing vaccine requirements, and inadequate public health campaigns.
The authors underestimate the lingering effect of the pandemic on parents’ vaccine hesitancy. As a septuagenarian who often hangs out with other septuagenarians I view the rapid development and effectiveness of the COVID vaccine as astounding and a boost for vaccines in general. However, were I much younger I might treat the vaccine’s success with a shrug. After some initial concern, the younger half of the population didn’t seem to see the illness as much of a threat to themselves or their peers. This attitude was reinforced by the fact that few of their peers, including those who were unvaccinated, were getting seriously ill. Despite all the hype, most parents and their children never ended up getting seriously ill.
You can understand why many parents might be quick to toss what you and I consider a successful COVID vaccine onto what they view as a growing pile of vaccines for diseases that in their experience have never sickened or killed anyone they have known.
Let’s be honest: Over the last half century we have produced several generations of parents who have little knowledge and certainly no personal experience with a childhood disease on the order or magnitude of polio. The vaccines that we have developed during their lifetimes have been targeted at diseases such as haemophilus influenzae meningitis that, while serious and anxiety provoking for pediatricians, occur so sporadically that most parents have no personal experience to motivate them to vaccinate their children.
Dr. Emmanuel and Mr. Guido are correct in advocating for the broader elimination of nonmedical exemptions and urging us to find the political will to vigorously enforce the vaccine requirements we have already enacted. I agree that our promotional campaigns need to be more robust. But, this will be a difficult challenge unless we can impress our audience with our straight talk and honesty. We must acknowledge and then explain why all vaccines are not created equal and that some are of more critical importance than others.
We are slowly learning that education isn’t the cure-all for vaccine hesitancy we once thought it was. And using scare tactics can backfire and create dysfunctional anxiety. We must choosing our words and target audience carefully. And ... having the political will to force parents into doing the right thing will be critical if we wish to restore our vaccination rates.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
I guess we shouldn’t be surprised that vaccination rates in this country fell during the frenzy created by the COVID pandemic. We had a lot on our plates. Schools closed and many of us retreated into what seemed to be the safety of our homes. Parents were reluctant to take their children anywhere, let alone a pediatrician’s office. State health agencies wisely focused on collecting case figures and then shepherding the efforts to immunize against SARS-CoV-2 once vaccines were available. Tracking and promoting the existing children’s vaccinations fell off the priority list, even in places with exemplary vaccination rates.
Whether or not the pandemic is over continues to be a topic for debate, but there is clearly a general shift toward a new normalcy. However, vaccination rates of our children have not rebounded to prepandemic levels. In fact, in some areas they are continuing to fall.
In a recent guest essay in the New York Times, Ezekiel J. Emmanuel, MD, PhD, a physician and professor of medical ethics and health policy at the University of Pennsylvania, and Matthew Guido, his research assistant, explore the reasons for this lack of a significant rebound. The authors cite recent outbreaks of measles in Ohio and polio in New York City as examples of the peril we are facing if we fail to reverse the trend. In some areas measles vaccine rates alarmingly have dipped below the threshold for herd immunity.
While Dr. Emmanuel and Mr. Guido acknowledge that the pandemic was a major driver of the falling vaccination rates they lay blame on the persistent decline on three factors that they view as correctable: nonmedical exemptions, our failure to vigorously enforce existing vaccine requirements, and inadequate public health campaigns.
The authors underestimate the lingering effect of the pandemic on parents’ vaccine hesitancy. As a septuagenarian who often hangs out with other septuagenarians I view the rapid development and effectiveness of the COVID vaccine as astounding and a boost for vaccines in general. However, were I much younger I might treat the vaccine’s success with a shrug. After some initial concern, the younger half of the population didn’t seem to see the illness as much of a threat to themselves or their peers. This attitude was reinforced by the fact that few of their peers, including those who were unvaccinated, were getting seriously ill. Despite all the hype, most parents and their children never ended up getting seriously ill.
You can understand why many parents might be quick to toss what you and I consider a successful COVID vaccine onto what they view as a growing pile of vaccines for diseases that in their experience have never sickened or killed anyone they have known.
Let’s be honest: Over the last half century we have produced several generations of parents who have little knowledge and certainly no personal experience with a childhood disease on the order or magnitude of polio. The vaccines that we have developed during their lifetimes have been targeted at diseases such as haemophilus influenzae meningitis that, while serious and anxiety provoking for pediatricians, occur so sporadically that most parents have no personal experience to motivate them to vaccinate their children.
Dr. Emmanuel and Mr. Guido are correct in advocating for the broader elimination of nonmedical exemptions and urging us to find the political will to vigorously enforce the vaccine requirements we have already enacted. I agree that our promotional campaigns need to be more robust. But, this will be a difficult challenge unless we can impress our audience with our straight talk and honesty. We must acknowledge and then explain why all vaccines are not created equal and that some are of more critical importance than others.
We are slowly learning that education isn’t the cure-all for vaccine hesitancy we once thought it was. And using scare tactics can backfire and create dysfunctional anxiety. We must choosing our words and target audience carefully. And ... having the political will to force parents into doing the right thing will be critical if we wish to restore our vaccination rates.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
I guess we shouldn’t be surprised that vaccination rates in this country fell during the frenzy created by the COVID pandemic. We had a lot on our plates. Schools closed and many of us retreated into what seemed to be the safety of our homes. Parents were reluctant to take their children anywhere, let alone a pediatrician’s office. State health agencies wisely focused on collecting case figures and then shepherding the efforts to immunize against SARS-CoV-2 once vaccines were available. Tracking and promoting the existing children’s vaccinations fell off the priority list, even in places with exemplary vaccination rates.
Whether or not the pandemic is over continues to be a topic for debate, but there is clearly a general shift toward a new normalcy. However, vaccination rates of our children have not rebounded to prepandemic levels. In fact, in some areas they are continuing to fall.
In a recent guest essay in the New York Times, Ezekiel J. Emmanuel, MD, PhD, a physician and professor of medical ethics and health policy at the University of Pennsylvania, and Matthew Guido, his research assistant, explore the reasons for this lack of a significant rebound. The authors cite recent outbreaks of measles in Ohio and polio in New York City as examples of the peril we are facing if we fail to reverse the trend. In some areas measles vaccine rates alarmingly have dipped below the threshold for herd immunity.
While Dr. Emmanuel and Mr. Guido acknowledge that the pandemic was a major driver of the falling vaccination rates they lay blame on the persistent decline on three factors that they view as correctable: nonmedical exemptions, our failure to vigorously enforce existing vaccine requirements, and inadequate public health campaigns.
The authors underestimate the lingering effect of the pandemic on parents’ vaccine hesitancy. As a septuagenarian who often hangs out with other septuagenarians I view the rapid development and effectiveness of the COVID vaccine as astounding and a boost for vaccines in general. However, were I much younger I might treat the vaccine’s success with a shrug. After some initial concern, the younger half of the population didn’t seem to see the illness as much of a threat to themselves or their peers. This attitude was reinforced by the fact that few of their peers, including those who were unvaccinated, were getting seriously ill. Despite all the hype, most parents and their children never ended up getting seriously ill.
You can understand why many parents might be quick to toss what you and I consider a successful COVID vaccine onto what they view as a growing pile of vaccines for diseases that in their experience have never sickened or killed anyone they have known.
Let’s be honest: Over the last half century we have produced several generations of parents who have little knowledge and certainly no personal experience with a childhood disease on the order or magnitude of polio. The vaccines that we have developed during their lifetimes have been targeted at diseases such as haemophilus influenzae meningitis that, while serious and anxiety provoking for pediatricians, occur so sporadically that most parents have no personal experience to motivate them to vaccinate their children.
