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Report may inform first dietary guidelines for Americans from birth to 24 months
The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020.
An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.
The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.
Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.
While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
Promote healthy dietary patterns
The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.
Dr. Meek highlighted some of the advisory committee’s findings and recommendations.
- Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
- Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
- Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
- From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
- The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.
The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
Recommendations during pregnancy
Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.
The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.
Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.
The advisory committee recommended universal folic acid supplementation during pregnancy.
Addressing a gap
The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.
“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.
Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.
Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.
For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.
Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.
To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”
Dr. Meek and Dr. Dewey had no relevant financial disclosures.
The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020.
An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.
The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.
Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.
While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
Promote healthy dietary patterns
The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.
Dr. Meek highlighted some of the advisory committee’s findings and recommendations.
- Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
- Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
- Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
- From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
- The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.
The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
Recommendations during pregnancy
Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.
The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.
Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.
The advisory committee recommended universal folic acid supplementation during pregnancy.
Addressing a gap
The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.
“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.
Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.
Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.
For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.
Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.
To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”
Dr. Meek and Dr. Dewey had no relevant financial disclosures.
The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020.
An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.
The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.
Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.
While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
Promote healthy dietary patterns
The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.
Dr. Meek highlighted some of the advisory committee’s findings and recommendations.
- Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
- Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
- Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
- From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
- The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.
The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
Recommendations during pregnancy
Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.
The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.
Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.
The advisory committee recommended universal folic acid supplementation during pregnancy.
Addressing a gap
The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.
“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.
Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.
Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.
For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.
Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.
To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”
Dr. Meek and Dr. Dewey had no relevant financial disclosures.
FROM AAP 2020
Nearly 10% of hospitalized patients with COVID-19 later readmitted
About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).
Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.
Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.
To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.
Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.
Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).
After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).
They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.
The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.
Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.
“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”
But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.
One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).
Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.
Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.
To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.
Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.
Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).
After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).
They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.
The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.
Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.
“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”
But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.
One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).
Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.
Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.
To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.
Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.
Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).
After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).
They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.
The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.
Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.
“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”
But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.
One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Should our patients really go home for the holidays?
As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. 
Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
What should be considered prior to travel?
Here is a list of points to ponder:
- Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
- What is their mode of transportation?
- What is their destination?
- How prevalent is the disease at their destination, compared with their community?
- What will be their accommodations?
- How will attendees prepare for the gathering, if at all?
- Will multiple families congregate after quarantining for 2 weeks or simply arrive?
- At the destination, will people wear masks and socially distance?
- Is an outdoor venue an option?
All of these questions should be considered by patients.
Review high-risk groups
In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.
Think about transmission and how to mitigate it
Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.
In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.
Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
Ponder modes of transportation
How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.
Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.
For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States.
Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
What should be considered prior to travel?
Here is a list of points to ponder:
- Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
- What is their mode of transportation?
- What is their destination?
- How prevalent is the disease at their destination, compared with their community?
- What will be their accommodations?
- How will attendees prepare for the gathering, if at all?
- Will multiple families congregate after quarantining for 2 weeks or simply arrive?
- At the destination, will people wear masks and socially distance?
- Is an outdoor venue an option?
All of these questions should be considered by patients.
Review high-risk groups
In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.
Think about transmission and how to mitigate it
Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.
In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.
Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
Ponder modes of transportation
How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.
Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.
For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States.
Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
What should be considered prior to travel?
Here is a list of points to ponder:
- Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
- What is their mode of transportation?
- What is their destination?
- How prevalent is the disease at their destination, compared with their community?
- What will be their accommodations?
- How will attendees prepare for the gathering, if at all?
- Will multiple families congregate after quarantining for 2 weeks or simply arrive?
- At the destination, will people wear masks and socially distance?
- Is an outdoor venue an option?
All of these questions should be considered by patients.
Review high-risk groups
In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.
Think about transmission and how to mitigate it
Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.
In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.
Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
Ponder modes of transportation
How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.
Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.
For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
Patients with mental illness a priority for COVID vaccine, experts say
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.
Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.
Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.
In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.
Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.
Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.
Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
High-risk population
Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.
For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.
Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.
Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.
In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.
“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.
The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
An argument for fairness
Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.
“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.
“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.
“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.
Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Nebulized surfactant shows promise in large cohort
Nebulized delivery of surfactant reduced the need for intubation and liquid surfactant administration by half among newborns with signs of respiratory distress syndrome, according to results from a large randomized, multicenter trial.
Neonatologists have long sought alternatives to intubation for administering surfactant to newborns with respiratory distress syndrome (RDS). An effective noninvasive aerosolized treatment has remained elusive, with small clinical trials that have produced mixed results.
In research published in Pediatrics, James J. Cummings, MD, of Albany (N.Y.) Medical Center, and colleagues, randomized 457 infants (mean 33 weeks’ gestational age) with signs of RDS to either usual care or a nebulized bovine surfactant. Infants were recruited at 22 neonatal ICUs in the United States. Investigators were not blinded to treatment allocation and the decision to intubate was left up to the individual treating physician, because to do so, the authors wrote, would add “pragmatic strength” to the study, and “be ethically compliant with the infant’s best interest.”