Dr. Emmanuel and Mr. Guido are correct in advocating for the broader elimination of nonmedical exemptions and urging us to find the political will to vigorously enforce the vaccine requirements we have already enacted. I agree that our promotional campaigns need to be more robust. But, this will be a difficult challenge unless we can impress our audience with our straight talk and honesty. We must acknowledge and then explain why all vaccines are not created equal and that some are of more critical importance than others.
We are slowly learning that education isn’t the cure-all for vaccine hesitancy we once thought it was. And using scare tactics can backfire and create dysfunctional anxiety. We must choosing our words and target audience carefully. And ... having the political will to force parents into doing the right thing will be critical if we wish to restore our vaccination rates.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
ED doctors call private equity staffing practices illegal and seek to ban them
Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.
These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.
Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.
Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.
Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.
“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
‘Possibility to reverberate throughout the country’
The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”
The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.
But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.
The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”
The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.
“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.
Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”
TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
State rules vary widely
State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.
Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.
Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.
Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.
Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.
Other estimates put private equity’s penetration of ERs at closer to 40%.
Doctors push for investigations
So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.
An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.
The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.
Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.
Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.
A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
Differing views on private equity’s role
Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”
But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.
Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.
For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.
“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”
Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”
Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.
These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.
Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.
Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.
Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.
“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
‘Possibility to reverberate throughout the country’
The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”
The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.
But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.
The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”
The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.
“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.
Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”
TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
State rules vary widely
State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.
Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.
Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.
Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.
Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.
Other estimates put private equity’s penetration of ERs at closer to 40%.
Doctors push for investigations
So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.
An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.
The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.
Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.
Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.
A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
Differing views on private equity’s role
Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”
But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.
Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.
For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.
“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”
Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”
Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.
These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.
Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.
Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.
Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.
“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
‘Possibility to reverberate throughout the country’
The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”
The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.
But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.
The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”
The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.
“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.
Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”
TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
State rules vary widely
State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.
Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.
Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.
Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.
Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.
Other estimates put private equity’s penetration of ERs at closer to 40%.
Doctors push for investigations
So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.
An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.
The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.
Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.
Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.
A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
Differing views on private equity’s role
Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”
But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.
Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.
For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.
“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”
Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”
Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Long COVID clinical trials may offer shortcut to new treatments
With no proven treatments for long COVID, millions of Americans struggling with debilitating symptoms may be wondering whether it’s worth it to try something they’ve never considered before: a clinical trial.
“We’re not in warp speed,” said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute in Durham, N.C., who is overseeing long COVID trials for the NIH. Operation Warp Speed – the 2020-2021 federal effort to get COVID vaccines designed, tested, authorized and distributed – benefited from existing scientific knowledge about other coronaviruses and about vaccines in general. But there’s no similar foundation of scientific knowledge about long COVID.
“We are in a place of not really knowing anything,” Dr. Zimmerman said.
But some glimmers of hope are emerging. A Veterans Affairs study recently found the antiviral Paxlovid might help prevent long COVID. A small case study at Yale found the ADHD drug guanfacine may ease brain fog from long COVID. And preliminary results from an NIH-funded study suggest COVID vaccines might help children with a rare but serious inflammatory condition known as multisystem inflammatory syndrome (MIS-C).
More results are expected very soon from the trial for kids with MIS-C, which can strike suddenly long after a COVID infection clears up. While the exact causes aren’t yet clear, MIS-C can cause dangerous inflammation in the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal system.
Because the virus often triggered a delayed response of MIS-C in kids who had few if any symptoms of acute COVID-19, scientists wondered whether children infected with the virus might respond to a vaccine dose to prevent MIS-C from developing, Gary Gibbons, MD, director of the National Heart, Lung, and Blood Institute, said during a Dec. 9 presentation at the NIH. It’s not yet clear if vaccination helps, but it doesn’t harm the children, Dr. Gibbons said.
“Indeed, the studies suggest with some relief that yes, these children could be vaccinated safely,” he said.
Several new trials are also testing Paxlovid against long COVID, including one late-stage study that may have results in about a year.
“We already know that Paxlovid reduces the risk of developing long COVID, but it would be a game changer if it can improve long COVID symptoms as well,” said Surendra Barshikar, MD, an associate professor and medical director of the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.
In other studies, researchers are looking at a wide variety of previously approved and experimental drugs and devices. For example, scientists in New York are testing the mood stabilizer lithium to treat brain fog and fatigue. And researchers in Illinois are investigating efgartigimod, a drug approved for the rare muscle-weakening autoimmune disorder myasthenia gravis, to see if it helps ease a long COVID complication known as POTS that can cause a sudden rapid heart rate and chronic fatigue.
“The good news is that enrollment will proceed quickly, given the vast number of patients,” said Kristin Englund, MD, director of the reCOVer Center of Excellence at the Cleveland Clinic.
This is all encouraging because roughly one in five American adults who have acute COVID infections develop persistent symptoms of long COVID, also known as post–acute sequelae of SARS-CoV-2 (PASC). And many of these long COVID patients have complex, overlapping clusters of symptoms that make traditional treatment approaches largely ineffective against this new, formidable disease.
But not every patient living with long COVID will qualify for trials or find it easy to take part even if they do. Patients should consider how severe their symptoms are, the potential risks of any experimental treatments, and the many challenges they may have with getting to and from clinical trial sites that are largely concentrated around major cities and might be far from home.
While this holds true for any type of trial, it’s essential for long COVID patients, who may have fatigue, muscle weakness, and other symptoms that make distance an impossible factor to ignore, said Aaron Friedberg, MD, clinical colead of the post–COVID-19 recovery program at the Ohio State University Wexner Medical Center, Columbus.
“I think it is a personal decision, since the fatigue and pain that patients with PASC can experience can make it very challenging to travel long distances,” Dr. Friedberg said. “I would recommend calling or messaging ahead to find out exactly what type of travel might be required because there may be steps that can be completed by email or video, which could make it easier to participate, and some trials may be entirely remote.”
Even when patients feel up to the travel, they still might not be a good fit for a clinical trial. Scientists often look for people who didn’t have pre-existing health problems before they got long COVID, Dr. Barshikar noted. Patients taking medications may also be unable to participate in drug trials, particularly for experimental treatments because of concerns about unknown side effects from drug interactions.
When clinical trials do seem like a good option, patients may want to consider seeking treatment at an academic medical center that is already doing long COVID research, particularly if their symptoms are too complex or severe to manage only through their primary care provider, said Jonathan Whiteson, MD, who helped draft long COVID treatment guidelines for the American Academy of Physical Medicine and Rehabilitation. He also serves as codirector of the New York University Langone Health post–COVID care program.
Many health care professionals on the front lines treating long COVID patients are optimistic that the sheer number of trials and the vast number of patients taking part should ultimately produce some better treatment options than people have right now. It’s just not going to happen overnight.
“I suspect that while we will see some new treatments coming in the next 1-2 years, it may be several years before targets can be identified and full trials conducted to see results,” Dr. Friedberg said. “Getting good data takes time.”
A version of this article first appeared on WebMD.com.
With no proven treatments for long COVID, millions of Americans struggling with debilitating symptoms may be wondering whether it’s worth it to try something they’ve never considered before: a clinical trial.
“We’re not in warp speed,” said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute in Durham, N.C., who is overseeing long COVID trials for the NIH. Operation Warp Speed – the 2020-2021 federal effort to get COVID vaccines designed, tested, authorized and distributed – benefited from existing scientific knowledge about other coronaviruses and about vaccines in general. But there’s no similar foundation of scientific knowledge about long COVID.
“We are in a place of not really knowing anything,” Dr. Zimmerman said.
But some glimmers of hope are emerging. A Veterans Affairs study recently found the antiviral Paxlovid might help prevent long COVID. A small case study at Yale found the ADHD drug guanfacine may ease brain fog from long COVID. And preliminary results from an NIH-funded study suggest COVID vaccines might help children with a rare but serious inflammatory condition known as multisystem inflammatory syndrome (MIS-C).
More results are expected very soon from the trial for kids with MIS-C, which can strike suddenly long after a COVID infection clears up. While the exact causes aren’t yet clear, MIS-C can cause dangerous inflammation in the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal system.
Because the virus often triggered a delayed response of MIS-C in kids who had few if any symptoms of acute COVID-19, scientists wondered whether children infected with the virus might respond to a vaccine dose to prevent MIS-C from developing, Gary Gibbons, MD, director of the National Heart, Lung, and Blood Institute, said during a Dec. 9 presentation at the NIH. It’s not yet clear if vaccination helps, but it doesn’t harm the children, Dr. Gibbons said.
“Indeed, the studies suggest with some relief that yes, these children could be vaccinated safely,” he said.
Several new trials are also testing Paxlovid against long COVID, including one late-stage study that may have results in about a year.
“We already know that Paxlovid reduces the risk of developing long COVID, but it would be a game changer if it can improve long COVID symptoms as well,” said Surendra Barshikar, MD, an associate professor and medical director of the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.
In other studies, researchers are looking at a wide variety of previously approved and experimental drugs and devices. For example, scientists in New York are testing the mood stabilizer lithium to treat brain fog and fatigue. And researchers in Illinois are investigating efgartigimod, a drug approved for the rare muscle-weakening autoimmune disorder myasthenia gravis, to see if it helps ease a long COVID complication known as POTS that can cause a sudden rapid heart rate and chronic fatigue.
“The good news is that enrollment will proceed quickly, given the vast number of patients,” said Kristin Englund, MD, director of the reCOVer Center of Excellence at the Cleveland Clinic.
This is all encouraging because roughly one in five American adults who have acute COVID infections develop persistent symptoms of long COVID, also known as post–acute sequelae of SARS-CoV-2 (PASC). And many of these long COVID patients have complex, overlapping clusters of symptoms that make traditional treatment approaches largely ineffective against this new, formidable disease.
But not every patient living with long COVID will qualify for trials or find it easy to take part even if they do. Patients should consider how severe their symptoms are, the potential risks of any experimental treatments, and the many challenges they may have with getting to and from clinical trial sites that are largely concentrated around major cities and might be far from home.
While this holds true for any type of trial, it’s essential for long COVID patients, who may have fatigue, muscle weakness, and other symptoms that make distance an impossible factor to ignore, said Aaron Friedberg, MD, clinical colead of the post–COVID-19 recovery program at the Ohio State University Wexner Medical Center, Columbus.
“I think it is a personal decision, since the fatigue and pain that patients with PASC can experience can make it very challenging to travel long distances,” Dr. Friedberg said. “I would recommend calling or messaging ahead to find out exactly what type of travel might be required because there may be steps that can be completed by email or video, which could make it easier to participate, and some trials may be entirely remote.”
Even when patients feel up to the travel, they still might not be a good fit for a clinical trial. Scientists often look for people who didn’t have pre-existing health problems before they got long COVID, Dr. Barshikar noted. Patients taking medications may also be unable to participate in drug trials, particularly for experimental treatments because of concerns about unknown side effects from drug interactions.
When clinical trials do seem like a good option, patients may want to consider seeking treatment at an academic medical center that is already doing long COVID research, particularly if their symptoms are too complex or severe to manage only through their primary care provider, said Jonathan Whiteson, MD, who helped draft long COVID treatment guidelines for the American Academy of Physical Medicine and Rehabilitation. He also serves as codirector of the New York University Langone Health post–COVID care program.
Many health care professionals on the front lines treating long COVID patients are optimistic that the sheer number of trials and the vast number of patients taking part should ultimately produce some better treatment options than people have right now. It’s just not going to happen overnight.
“I suspect that while we will see some new treatments coming in the next 1-2 years, it may be several years before targets can be identified and full trials conducted to see results,” Dr. Friedberg said. “Getting good data takes time.”
A version of this article first appeared on WebMD.com.
With no proven treatments for long COVID, millions of Americans struggling with debilitating symptoms may be wondering whether it’s worth it to try something they’ve never considered before: a clinical trial.
“We’re not in warp speed,” said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute in Durham, N.C., who is overseeing long COVID trials for the NIH. Operation Warp Speed – the 2020-2021 federal effort to get COVID vaccines designed, tested, authorized and distributed – benefited from existing scientific knowledge about other coronaviruses and about vaccines in general. But there’s no similar foundation of scientific knowledge about long COVID.
“We are in a place of not really knowing anything,” Dr. Zimmerman said.
But some glimmers of hope are emerging. A Veterans Affairs study recently found the antiviral Paxlovid might help prevent long COVID. A small case study at Yale found the ADHD drug guanfacine may ease brain fog from long COVID. And preliminary results from an NIH-funded study suggest COVID vaccines might help children with a rare but serious inflammatory condition known as multisystem inflammatory syndrome (MIS-C).
More results are expected very soon from the trial for kids with MIS-C, which can strike suddenly long after a COVID infection clears up. While the exact causes aren’t yet clear, MIS-C can cause dangerous inflammation in the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal system.
Because the virus often triggered a delayed response of MIS-C in kids who had few if any symptoms of acute COVID-19, scientists wondered whether children infected with the virus might respond to a vaccine dose to prevent MIS-C from developing, Gary Gibbons, MD, director of the National Heart, Lung, and Blood Institute, said during a Dec. 9 presentation at the NIH. It’s not yet clear if vaccination helps, but it doesn’t harm the children, Dr. Gibbons said.
“Indeed, the studies suggest with some relief that yes, these children could be vaccinated safely,” he said.
Several new trials are also testing Paxlovid against long COVID, including one late-stage study that may have results in about a year.
“We already know that Paxlovid reduces the risk of developing long COVID, but it would be a game changer if it can improve long COVID symptoms as well,” said Surendra Barshikar, MD, an associate professor and medical director of the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.
In other studies, researchers are looking at a wide variety of previously approved and experimental drugs and devices. For example, scientists in New York are testing the mood stabilizer lithium to treat brain fog and fatigue. And researchers in Illinois are investigating efgartigimod, a drug approved for the rare muscle-weakening autoimmune disorder myasthenia gravis, to see if it helps ease a long COVID complication known as POTS that can cause a sudden rapid heart rate and chronic fatigue.
“The good news is that enrollment will proceed quickly, given the vast number of patients,” said Kristin Englund, MD, director of the reCOVer Center of Excellence at the Cleveland Clinic.
This is all encouraging because roughly one in five American adults who have acute COVID infections develop persistent symptoms of long COVID, also known as post–acute sequelae of SARS-CoV-2 (PASC). And many of these long COVID patients have complex, overlapping clusters of symptoms that make traditional treatment approaches largely ineffective against this new, formidable disease.
But not every patient living with long COVID will qualify for trials or find it easy to take part even if they do. Patients should consider how severe their symptoms are, the potential risks of any experimental treatments, and the many challenges they may have with getting to and from clinical trial sites that are largely concentrated around major cities and might be far from home.
While this holds true for any type of trial, it’s essential for long COVID patients, who may have fatigue, muscle weakness, and other symptoms that make distance an impossible factor to ignore, said Aaron Friedberg, MD, clinical colead of the post–COVID-19 recovery program at the Ohio State University Wexner Medical Center, Columbus.