Infants in the study received usual care or up to three treatments 4 or more hours apart of 35 mg/mL calfactant suspension, 210 mg phospholipid/kg body weight delivered into the mouth through a nebulizer modified with a pacifier. Dr. Cummings and colleagues found that intubation and liquid surfactant administration within the first 4 days after birth was 26% in the intervention group and 50% in the usual care group (P < .001).
The results remained significant after investigators adjusted for gestational age, birth weight, age when randomized, sex, delivery mode, and antenatal steroids. Rates of intubation for surfactant administration were lower for infants in the intervention group in all gestational age brackets except the youngest (23-24 weeks); all of these infants needed intubation. Respiratory support at days 3, 7, and 28 did not differ between study groups.
“Our study is the first to reveal the efficacy of an aerosolized surfactant delivery system that does not require a respiratory circuit interface,” the investigators wrote.
In previous trials of aerosolized surfactants, they noted, treatment was delivered with nasal continuous positive airway pressure. “By using a separate, pacifier interface, both the aerosol delivery and [nasal continuous positive airway pressure] flow can be managed independently, which should allow for safer patient care.”
Dr. Cummings and colleagues also acknowledged several important limitations of their study, including its nonmasked, nonblinded design, and that it enrolled few infants with less than 28 weeks’ gestation. It takes 1-2 hours to deliver aerosolized calfactant, and “we did not want to delay definitive treatment.”
In an editorial comment accompanying the study, Kirsten Glaser, MD, of the University of Leipzig (Germany), and Clyde Wright, MD of the University of Colorado at Denver, Aurora, called the results promising. “Importantly, application of surfactant aerosols was well tolerated by using a modified nebulizer with a pacifier interface.”
“Clinicians were aware that every infant randomly assigned to the nebulized surfactant arm received the intervention,” they wrote. “It is possible that clinicians delayed intubation and endotracheal surfactant instillation in this group, being biased by aerosolization and the hypothesis of lower risk of air leak and lung injury.”
Dr. Glaser and Dr. Wright further lamented that there were no formal criteria for administering surfactant therapy, and that the infants in the study might not be representative of those most in need of treatment. Today, bronchopulmonary dysplasia “primarily affects infants born at less than 28 weeks’ gestational age,” a minority of the infants recruited for this study, they wrote, urging further investigation in this patient group.
In an interview, neonatologist Roger F. Soll, MD, the H. Wallace Professor of Neonatology at the Larner College of Medicine at University of Vermont in Burlington, echoed the editorialists’ concerns that the study’s pragmatic design left a number of key questions unanswered. “It’s a promising study that laudably recruited on an order of magnitude more infants than any like it in the past,” Dr. Soll said. “And the kids who got the therapy seemed to do better, which is exciting. But with the broad entry criteria, the lack of formal diagnosis of RDS, and the outcome measures ultimately potentially biased by lack of blinding, it doesn’t give us the answers we need yet to consider aerosolized treatment.”
ONY Biotech, manufacturer of the study drug Infasurf, sponsored the trial. Dr. Cummings and one coauthor disclosed consulting arrangements with the sponsor, and another coauthor is an employee of the sponsor. The remaining investigators had no relevant financial disclosures. Dr. Glaser and Dr. Wright disclosed no conflicts of interest related to their editorial; Dr. Wright’s work was supported by the National Institutes of Health. Dr. Soll is president of the Vermont Oxford Network and coordinating editor of Cochrane Neonatal.
SOURCE: Cummings JJ et al. Pediatrics. 2020;146(5):e2020021576.
Nebulized delivery of surfactant reduced the need for intubation and liquid surfactant administration by half among newborns with signs of respiratory distress syndrome, according to results from a large randomized, multicenter trial.
Neonatologists have long sought alternatives to intubation for administering surfactant to newborns with respiratory distress syndrome (RDS). An effective noninvasive aerosolized treatment has remained elusive, with small clinical trials that have produced mixed results.
In research published in Pediatrics, James J. Cummings, MD, of Albany (N.Y.) Medical Center, and colleagues, randomized 457 infants (mean 33 weeks’ gestational age) with signs of RDS to either usual care or a nebulized bovine surfactant. Infants were recruited at 22 neonatal ICUs in the United States. Investigators were not blinded to treatment allocation and the decision to intubate was left up to the individual treating physician, because to do so, the authors wrote, would add “pragmatic strength” to the study, and “be ethically compliant with the infant’s best interest.”
Infants in the study received usual care or up to three treatments 4 or more hours apart of 35 mg/mL calfactant suspension, 210 mg phospholipid/kg body weight delivered into the mouth through a nebulizer modified with a pacifier. Dr. Cummings and colleagues found that intubation and liquid surfactant administration within the first 4 days after birth was 26% in the intervention group and 50% in the usual care group (P < .001).