“I think it is a personal decision, since the fatigue and pain that patients with PASC can experience can make it very challenging to travel long distances,” Dr. Friedberg said. “I would recommend calling or messaging ahead to find out exactly what type of travel might be required because there may be steps that can be completed by email or video, which could make it easier to participate, and some trials may be entirely remote.”
Even when patients feel up to the travel, they still might not be a good fit for a clinical trial. Scientists often look for people who didn’t have pre-existing health problems before they got long COVID, Dr. Barshikar noted. Patients taking medications may also be unable to participate in drug trials, particularly for experimental treatments because of concerns about unknown side effects from drug interactions.
When clinical trials do seem like a good option, patients may want to consider seeking treatment at an academic medical center that is already doing long COVID research, particularly if their symptoms are too complex or severe to manage only through their primary care provider, said Jonathan Whiteson, MD, who helped draft long COVID treatment guidelines for the American Academy of Physical Medicine and Rehabilitation. He also serves as codirector of the New York University Langone Health post–COVID care program.
Many health care professionals on the front lines treating long COVID patients are optimistic that the sheer number of trials and the vast number of patients taking part should ultimately produce some better treatment options than people have right now. It’s just not going to happen overnight.
“I suspect that while we will see some new treatments coming in the next 1-2 years, it may be several years before targets can be identified and full trials conducted to see results,” Dr. Friedberg said. “Getting good data takes time.”
A version of this article first appeared on WebMD.com.
What’s next for COVID? Here’s what to know
As holiday celebrations wind down in the United States, COVID is on the rise.
Cases, hospitalizations, deaths
As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before.
Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.
“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”
As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast.
Predicting a winter surge
Experts tracking the pandemic agree there will be a surge.
“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”
One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said.
Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.
“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said.
People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
Others point out that the surge doesn’t involve just COVID.
“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus).
Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.
Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.)
“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.”
Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”
“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”
What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”
Minimizing the damage
Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now.
“The same with the influenza vaccine,” Dr. Schaffner said.
Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”
The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.
Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC.
Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.
In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.
Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines.
Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said.
Back to mandates?
On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.
On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.
While the CDC order requiring masks on public transportation is no longer in effect, the agency continues to recommend that those using public transportation do so.
But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.
Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.
That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions.
“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”
There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
Glimmers of hope
Despite uncertainties, experts offered some not-so-dismal perspectives as well.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
A version of this article first appeared on WebMD.com.
As holiday celebrations wind down in the United States, COVID is on the rise.
Cases, hospitalizations, deaths
As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before.
Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.
“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”
As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast.
Predicting a winter surge
Experts tracking the pandemic agree there will be a surge.
“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”
One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said.
Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.
“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said.
People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
Others point out that the surge doesn’t involve just COVID.
“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus).
Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.
Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.)
“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.”
Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”
“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”
What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”
Minimizing the damage
Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now.
“The same with the influenza vaccine,” Dr. Schaffner said.
Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”
The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.
Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC.
Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.
In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.
Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines.
Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said.
Back to mandates?
On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.
On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.
While the CDC order requiring masks on public transportation is no longer in effect, the agency continues to recommend that those using public transportation do so.
But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.
Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.
That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions.
“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”
There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
Glimmers of hope
Despite uncertainties, experts offered some not-so-dismal perspectives as well.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
A version of this article first appeared on WebMD.com.
As holiday celebrations wind down in the United States, COVID is on the rise.
Cases, hospitalizations, deaths
As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before.
Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.
“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”
As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast.
Predicting a winter surge
Experts tracking the pandemic agree there will be a surge.
“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”
One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said.
Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.
“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said.
People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
Others point out that the surge doesn’t involve just COVID.
“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus).
Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.
Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.)
“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.”
Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”
“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”
What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”
Minimizing the damage
Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now.
“The same with the influenza vaccine,” Dr. Schaffner said.
Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”
The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.
Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC.
Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.
In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.
Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines.
Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said.
Back to mandates?
On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.
On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.
While the CDC order requiring masks on public transportation is no longer in effect, the agency continues to recommend that those using public transportation do so.
But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.
Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.
That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions.
“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”
There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
Glimmers of hope
Despite uncertainties, experts offered some not-so-dismal perspectives as well.
“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.
A version of this article first appeared on WebMD.com.
Medical practice gave 8,000 patients cancer for Christmas
We wish you a merry Christmas and a happy heart failure
Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.
Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.
It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.
One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
Genes know it: You are when you eat
There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.
The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.
The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.
Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
This group practice reduced stress for everyone
It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.
Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”
By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.
After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.
Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”
Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”
Who needs to make up stuff? Not us.
We wish you a merry Christmas and a happy heart failure
Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.
Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.
It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.
One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
Genes know it: You are when you eat
There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.
The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.
The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.
Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
This group practice reduced stress for everyone
It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.
Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”
By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.
After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.
Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”
Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”
Who needs to make up stuff? Not us.
We wish you a merry Christmas and a happy heart failure
Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.
Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.
It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.
One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
Genes know it: You are when you eat
There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.
The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.
The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.
Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
This group practice reduced stress for everyone
It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.
Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”
By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.
After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.
Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”
Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”
Who needs to make up stuff? Not us.
IBD patients have limited protection against Omicron with third vaccine dose
For people with inflammatory bowel disease (IBD) taking immunosuppressive medication, a third dose of a COVID-19 mRNA vaccine significantly increases neutralizing antibodies against the original SARS-CoV-2 strain, but the picture is more complicated for protection against the Omicron variant, according to a research letter published in Gastroenterology.
“As further mutations in the viral genome accumulate over time, with the attendant risk of immune evasion, it remains important to continue to reappraise vaccination strategy, including the implementation of personalized approaches for some patients, such as those treated with anti-TNF drugs and JAK inhibitors,” wrote Zhigang Liu, PhD, a research associate in the department of metabolism, digestion, and reproduction at Imperial College London, and his colleagues. “Preferential use of bivalent vaccines may be especially valuable in IBD patients taking anti-TNF agents or JAK inhibitors,” they wrote. Their study did not assess neutralizing antibodies resulting from use of the bivalent vaccine, however.
The researchers tracked 268 participants, including 49 healthy participants serving as controls, from May 2021 through March 2022. The other participants had IBD and included 51 patients taking thiopurines, 36 patients taking infliximab, 39 taking both infliximab and thiopurines, 39 taking ustekinumab, 38 taking vedolizumab, and 16 taking tofacitinib. The IBD patients were all enrolled in the SARS-CoV-2 Vaccination Immunogenicity in Immunosuppressed Inflammatory Bowel Disease Patients (VIP) cohort.
None of the participants had evidence of a SARS-CoV-2 infection at baseline. All had received two doses of an mRNA COVID-19 vaccine (all received Pfizer, except two controls who received Moderna) or two doses of the AstraZeneca vaccine as their primary vaccination. All received an mRNA vaccine for their third dose. Among the IBD patients, 137 received the AstraZeneca in their primary two-dose series, and 82 received Pfizer.
First the researchers assessed the participants’ humoral response to the vaccine against the original SARS-CoV-2 strain and against the Omicron BA.1 variant. Neutralizing antibody titers rose significantly against both strains after the third vaccine dose for all participants.
“However, 50% neutralization titer (NT50) values were significantly lower against Omicron than against the ancestral strain in all study groups, irrespective of the immunosuppressive treatment regimen,” the authors reported. NT50 values are a measure that reflect a vaccine-induced humoral immunity against SARS-CoV-2 after vaccination.
Compared to the healthy controls, individuals receiving infliximab, tofacitinib, or infliximab/thiopurine combination therapy showed significantly lower responses after the second and third vaccine doses. Thirteen patients did not generate NT50 against Omicron after the second vaccine dose, and 7 of them were on infliximab monotherapy. They represented nearly 20% of all infliximab monotherapy participants.
Next the researchers assessed the risk of a breakthrough infection according to neutralizing titer thresholds. Individuals with an NT50 less than 500 had 1.6 times greater odds of a breakthrough infection than those with an NT50 above 500, they noted. After two vaccine doses, 46% of participants with IBD had an NT50 above 500 for the ancestral strain, which rose to 85% of those with IBD after a third dose.
In the healthy control group, 35% had an NT50 under 500 after two doses, and 14% of them had a breakthrough infection, all of which were mild and none of which required hospitalization. The NT50 in healthy controls, however, was not significantly associated with risk of breakthrough infection.
“In this study, neutralizing titers elicited against the omicron variant were generally poor for all individuals and were substantially lower in recipients of infliximab, infliximab/thiopurine combination, or tofacitinib therapy,” the authors concluded. “This raises concerns about whether currently available vaccines will be sufficient to protect against continually evolving SARS-CoV-2 variants, especially in patients established on certain immunosuppressive drugs.”
The small population sizes for each subgroup based on medication was one of the study’s limitations. Another was the fact that it was underpowered to conclusively determine whether an increased risk of breakthrough infection exists in IBD patients who have lower titers of neutralizing antibodies. A limitation for generalization to U.S. patients is that just 64% of the IBD patients received the AstraZeneca vaccine, which is not offered in the United States, for their first two doses before receiving the third mRNA (Pfizer) dose.
The study was funded by Pfizer in an independent research grant and by the NIHR Biomedical Research Centres in Imperial College London and Imperial College Healthcare NHS Trust and Cambridge, and the NIHR Clinical Research Facility Cambridge.
Dr. Liu and one other author had no disclosures. The other 18 authors have a range of disclosures related to various pharmaceutical companies, including Pfizer.
Understanding how inflammatory bowel disease (IBD) impacts COVID-19 infection risk and how IBD medications influence this risk remains an ever-evolving discussion, particularly with the emergence of new SARS-CoV-2 variants and booster vaccines. In this study, Liu et al. further shape this conversation: They show that a third mRNA COVID-19 vaccine dose increases neutralizing antibody levels against the Omicron variant in IBD patients compared to the level following a second vaccine dose, but that infliximab and tofacitinib significantly attenuate this response. They additionally suggest that IBD patients achieve lower neutralizing antibody levels after a third COVID-19 vaccine and may have a higher breakthrough infection risk compared to healthy controls without IBD.
Whether to change booster vaccination recommendations specifically for IBD patients on tofacitinib or infliximab, however, remains an unanswered question. The small sample of patients on tofacitinib precludes definitive conclusions regarding tofacitinib’s impact on vaccine response. Moreover, this humoral antibody-based study tells only half the story: We need analyses of the cell-mediated booster vaccine response to truly understand vaccine efficacy during immunosuppressant use. Lastly, future studies including the bivalent booster will provide the most up-to-date information on protecting our IBD patients from the Omicron variant.
Dr. Erica J. Brenner MD, MSCR is an Assistant Professor, Department of Pediatrics, Division of Pediatric Gastroenterology, University of North Carolina School of Medicine; and a cofounder of the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) Registry. She has no relevant financial conflicts of interest.
Understanding how inflammatory bowel disease (IBD) impacts COVID-19 infection risk and how IBD medications influence this risk remains an ever-evolving discussion, particularly with the emergence of new SARS-CoV-2 variants and booster vaccines. In this study, Liu et al. further shape this conversation: They show that a third mRNA COVID-19 vaccine dose increases neutralizing antibody levels against the Omicron variant in IBD patients compared to the level following a second vaccine dose, but that infliximab and tofacitinib significantly attenuate this response. They additionally suggest that IBD patients achieve lower neutralizing antibody levels after a third COVID-19 vaccine and may have a higher breakthrough infection risk compared to healthy controls without IBD.
Whether to change booster vaccination recommendations specifically for IBD patients on tofacitinib or infliximab, however, remains an unanswered question. The small sample of patients on tofacitinib precludes definitive conclusions regarding tofacitinib’s impact on vaccine response. Moreover, this humoral antibody-based study tells only half the story: We need analyses of the cell-mediated booster vaccine response to truly understand vaccine efficacy during immunosuppressant use. Lastly, future studies including the bivalent booster will provide the most up-to-date information on protecting our IBD patients from the Omicron variant.
Dr. Erica J. Brenner MD, MSCR is an Assistant Professor, Department of Pediatrics, Division of Pediatric Gastroenterology, University of North Carolina School of Medicine; and a cofounder of the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) Registry. She has no relevant financial conflicts of interest.
Understanding how inflammatory bowel disease (IBD) impacts COVID-19 infection risk and how IBD medications influence this risk remains an ever-evolving discussion, particularly with the emergence of new SARS-CoV-2 variants and booster vaccines. In this study, Liu et al. further shape this conversation: They show that a third mRNA COVID-19 vaccine dose increases neutralizing antibody levels against the Omicron variant in IBD patients compared to the level following a second vaccine dose, but that infliximab and tofacitinib significantly attenuate this response. They additionally suggest that IBD patients achieve lower neutralizing antibody levels after a third COVID-19 vaccine and may have a higher breakthrough infection risk compared to healthy controls without IBD.
Whether to change booster vaccination recommendations specifically for IBD patients on tofacitinib or infliximab, however, remains an unanswered question. The small sample of patients on tofacitinib precludes definitive conclusions regarding tofacitinib’s impact on vaccine response. Moreover, this humoral antibody-based study tells only half the story: We need analyses of the cell-mediated booster vaccine response to truly understand vaccine efficacy during immunosuppressant use. Lastly, future studies including the bivalent booster will provide the most up-to-date information on protecting our IBD patients from the Omicron variant.
Dr. Erica J. Brenner MD, MSCR is an Assistant Professor, Department of Pediatrics, Division of Pediatric Gastroenterology, University of North Carolina School of Medicine; and a cofounder of the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) Registry. She has no relevant financial conflicts of interest.
For people with inflammatory bowel disease (IBD) taking immunosuppressive medication, a third dose of a COVID-19 mRNA vaccine significantly increases neutralizing antibodies against the original SARS-CoV-2 strain, but the picture is more complicated for protection against the Omicron variant, according to a research letter published in Gastroenterology.
“As further mutations in the viral genome accumulate over time, with the attendant risk of immune evasion, it remains important to continue to reappraise vaccination strategy, including the implementation of personalized approaches for some patients, such as those treated with anti-TNF drugs and JAK inhibitors,” wrote Zhigang Liu, PhD, a research associate in the department of metabolism, digestion, and reproduction at Imperial College London, and his colleagues. “Preferential use of bivalent vaccines may be especially valuable in IBD patients taking anti-TNF agents or JAK inhibitors,” they wrote. Their study did not assess neutralizing antibodies resulting from use of the bivalent vaccine, however.
The researchers tracked 268 participants, including 49 healthy participants serving as controls, from May 2021 through March 2022. The other participants had IBD and included 51 patients taking thiopurines, 36 patients taking infliximab, 39 taking both infliximab and thiopurines, 39 taking ustekinumab, 38 taking vedolizumab, and 16 taking tofacitinib. The IBD patients were all enrolled in the SARS-CoV-2 Vaccination Immunogenicity in Immunosuppressed Inflammatory Bowel Disease Patients (VIP) cohort.