The results remained significant after investigators adjusted for gestational age, birth weight, age when randomized, sex, delivery mode, and antenatal steroids. Rates of intubation for surfactant administration were lower for infants in the intervention group in all gestational age brackets except the youngest (23-24 weeks); all of these infants needed intubation. Respiratory support at days 3, 7, and 28 did not differ between study groups.
“Our study is the first to reveal the efficacy of an aerosolized surfactant delivery system that does not require a respiratory circuit interface,” the investigators wrote.
In previous trials of aerosolized surfactants, they noted, treatment was delivered with nasal continuous positive airway pressure. “By using a separate, pacifier interface, both the aerosol delivery and [nasal continuous positive airway pressure] flow can be managed independently, which should allow for safer patient care.”
Dr. Cummings and colleagues also acknowledged several important limitations of their study, including its nonmasked, nonblinded design, and that it enrolled few infants with less than 28 weeks’ gestation. It takes 1-2 hours to deliver aerosolized calfactant, and “we did not want to delay definitive treatment.”
In an editorial comment accompanying the study, Kirsten Glaser, MD, of the University of Leipzig (Germany), and Clyde Wright, MD of the University of Colorado at Denver, Aurora, called the results promising. “Importantly, application of surfactant aerosols was well tolerated by using a modified nebulizer with a pacifier interface.”
“Clinicians were aware that every infant randomly assigned to the nebulized surfactant arm received the intervention,” they wrote. “It is possible that clinicians delayed intubation and endotracheal surfactant instillation in this group, being biased by aerosolization and the hypothesis of lower risk of air leak and lung injury.”
Dr. Glaser and Dr. Wright further lamented that there were no formal criteria for administering surfactant therapy, and that the infants in the study might not be representative of those most in need of treatment. Today, bronchopulmonary dysplasia “primarily affects infants born at less than 28 weeks’ gestational age,” a minority of the infants recruited for this study, they wrote, urging further investigation in this patient group.
In an interview, neonatologist Roger F. Soll, MD, the H. Wallace Professor of Neonatology at the Larner College of Medicine at University of Vermont in Burlington, echoed the editorialists’ concerns that the study’s pragmatic design left a number of key questions unanswered. “It’s a promising study that laudably recruited on an order of magnitude more infants than any like it in the past,” Dr. Soll said. “And the kids who got the therapy seemed to do better, which is exciting. But with the broad entry criteria, the lack of formal diagnosis of RDS, and the outcome measures ultimately potentially biased by lack of blinding, it doesn’t give us the answers we need yet to consider aerosolized treatment.”
ONY Biotech, manufacturer of the study drug Infasurf, sponsored the trial. Dr. Cummings and one coauthor disclosed consulting arrangements with the sponsor, and another coauthor is an employee of the sponsor. The remaining investigators had no relevant financial disclosures. Dr. Glaser and Dr. Wright disclosed no conflicts of interest related to their editorial; Dr. Wright’s work was supported by the National Institutes of Health. Dr. Soll is president of the Vermont Oxford Network and coordinating editor of Cochrane Neonatal.
SOURCE: Cummings JJ et al. Pediatrics. 2020;146(5):e2020021576.
Nebulized delivery of surfactant reduced the need for intubation and liquid surfactant administration by half among newborns with signs of respiratory distress syndrome, according to results from a large randomized, multicenter trial.
Neonatologists have long sought alternatives to intubation for administering surfactant to newborns with respiratory distress syndrome (RDS). An effective noninvasive aerosolized treatment has remained elusive, with small clinical trials that have produced mixed results.
In research published in Pediatrics, James J. Cummings, MD, of Albany (N.Y.) Medical Center, and colleagues, randomized 457 infants (mean 33 weeks’ gestational age) with signs of RDS to either usual care or a nebulized bovine surfactant. Infants were recruited at 22 neonatal ICUs in the United States. Investigators were not blinded to treatment allocation and the decision to intubate was left up to the individual treating physician, because to do so, the authors wrote, would add “pragmatic strength” to the study, and “be ethically compliant with the infant’s best interest.”
Infants in the study received usual care or up to three treatments 4 or more hours apart of 35 mg/mL calfactant suspension, 210 mg phospholipid/kg body weight delivered into the mouth through a nebulizer modified with a pacifier. Dr. Cummings and colleagues found that intubation and liquid surfactant administration within the first 4 days after birth was 26% in the intervention group and 50% in the usual care group (P < .001).
The results remained significant after investigators adjusted for gestational age, birth weight, age when randomized, sex, delivery mode, and antenatal steroids. Rates of intubation for surfactant administration were lower for infants in the intervention group in all gestational age brackets except the youngest (23-24 weeks); all of these infants needed intubation. Respiratory support at days 3, 7, and 28 did not differ between study groups.