None of the participants had evidence of a SARS-CoV-2 infection at baseline. All had received two doses of an mRNA COVID-19 vaccine (all received Pfizer, except two controls who received Moderna) or two doses of the AstraZeneca vaccine as their primary vaccination. All received an mRNA vaccine for their third dose. Among the IBD patients, 137 received the AstraZeneca in their primary two-dose series, and 82 received Pfizer.
First the researchers assessed the participants’ humoral response to the vaccine against the original SARS-CoV-2 strain and against the Omicron BA.1 variant. Neutralizing antibody titers rose significantly against both strains after the third vaccine dose for all participants.
“However, 50% neutralization titer (NT50) values were significantly lower against Omicron than against the ancestral strain in all study groups, irrespective of the immunosuppressive treatment regimen,” the authors reported. NT50 values are a measure that reflect a vaccine-induced humoral immunity against SARS-CoV-2 after vaccination.
Compared to the healthy controls, individuals receiving infliximab, tofacitinib, or infliximab/thiopurine combination therapy showed significantly lower responses after the second and third vaccine doses. Thirteen patients did not generate NT50 against Omicron after the second vaccine dose, and 7 of them were on infliximab monotherapy. They represented nearly 20% of all infliximab monotherapy participants.
Next the researchers assessed the risk of a breakthrough infection according to neutralizing titer thresholds. Individuals with an NT50 less than 500 had 1.6 times greater odds of a breakthrough infection than those with an NT50 above 500, they noted. After two vaccine doses, 46% of participants with IBD had an NT50 above 500 for the ancestral strain, which rose to 85% of those with IBD after a third dose.
In the healthy control group, 35% had an NT50 under 500 after two doses, and 14% of them had a breakthrough infection, all of which were mild and none of which required hospitalization. The NT50 in healthy controls, however, was not significantly associated with risk of breakthrough infection.
“In this study, neutralizing titers elicited against the omicron variant were generally poor for all individuals and were substantially lower in recipients of infliximab, infliximab/thiopurine combination, or tofacitinib therapy,” the authors concluded. “This raises concerns about whether currently available vaccines will be sufficient to protect against continually evolving SARS-CoV-2 variants, especially in patients established on certain immunosuppressive drugs.”
The small population sizes for each subgroup based on medication was one of the study’s limitations. Another was the fact that it was underpowered to conclusively determine whether an increased risk of breakthrough infection exists in IBD patients who have lower titers of neutralizing antibodies. A limitation for generalization to U.S. patients is that just 64% of the IBD patients received the AstraZeneca vaccine, which is not offered in the United States, for their first two doses before receiving the third mRNA (Pfizer) dose.
The study was funded by Pfizer in an independent research grant and by the NIHR Biomedical Research Centres in Imperial College London and Imperial College Healthcare NHS Trust and Cambridge, and the NIHR Clinical Research Facility Cambridge.
Dr. Liu and one other author had no disclosures. The other 18 authors have a range of disclosures related to various pharmaceutical companies, including Pfizer.
For people with inflammatory bowel disease (IBD) taking immunosuppressive medication, a third dose of a COVID-19 mRNA vaccine significantly increases neutralizing antibodies against the original SARS-CoV-2 strain, but the picture is more complicated for protection against the Omicron variant, according to a research letter published in Gastroenterology.
“As further mutations in the viral genome accumulate over time, with the attendant risk of immune evasion, it remains important to continue to reappraise vaccination strategy, including the implementation of personalized approaches for some patients, such as those treated with anti-TNF drugs and JAK inhibitors,” wrote Zhigang Liu, PhD, a research associate in the department of metabolism, digestion, and reproduction at Imperial College London, and his colleagues. “Preferential use of bivalent vaccines may be especially valuable in IBD patients taking anti-TNF agents or JAK inhibitors,” they wrote. Their study did not assess neutralizing antibodies resulting from use of the bivalent vaccine, however.
The researchers tracked 268 participants, including 49 healthy participants serving as controls, from May 2021 through March 2022. The other participants had IBD and included 51 patients taking thiopurines, 36 patients taking infliximab, 39 taking both infliximab and thiopurines, 39 taking ustekinumab, 38 taking vedolizumab, and 16 taking tofacitinib. The IBD patients were all enrolled in the SARS-CoV-2 Vaccination Immunogenicity in Immunosuppressed Inflammatory Bowel Disease Patients (VIP) cohort.
None of the participants had evidence of a SARS-CoV-2 infection at baseline. All had received two doses of an mRNA COVID-19 vaccine (all received Pfizer, except two controls who received Moderna) or two doses of the AstraZeneca vaccine as their primary vaccination. All received an mRNA vaccine for their third dose. Among the IBD patients, 137 received the AstraZeneca in their primary two-dose series, and 82 received Pfizer.
First the researchers assessed the participants’ humoral response to the vaccine against the original SARS-CoV-2 strain and against the Omicron BA.1 variant. Neutralizing antibody titers rose significantly against both strains after the third vaccine dose for all participants.
“However, 50% neutralization titer (NT50) values were significantly lower against Omicron than against the ancestral strain in all study groups, irrespective of the immunosuppressive treatment regimen,” the authors reported. NT50 values are a measure that reflect a vaccine-induced humoral immunity against SARS-CoV-2 after vaccination.
Compared to the healthy controls, individuals receiving infliximab, tofacitinib, or infliximab/thiopurine combination therapy showed significantly lower responses after the second and third vaccine doses. Thirteen patients did not generate NT50 against Omicron after the second vaccine dose, and 7 of them were on infliximab monotherapy. They represented nearly 20% of all infliximab monotherapy participants.
Next the researchers assessed the risk of a breakthrough infection according to neutralizing titer thresholds. Individuals with an NT50 less than 500 had 1.6 times greater odds of a breakthrough infection than those with an NT50 above 500, they noted. After two vaccine doses, 46% of participants with IBD had an NT50 above 500 for the ancestral strain, which rose to 85% of those with IBD after a third dose.
In the healthy control group, 35% had an NT50 under 500 after two doses, and 14% of them had a breakthrough infection, all of which were mild and none of which required hospitalization. The NT50 in healthy controls, however, was not significantly associated with risk of breakthrough infection.
“In this study, neutralizing titers elicited against the omicron variant were generally poor for all individuals and were substantially lower in recipients of infliximab, infliximab/thiopurine combination, or tofacitinib therapy,” the authors concluded. “This raises concerns about whether currently available vaccines will be sufficient to protect against continually evolving SARS-CoV-2 variants, especially in patients established on certain immunosuppressive drugs.”
The small population sizes for each subgroup based on medication was one of the study’s limitations. Another was the fact that it was underpowered to conclusively determine whether an increased risk of breakthrough infection exists in IBD patients who have lower titers of neutralizing antibodies. A limitation for generalization to U.S. patients is that just 64% of the IBD patients received the AstraZeneca vaccine, which is not offered in the United States, for their first two doses before receiving the third mRNA (Pfizer) dose.
The study was funded by Pfizer in an independent research grant and by the NIHR Biomedical Research Centres in Imperial College London and Imperial College Healthcare NHS Trust and Cambridge, and the NIHR Clinical Research Facility Cambridge.
Dr. Liu and one other author had no disclosures. The other 18 authors have a range of disclosures related to various pharmaceutical companies, including Pfizer.
FROM GASTROENTEROLOGY
SARS-CoV-2 seroprevalence grew rapidly in pandemic’s early waves
By August 2022, two-and-a-half years into the COVID-19 pandemic, most children as well as most adults under age 60 years had evidence of SARS-CoV-2 vaccination and/or infection, a Canadian seroprevalence study of almost 14,000 people over the first seven waves of the pandemic reports.