“Our study is the first to reveal the efficacy of an aerosolized surfactant delivery system that does not require a respiratory circuit interface,” the investigators wrote.
In previous trials of aerosolized surfactants, they noted, treatment was delivered with nasal continuous positive airway pressure. “By using a separate, pacifier interface, both the aerosol delivery and [nasal continuous positive airway pressure] flow can be managed independently, which should allow for safer patient care.”
Dr. Cummings and colleagues also acknowledged several important limitations of their study, including its nonmasked, nonblinded design, and that it enrolled few infants with less than 28 weeks’ gestation. It takes 1-2 hours to deliver aerosolized calfactant, and “we did not want to delay definitive treatment.”
In an editorial comment accompanying the study, Kirsten Glaser, MD, of the University of Leipzig (Germany), and Clyde Wright, MD of the University of Colorado at Denver, Aurora, called the results promising. “Importantly, application of surfactant aerosols was well tolerated by using a modified nebulizer with a pacifier interface.”
“Clinicians were aware that every infant randomly assigned to the nebulized surfactant arm received the intervention,” they wrote. “It is possible that clinicians delayed intubation and endotracheal surfactant instillation in this group, being biased by aerosolization and the hypothesis of lower risk of air leak and lung injury.”
Dr. Glaser and Dr. Wright further lamented that there were no formal criteria for administering surfactant therapy, and that the infants in the study might not be representative of those most in need of treatment. Today, bronchopulmonary dysplasia “primarily affects infants born at less than 28 weeks’ gestational age,” a minority of the infants recruited for this study, they wrote, urging further investigation in this patient group.
In an interview, neonatologist Roger F. Soll, MD, the H. Wallace Professor of Neonatology at the Larner College of Medicine at University of Vermont in Burlington, echoed the editorialists’ concerns that the study’s pragmatic design left a number of key questions unanswered. “It’s a promising study that laudably recruited on an order of magnitude more infants than any like it in the past,” Dr. Soll said. “And the kids who got the therapy seemed to do better, which is exciting. But with the broad entry criteria, the lack of formal diagnosis of RDS, and the outcome measures ultimately potentially biased by lack of blinding, it doesn’t give us the answers we need yet to consider aerosolized treatment.”
ONY Biotech, manufacturer of the study drug Infasurf, sponsored the trial. Dr. Cummings and one coauthor disclosed consulting arrangements with the sponsor, and another coauthor is an employee of the sponsor. The remaining investigators had no relevant financial disclosures. Dr. Glaser and Dr. Wright disclosed no conflicts of interest related to their editorial; Dr. Wright’s work was supported by the National Institutes of Health. Dr. Soll is president of the Vermont Oxford Network and coordinating editor of Cochrane Neonatal.
SOURCE: Cummings JJ et al. Pediatrics. 2020;146(5):e2020021576.
FROM PEDIATRICS
The future of pediatrics
Things will change. That is a constant. The practice of pediatrics will be different in the future. The pandemic has changed some things; mostly it has accelerated changes, advancements, improvements, and losses that were already occurring. Telemedicine will play a more prominent role in the future. The finances of solo and small-group practice have become more difficult.
As I wrote my prior column on the character traits/virtues of an admirable physician, I also began brainstorming this column on the traits of an admirable profession. Then the American Academy of Pediatrics’ virtual National Conference & Exhibition had many presentations encouraging pediatricians to adopt a conglomeration of activities in their offices. I became skeptical. Which should be selected? To make a wise choice, I review the major goals of medicine, which I have evolved to embrace as the quadruple aims.
First and hopefully always foremost, the health professions are dedicated to the health of their patients and, hopefully, the population at large. This trait dates to the Hippocratic Oath.
Second, physicians have a stewardship over a vast collection of knowledge, skills, resources, and funds. When I started my career, U.S. health care had increased from 6% of the gross domestic product to 9%, nearly twice that of other developed nations, and was expanding rapidly, contributing to widespread economic problems including the national debt. The health economists of the 1980’s made dire predictions that the nation was headed up to 12% of the GDP, which would cause the sky to start falling. Last I checked U.S. health care is approaching 18% of the GDP. The sky seems intact, although the oceans are rising and the hillsides are burning.
Managed care of the 1990s became focused on the consumer experience. Evaluations of physicians and nurses became dependent on consumer surveys. I recall one survey about the care I personally had received as day surgery. It was mostly about scheduling, being greeted on arrival, the waiting room, and other fluff. Only 1 of the over 20 questions had any bearing on whether I thought the diagnosis was correct, the treatment was effective, or my physician was competent. As a cancer patient, my priorities were not aligned with that survey’s concept of quality.
From 2008, I recall the Triple Aim: “Improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care.”
Over the ensuing decade, physician wellness has been added to make a quadruple aim. If the system isn’t professionally rewarding, burnout occurs. Skills and experience are lost. The best and brightest are not attracted to the specialty. Quality goes down. So physicians must factor this into decisions about the future of pediatrics.
There are many social determinants of health that have large impacts on the population health of children, and it does not necessarily follow that I should spend my patient care time on those determinants. As a professional, I have a responsibility to ensure that I am treating important problems that match my extensive (and expensive) training, knowledge, skills, and experience.
I recently read a persuasive argument that caring for ADHD is an important and doable part of modern general pediatrics. I agree, but I agreed with the proponent’s idea 25 years ago when I joined a large group and saw my own ADHD patients. Change can be slow.
Pharmacology options for anxiety have become safer, more effective, and better understood in children. General pediatricians may now be able to provide important, earlier, and accessible intervention for pediatric anxiety and other mental health issues.
Food insecurity is a worsening issue during the pandemic, but not one which I have specialized abilities to address. A brochure listing available local resources could be posted in waiting rooms and exam rooms. Is spending time asking about it during a visit the best use of a pediatrician’s time? That is a choice a professional needs to make. It may depend on your patient panel and community resources. In the past, I was more inclined to focus on medical care and donate the extra income to my church’s food bank. But the world has changed. Perhaps the pediatrician’s office of the 2020s is a department store, with social workers, psychologists, and therapists located under the same roof. It reminds me of the Mayo model. Wealthy people would travel to Rochester for an executive physical. That physical would frequently recommend seeing a couple specialists before leaving town. It is an effective model but also luxurious.
Racism causes major harms, both to physical health and mental health. Is asking about it a wise use of limited time for well-child visits? What resources will you offer?
Climate change, hurricanes, and wildfires are harming children. Is debating the issue with your patient’s parents productive? I am zealous about the topic. I spend considerable time and money promoting the credibility of science within various religious organizations, but I try to avoid bringing politics into my interactions with patients.
As a professional, your choices may be different. Many people are telling you what you should care about. The executive well-child visit would be beneficial, but it would also take 2 hours. Don’t be misled into spending too much effort on issues not in your expertise. Choose wisely.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Things will change. That is a constant. The practice of pediatrics will be different in the future. The pandemic has changed some things; mostly it has accelerated changes, advancements, improvements, and losses that were already occurring. Telemedicine will play a more prominent role in the future. The finances of solo and small-group practice have become more difficult.
As I wrote my prior column on the character traits/virtues of an admirable physician, I also began brainstorming this column on the traits of an admirable profession. Then the American Academy of Pediatrics’ virtual National Conference & Exhibition had many presentations encouraging pediatricians to adopt a conglomeration of activities in their offices. I became skeptical. Which should be selected? To make a wise choice, I review the major goals of medicine, which I have evolved to embrace as the quadruple aims.
First and hopefully always foremost, the health professions are dedicated to the health of their patients and, hopefully, the population at large. This trait dates to the Hippocratic Oath.
Second, physicians have a stewardship over a vast collection of knowledge, skills, resources, and funds. When I started my career, U.S. health care had increased from 6% of the gross domestic product to 9%, nearly twice that of other developed nations, and was expanding rapidly, contributing to widespread economic problems including the national debt. The health economists of the 1980’s made dire predictions that the nation was headed up to 12% of the GDP, which would cause the sky to start falling. Last I checked U.S. health care is approaching 18% of the GDP. The sky seems intact, although the oceans are rising and the hillsides are burning.
Managed care of the 1990s became focused on the consumer experience. Evaluations of physicians and nurses became dependent on consumer surveys. I recall one survey about the care I personally had received as day surgery. It was mostly about scheduling, being greeted on arrival, the waiting room, and other fluff. Only 1 of the over 20 questions had any bearing on whether I thought the diagnosis was correct, the treatment was effective, or my physician was competent. As a cancer patient, my priorities were not aligned with that survey’s concept of quality.
From 2008, I recall the Triple Aim: “Improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care.”
Over the ensuing decade, physician wellness has been added to make a quadruple aim. If the system isn’t professionally rewarding, burnout occurs. Skills and experience are lost. The best and brightest are not attracted to the specialty. Quality goes down. So physicians must factor this into decisions about the future of pediatrics.
There are many social determinants of health that have large impacts on the population health of children, and it does not necessarily follow that I should spend my patient care time on those determinants. As a professional, I have a responsibility to ensure that I am treating important problems that match my extensive (and expensive) training, knowledge, skills, and experience.
I recently read a persuasive argument that caring for ADHD is an important and doable part of modern general pediatrics. I agree, but I agreed with the proponent’s idea 25 years ago when I joined a large group and saw my own ADHD patients. Change can be slow.
Pharmacology options for anxiety have become safer, more effective, and better understood in children. General pediatricians may now be able to provide important, earlier, and accessible intervention for pediatric anxiety and other mental health issues.
Food insecurity is a worsening issue during the pandemic, but not one which I have specialized abilities to address. A brochure listing available local resources could be posted in waiting rooms and exam rooms. Is spending time asking about it during a visit the best use of a pediatrician’s time? That is a choice a professional needs to make. It may depend on your patient panel and community resources. In the past, I was more inclined to focus on medical care and donate the extra income to my church’s food bank. But the world has changed. Perhaps the pediatrician’s office of the 2020s is a department store, with social workers, psychologists, and therapists located under the same roof. It reminds me of the Mayo model. Wealthy people would travel to Rochester for an executive physical. That physical would frequently recommend seeing a couple specialists before leaving town. It is an effective model but also luxurious.
Racism causes major harms, both to physical health and mental health. Is asking about it a wise use of limited time for well-child visits? What resources will you offer?
Climate change, hurricanes, and wildfires are harming children. Is debating the issue with your patient’s parents productive? I am zealous about the topic. I spend considerable time and money promoting the credibility of science within various religious organizations, but I try to avoid bringing politics into my interactions with patients.
As a professional, your choices may be different. Many people are telling you what you should care about. The executive well-child visit would be beneficial, but it would also take 2 hours. Don’t be misled into spending too much effort on issues not in your expertise. Choose wisely.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Things will change. That is a constant. The practice of pediatrics will be different in the future. The pandemic has changed some things; mostly it has accelerated changes, advancements, improvements, and losses that were already occurring. Telemedicine will play a more prominent role in the future. The finances of solo and small-group practice have become more difficult.
As I wrote my prior column on the character traits/virtues of an admirable physician, I also began brainstorming this column on the traits of an admirable profession. Then the American Academy of Pediatrics’ virtual National Conference & Exhibition had many presentations encouraging pediatricians to adopt a conglomeration of activities in their offices. I became skeptical. Which should be selected? To make a wise choice, I review the major goals of medicine, which I have evolved to embrace as the quadruple aims.
First and hopefully always foremost, the health professions are dedicated to the health of their patients and, hopefully, the population at large. This trait dates to the Hippocratic Oath.
Second, physicians have a stewardship over a vast collection of knowledge, skills, resources, and funds. When I started my career, U.S. health care had increased from 6% of the gross domestic product to 9%, nearly twice that of other developed nations, and was expanding rapidly, contributing to widespread economic problems including the national debt. The health economists of the 1980’s made dire predictions that the nation was headed up to 12% of the GDP, which would cause the sky to start falling. Last I checked U.S. health care is approaching 18% of the GDP. The sky seems intact, although the oceans are rising and the hillsides are burning.
Managed care of the 1990s became focused on the consumer experience. Evaluations of physicians and nurses became dependent on consumer surveys. I recall one survey about the care I personally had received as day surgery. It was mostly about scheduling, being greeted on arrival, the waiting room, and other fluff. Only 1 of the over 20 questions had any bearing on whether I thought the diagnosis was correct, the treatment was effective, or my physician was competent. As a cancer patient, my priorities were not aligned with that survey’s concept of quality.
From 2008, I recall the Triple Aim: “Improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care.”
Over the ensuing decade, physician wellness has been added to make a quadruple aim. If the system isn’t professionally rewarding, burnout occurs. Skills and experience are lost. The best and brightest are not attracted to the specialty. Quality goes down. So physicians must factor this into decisions about the future of pediatrics.
There are many social determinants of health that have large impacts on the population health of children, and it does not necessarily follow that I should spend my patient care time on those determinants. As a professional, I have a responsibility to ensure that I am treating important problems that match my extensive (and expensive) training, knowledge, skills, and experience.
I recently read a persuasive argument that caring for ADHD is an important and doable part of modern general pediatrics. I agree, but I agreed with the proponent’s idea 25 years ago when I joined a large group and saw my own ADHD patients. Change can be slow.
Pharmacology options for anxiety have become safer, more effective, and better understood in children. General pediatricians may now be able to provide important, earlier, and accessible intervention for pediatric anxiety and other mental health issues.
Food insecurity is a worsening issue during the pandemic, but not one which I have specialized abilities to address. A brochure listing available local resources could be posted in waiting rooms and exam rooms. Is spending time asking about it during a visit the best use of a pediatrician’s time? That is a choice a professional needs to make. It may depend on your patient panel and community resources. In the past, I was more inclined to focus on medical care and donate the extra income to my church’s food bank. But the world has changed. Perhaps the pediatrician’s office of the 2020s is a department store, with social workers, psychologists, and therapists located under the same roof. It reminds me of the Mayo model. Wealthy people would travel to Rochester for an executive physical. That physical would frequently recommend seeing a couple specialists before leaving town. It is an effective model but also luxurious.
Racism causes major harms, both to physical health and mental health. Is asking about it a wise use of limited time for well-child visits? What resources will you offer?
Climate change, hurricanes, and wildfires are harming children. Is debating the issue with your patient’s parents productive? I am zealous about the topic. I spend considerable time and money promoting the credibility of science within various religious organizations, but I try to avoid bringing politics into my interactions with patients.
As a professional, your choices may be different. Many people are telling you what you should care about. The executive well-child visit would be beneficial, but it would also take 2 hours. Don’t be misled into spending too much effort on issues not in your expertise. Choose wisely.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Poverty raises depression risk in patients with cystic fibrosis
Poor people with chronic illness have greater difficulty managing their disease than do their better-off counterparts, and a new study confirms this reality for patients with cystic fibrosis.
and anxiety symptoms, according to a new cross-sectional study. The data were drawn from the Cystic Fibrosis Foundation’s Success with Therapies Research Consortium.
“Assessing the special challenges that individuals with lower SES face, including financial barriers, is essential to understand how we can address the unique combinations of adherence barriers. In other chronic disorders, financial barriers or lower socioeconomic status is associated with nonadherence, but this relationship has not been well established in cystic fibrosis,” said Kimberly Dickinson, MD, MPH, of Johns Hopkins University, Baltimore, during her presentation of the results at the virtual North American Cystic Fibrosis Conference.
“I’ve always thought that my patients in the poorer population were doing worse, and I think this demonstrates that that’s true,” said Robert Giusti, MD, in an interview. Dr. Giusti is a clinical professor of pediatrics at the New York University and director of the Pediatric Cystic Fibrosis Center in New York. He was not involved in the study.
“These are very pertinent issues, especially if you think about the pandemic, and some of the issues related to mental health. It just highlights the importance of socioeconomic status and screening for some of the known risk factors so that we can develop interventions or programs to provide equitable care to all of our cystic fibrosis patients,” said Ryan Perkins, MD, who moderated the session where the study was presented. He is a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, also in Boston.
The researchers looked retrospectively at 1 year’s worth of pharmacy refill receipts and number of times prescriptions were refilled versus the number of times prescribed, then calculated medicinal possession ratios. This was cross-referenced with annual household income and insurance status of patients with CF at 12 pediatric and 9 adult CF care centers, for a total of 376 patients (128 pediatric and 248 adult).
In this population, 32% of participants had public or no insurance, 68% had private or military insurance. The public/no insurance group was more likely than the private/military insurance group to report having trouble paying for treatments, food, or critical expenses related to CF care (23.3% vs. 12.1%, respectively); feeling symptoms on most days of depression (42.5% vs. 31.3%) or anxiety (40.0% vs. 28.5%); and experiencing conflict or stress with loved ones over treatments (30.0% vs. 20.3%) (P < .05 for all).
In all, 35% had a household income less than $40,000 per year, 33% between $44,000 and $100,000, and 32% higher than $100,000. The low-income group had a lower composite medication possession ratio (0.41) than the middle- (0.44) or high-income (0.52) groups, were more likely to have trouble paying for treatments, food, or treatment-related expenses (25%, 18%, 4%, respectively); were more likely most days to report symptoms of depression (43%, 34%, 26%) or anxiety (40%, 32%, 24%), and to have concerns about whether treatments were effective (42%, 27%, 29%). They were more likely to not be able to maintain a daily schedule or routine for treatments (28%, 22%, 14%).
The study showed that adherence barriers and suboptimal adherence are issues that cross all socioeconomic categories, though they were more problematic in the lowest bracket. Greater anxiety and depression among lower income individuals and those with private or no insurance was a key finding, according to Dr. Dickinson. “It highlights the importance of screening for mental health comorbidities that may impact non-adherence,” she said.
The study received funding from the Cystic Fibrosis Foundation. Dr. Dickinson, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
Poor people with chronic illness have greater difficulty managing their disease than do their better-off counterparts, and a new study confirms this reality for patients with cystic fibrosis.
and anxiety symptoms, according to a new cross-sectional study. The data were drawn from the Cystic Fibrosis Foundation’s Success with Therapies Research Consortium.
“Assessing the special challenges that individuals with lower SES face, including financial barriers, is essential to understand how we can address the unique combinations of adherence barriers. In other chronic disorders, financial barriers or lower socioeconomic status is associated with nonadherence, but this relationship has not been well established in cystic fibrosis,” said Kimberly Dickinson, MD, MPH, of Johns Hopkins University, Baltimore, during her presentation of the results at the virtual North American Cystic Fibrosis Conference.
“I’ve always thought that my patients in the poorer population were doing worse, and I think this demonstrates that that’s true,” said Robert Giusti, MD, in an interview. Dr. Giusti is a clinical professor of pediatrics at the New York University and director of the Pediatric Cystic Fibrosis Center in New York. He was not involved in the study.
“These are very pertinent issues, especially if you think about the pandemic, and some of the issues related to mental health. It just highlights the importance of socioeconomic status and screening for some of the known risk factors so that we can develop interventions or programs to provide equitable care to all of our cystic fibrosis patients,” said Ryan Perkins, MD, who moderated the session where the study was presented. He is a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, also in Boston.
The researchers looked retrospectively at 1 year’s worth of pharmacy refill receipts and number of times prescriptions were refilled versus the number of times prescribed, then calculated medicinal possession ratios. This was cross-referenced with annual household income and insurance status of patients with CF at 12 pediatric and 9 adult CF care centers, for a total of 376 patients (128 pediatric and 248 adult).
In this population, 32% of participants had public or no insurance, 68% had private or military insurance. The public/no insurance group was more likely than the private/military insurance group to report having trouble paying for treatments, food, or critical expenses related to CF care (23.3% vs. 12.1%, respectively); feeling symptoms on most days of depression (42.5% vs. 31.3%) or anxiety (40.0% vs. 28.5%); and experiencing conflict or stress with loved ones over treatments (30.0% vs. 20.3%) (P < .05 for all).
In all, 35% had a household income less than $40,000 per year, 33% between $44,000 and $100,000, and 32% higher than $100,000. The low-income group had a lower composite medication possession ratio (0.41) than the middle- (0.44) or high-income (0.52) groups, were more likely to have trouble paying for treatments, food, or treatment-related expenses (25%, 18%, 4%, respectively); were more likely most days to report symptoms of depression (43%, 34%, 26%) or anxiety (40%, 32%, 24%), and to have concerns about whether treatments were effective (42%, 27%, 29%). They were more likely to not be able to maintain a daily schedule or routine for treatments (28%, 22%, 14%).
The study showed that adherence barriers and suboptimal adherence are issues that cross all socioeconomic categories, though they were more problematic in the lowest bracket. Greater anxiety and depression among lower income individuals and those with private or no insurance was a key finding, according to Dr. Dickinson. “It highlights the importance of screening for mental health comorbidities that may impact non-adherence,” she said.
The study received funding from the Cystic Fibrosis Foundation. Dr. Dickinson, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
Poor people with chronic illness have greater difficulty managing their disease than do their better-off counterparts, and a new study confirms this reality for patients with cystic fibrosis.
and anxiety symptoms, according to a new cross-sectional study. The data were drawn from the Cystic Fibrosis Foundation’s Success with Therapies Research Consortium.
“Assessing the special challenges that individuals with lower SES face, including financial barriers, is essential to understand how we can address the unique combinations of adherence barriers. In other chronic disorders, financial barriers or lower socioeconomic status is associated with nonadherence, but this relationship has not been well established in cystic fibrosis,” said Kimberly Dickinson, MD, MPH, of Johns Hopkins University, Baltimore, during her presentation of the results at the virtual North American Cystic Fibrosis Conference.
“I’ve always thought that my patients in the poorer population were doing worse, and I think this demonstrates that that’s true,” said Robert Giusti, MD, in an interview. Dr. Giusti is a clinical professor of pediatrics at the New York University and director of the Pediatric Cystic Fibrosis Center in New York. He was not involved in the study.
“These are very pertinent issues, especially if you think about the pandemic, and some of the issues related to mental health. It just highlights the importance of socioeconomic status and screening for some of the known risk factors so that we can develop interventions or programs to provide equitable care to all of our cystic fibrosis patients,” said Ryan Perkins, MD, who moderated the session where the study was presented. He is a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, also in Boston.
The researchers looked retrospectively at 1 year’s worth of pharmacy refill receipts and number of times prescriptions were refilled versus the number of times prescribed, then calculated medicinal possession ratios. This was cross-referenced with annual household income and insurance status of patients with CF at 12 pediatric and 9 adult CF care centers, for a total of 376 patients (128 pediatric and 248 adult).
In this population, 32% of participants had public or no insurance, 68% had private or military insurance. The public/no insurance group was more likely than the private/military insurance group to report having trouble paying for treatments, food, or critical expenses related to CF care (23.3% vs. 12.1%, respectively); feeling symptoms on most days of depression (42.5% vs. 31.3%) or anxiety (40.0% vs. 28.5%); and experiencing conflict or stress with loved ones over treatments (30.0% vs. 20.3%) (P < .05 for all).
In all, 35% had a household income less than $40,000 per year, 33% between $44,000 and $100,000, and 32% higher than $100,000. The low-income group had a lower composite medication possession ratio (0.41) than the middle- (0.44) or high-income (0.52) groups, were more likely to have trouble paying for treatments, food, or treatment-related expenses (25%, 18%, 4%, respectively); were more likely most days to report symptoms of depression (43%, 34%, 26%) or anxiety (40%, 32%, 24%), and to have concerns about whether treatments were effective (42%, 27%, 29%). They were more likely to not be able to maintain a daily schedule or routine for treatments (28%, 22%, 14%).
The study showed that adherence barriers and suboptimal adherence are issues that cross all socioeconomic categories, though they were more problematic in the lowest bracket. Greater anxiety and depression among lower income individuals and those with private or no insurance was