However, fewer than 50% people older than age 60, the age group most vulnerable to severe outcomes, showed evidence of immunity from infection or vaccination. The authors noted that older adults – who have the lowest infection rates but highest risk of severe outcomes – continue to warrant prioritized vaccination, writing online in the Canadian Medical Association Journal.
Previous evidence suggests that a combination of both infection and vaccination exposure may induce more robust and durable hybrid immunity than either exposure alone, according to lead author Danuta M. Skowronski, MD, MHSc, an epidemiologist at the British Columbia Centre for Disease Control in Vancouver.
“Our main objective was to chronicle the changing proportion of the population considered immunologically naive and therefore susceptible to SARS-CoV-2,” Dr. Skowronski said in an interview. “It’s relevant for risk assessment to know what proportion have acquired some priming for more efficient immune memory response to the virus because that reduces the likelihood of severe outcomes.” Standardized seroprevalence studies are essential to inform COVID-19 response, particularly in resource-limited regions.
The study
Conducted in British Columbia’s Greater Vancouver and Fraser Valley, the analysis found that in the first year of the pandemic, when extraordinary measures were in place to curtail transmission, virtually everyone remained immunologically naive. Thereafter, however, age-based vaccine rollouts dramatically changed the immuno-epidemiological landscape so that by September 2021, more than 80% of the study population had antibody evidence of immunological priming, while more than 85% remained uninfected.
By August 2022, after the Omicron-variant waves, overall vaccine- and infection-induced seroprevalence exceeded 95%, with 60% having been actually infected, including at least three-quarters of children. Fewer than 50% of older adults, however, showed immunological evidence of exposure.
The study results were based on anonymized residual sera from children and adults in an outpatient laboratory network. At least three immunoassays per serosurvey were used to detect antibodies to SARS-CoV-2 spike (from vaccine) and to nucleocapsid antibodies (from infection).
The researchers assessed any seroprevalence – vaccine-, infection-induced, or both – as defined by positivity on any two assays. Infection-induced seroprevalence was also defined by dual-assay positivity but required both antinucleocapsid and antispike detection. Their estimates of infection-induced seroprevalence indicated considerable under-ascertainment of infections by standard surveillance case reports.
Results
During the first year of the pandemic, fewer than 1% manifested seroprevalence during the first three snapshots and fewer than 5% by January 2021. With vaccine rollout, however, seroprevalence increased dramatically during the first half of 2021 to 56% by May/June 2021 and to 83% by September/October 2021.
In addition, infection-induced seroprevalence was low at less than 15% in September/October 2021 until the arrival of the Omicron waves, after which it rose to 42% by March 2022 and 61% by July/August 2022. Combined seroprevalence for vaccination or infection was more than 95% by the summer, with most children but less than half of adults older than 60 years showing evidence of having been infected.
“We found the highest infection rates among children, closely followed by young adults, which may reflect their greater interconnectedness, including between siblings and parents in the household, as well as with peers in schools and the community,” the authors wrote, adding that the low cumulative infection rates among older adults may reflect their higher vaccination rates and greater social isolation.
U.S. data show similar age-related infection rates, but data among children from other Canadian provinces are limited, the authors said.
Commenting on the survey but not involved in it, infectious diseases expert Marc Germain, MD, PhD, a vice president at Héma-Québec in Quebec City, believes the pattern observed in British Columbia is fairly representative of what happened across Canada and the United States, including the sweeping effect of the Omicron variant and the differential impact according to age.
“But regional differences might very well exist – for example, due to differential vaccine uptake – and are also probably related in part to the different testing platforms being used,” Dr. Germain told this news organization.
Caroline Quach-Tanh, MD, PhD, a pediatrician and epidemiologist/infectologist at the University of Montreal, pointed out that Quebec seroprevalence surveys using residual blood samples from children and adults visiting emergency departments for any reason showed higher rates of prior infection than did the BC surveys. “But Dr. Skowronski’s findings are likely applicable to settings where some nonpharmacological interventions were put in place, but without strict confinement – and thus are likely applicable to most settings in the U.S. and Canada.”
Dr. Quach-Tanh added that there is always a risk of bias with the use of residual blood samples, “but the fact that the study method was stable should have captured a similar population from time to time. It would be unlikely to result in a major overestimation in the proportion of individuals positive for SARS-CoV-2 antibodies.”
A recent global meta-analysis found that while global seroprevalence has risen considerably, albeit variably by region, more than a third of the world’s population is still seronegative to the SARS-CoV-2 virus.
Dr. Skowronski reported institutional grants from the Canadian Institutes of Health Research and the British Columbia Centre for Disease Control Foundation for Public Health for other SARSCoV-2 work. Coauthor Romina C. Reyes, MD, chairs the BC Diagnostic Accreditation Program committee. Coauthor Mel Krajden, MD, reported institutional grants from Roche, Hologic, and Siemens. Dr. Germain and Dr. Quach-Tanh disclosed no competing interests relevant to their comments.
By August 2022, two-and-a-half years into the COVID-19 pandemic, most children as well as most adults under age 60 years had evidence of SARS-CoV-2 vaccination and/or infection, a Canadian seroprevalence study of almost 14,000 people over the first seven waves of the pandemic reports.
However, fewer than 50% people older than age 60, the age group most vulnerable to severe outcomes, showed evidence of immunity from infection or vaccination. The authors noted that older adults – who have the lowest infection rates but highest risk of severe outcomes – continue to warrant prioritized vaccination, writing online in the Canadian Medical Association Journal.
Previous evidence suggests that a combination of both infection and vaccination exposure may induce more robust and durable hybrid immunity than either exposure alone, according to lead author Danuta M. Skowronski, MD, MHSc, an epidemiologist at the British Columbia Centre for Disease Control in Vancouver.
“Our main objective was to chronicle the changing proportion of the population considered immunologically naive and therefore susceptible to SARS-CoV-2,” Dr. Skowronski said in an interview. “It’s relevant for risk assessment to know what proportion have acquired some priming for more efficient immune memory response to the virus because that reduces the likelihood of severe outcomes.” Standardized seroprevalence studies are essential to inform COVID-19 response, particularly in resource-limited regions.
The study
Conducted in British Columbia’s Greater Vancouver and Fraser Valley, the analysis found that in the first year of the pandemic, when extraordinary measures were in place to curtail transmission, virtually everyone remained immunologically naive. Thereafter, however, age-based vaccine rollouts dramatically changed the immuno-epidemiological landscape so that by September 2021, more than 80% of the study population had antibody evidence of immunological priming, while more than 85% remained uninfected.
By August 2022, after the Omicron-variant waves, overall vaccine- and infection-induced seroprevalence exceeded 95%, with 60% having been actually infected, including at least three-quarters of children. Fewer than 50% of older adults, however, showed immunological evidence of exposure.
The study results were based on anonymized residual sera from children and adults in an outpatient laboratory network. At least three immunoassays per serosurvey were used to detect antibodies to SARS-CoV-2 spike (from vaccine) and to nucleocapsid antibodies (from infection).
The researchers assessed any seroprevalence – vaccine-, infection-induced, or both – as defined by positivity on any two assays. Infection-induced seroprevalence was also defined by dual-assay positivity but required both antinucleocapsid and antispike detection. Their estimates of infection-induced seroprevalence indicated considerable under-ascertainment of infections by standard surveillance case reports.
Results
During the first year of the pandemic, fewer than 1% manifested seroprevalence during the first three snapshots and fewer than 5% by January 2021. With vaccine rollout, however, seroprevalence increased dramatically during the first half of 2021 to 56% by May/June 2021 and to 83% by September/October 2021.
In addition, infection-induced seroprevalence was low at less than 15% in September/October 2021 until the arrival of the Omicron waves, after which it rose to 42% by March 2022 and 61% by July/August 2022. Combined seroprevalence for vaccination or infection was more than 95% by the summer, with most children but less than half of adults older than 60 years showing evidence of having been infected.
“We found the highest infection rates among children, closely followed by young adults, which may reflect their greater interconnectedness, including between siblings and parents in the household, as well as with peers in schools and the community,” the authors wrote, adding that the low cumulative infection rates among older adults may reflect their higher vaccination rates and greater social isolation.
U.S. data show similar age-related infection rates, but data among children from other Canadian provinces are limited, the authors said.
Commenting on the survey but not involved in it, infectious diseases expert Marc Germain, MD, PhD, a vice president at Héma-Québec in Quebec City, believes the pattern observed in British Columbia is fairly representative of what happened across Canada and the United States, including the sweeping effect of the Omicron variant and the differential impact according to age.
“But regional differences might very well exist – for example, due to differential vaccine uptake – and are also probably related in part to the different testing platforms being used,” Dr. Germain told this news organization.
Caroline Quach-Tanh, MD, PhD, a pediatrician and epidemiologist/infectologist at the University of Montreal, pointed out that Quebec seroprevalence surveys using residual blood samples from children and adults visiting emergency departments for any reason showed higher rates of prior infection than did the BC surveys. “But Dr. Skowronski’s findings are likely applicable to settings where some nonpharmacological interventions were put in place, but without strict confinement – and thus are likely applicable to most settings in the U.S. and Canada.”
Dr. Quach-Tanh added that there is always a risk of bias with the use of residual blood samples, “but the fact that the study method was stable should have captured a similar population from time to time. It would be unlikely to result in a major overestimation in the proportion of individuals positive for SARS-CoV-2 antibodies.”
A recent global meta-analysis found that while global seroprevalence has risen considerably, albeit variably by region, more than a third of the world’s population is still seronegative to the SARS-CoV-2 virus.
Dr. Skowronski reported institutional grants from the Canadian Institutes of Health Research and the British Columbia Centre for Disease Control Foundation for Public Health for other SARSCoV-2 work. Coauthor Romina C. Reyes, MD, chairs the BC Diagnostic Accreditation Program committee. Coauthor Mel Krajden, MD, reported institutional grants from Roche, Hologic, and Siemens. Dr. Germain and Dr. Quach-Tanh disclosed no competing interests relevant to their comments.
By August 2022, two-and-a-half years into the COVID-19 pandemic, most children as well as most adults under age 60 years had evidence of SARS-CoV-2 vaccination and/or infection, a Canadian seroprevalence study of almost 14,000 people over the first seven waves of the pandemic reports.
However, fewer than 50% people older than age 60, the age group most vulnerable to severe outcomes, showed evidence of immunity from infection or vaccination. The authors noted that older adults – who have the lowest infection rates but highest risk of severe outcomes – continue to warrant prioritized vaccination, writing online in the Canadian Medical Association Journal.
Previous evidence suggests that a combination of both infection and vaccination exposure may induce more robust and durable hybrid immunity than either exposure alone, according to lead author Danuta M. Skowronski, MD, MHSc, an epidemiologist at the British Columbia Centre for Disease Control in Vancouver.
“Our main objective was to chronicle the changing proportion of the population considered immunologically naive and therefore susceptible to SARS-CoV-2,” Dr. Skowronski said in an interview. “It’s relevant for risk assessment to know what proportion have acquired some priming for more efficient immune memory response to the virus because that reduces the likelihood of severe outcomes.” Standardized seroprevalence studies are essential to inform COVID-19 response, particularly in resource-limited regions.
The study
Conducted in British Columbia’s Greater Vancouver and Fraser Valley, the analysis found that in the first year of the pandemic, when extraordinary measures were in place to curtail transmission, virtually everyone remained immunologically naive. Thereafter, however, age-based vaccine rollouts dramatically changed the immuno-epidemiological landscape so that by September 2021, more than 80% of the study population had antibody evidence of immunological priming, while more than 85% remained uninfected.
By August 2022, after the Omicron-variant waves, overall vaccine- and infection-induced seroprevalence exceeded 95%, with 60% having been actually infected, including at least three-quarters of children. Fewer than 50% of older adults, however, showed immunological evidence of exposure.
The study results were based on anonymized residual sera from children and adults in an outpatient laboratory network. At least three immunoassays per serosurvey were used to detect antibodies to SARS-CoV-2 spike (from vaccine) and to nucleocapsid antibodies (from infection).
The researchers assessed any seroprevalence – vaccine-, infection-induced, or both – as defined by positivity on any two assays. Infection-induced seroprevalence was also defined by dual-assay positivity but required both antinucleocapsid and antispike detection. Their estimates of infection-induced seroprevalence indicated considerable under-ascertainment of infections by standard surveillance case reports.
Results
During the first year of the pandemic, fewer than 1% manifested seroprevalence during the first three snapshots and fewer than 5% by January 2021. With vaccine rollout, however, seroprevalence increased dramatically during the first half of 2021 to 56% by May/June 2021 and to 83% by September/October 2021.
In addition, infection-induced seroprevalence was low at less than 15% in September/October 2021 until the arrival of the Omicron waves, after which it rose to 42% by March 2022 and 61% by July/August 2022. Combined seroprevalence for vaccination or infection was more than 95% by the summer, with most children but less than half of adults older than 60 years showing evidence of having been infected.
“We found the highest infection rates among children, closely followed by young adults, which may reflect their greater interconnectedness, including between siblings and parents in the household, as well as with peers in schools and the community,” the authors wrote, adding that the low cumulative infection rates among older adults may reflect their higher vaccination rates and greater social isolation.
U.S. data show similar age-related infection rates, but data among children from other Canadian provinces are limited, the authors said.
Commenting on the survey but not involved in it, infectious diseases expert Marc Germain, MD, PhD, a vice president at Héma-Québec in Quebec City, believes the pattern observed in British Columbia is fairly representative of what happened across Canada and the United States, including the sweeping effect of the Omicron variant and the differential impact according to age.
“But regional differences might very well exist – for example, due to differential vaccine uptake – and are also probably related in part to the different testing platforms being used,” Dr. Germain told this news organization.
Caroline Quach-Tanh, MD, PhD, a pediatrician and epidemiologist/infectologist at the University of Montreal, pointed out that Quebec seroprevalence surveys using residual blood samples from children and adults visiting emergency departments for any reason showed higher rates of prior infection than did the BC surveys. “But Dr. Skowronski’s findings are likely applicable to settings where some nonpharmacological interventions were put in place, but without strict confinement – and thus are likely applicable to most settings in the U.S. and Canada.”
Dr. Quach-Tanh added that there is always a risk of bias with the use of residual blood samples, “but the fact that the study method was stable should have captured a similar population from time to time. It would be unlikely to result in a major overestimation in the proportion of individuals positive for SARS-CoV-2 antibodies.”
A recent global meta-analysis found that while global seroprevalence has risen considerably, albeit variably by region, more than a third of the world’s population is still seronegative to the SARS-CoV-2 virus.
Dr. Skowronski reported institutional grants from the Canadian Institutes of Health Research and the British Columbia Centre for Disease Control Foundation for Public Health for other SARSCoV-2 work. Coauthor Romina C. Reyes, MD, chairs the BC Diagnostic Accreditation Program committee. Coauthor Mel Krajden, MD, reported institutional grants from Roche, Hologic, and Siemens. Dr. Germain and Dr. Quach-Tanh disclosed no competing interests relevant to their comments.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL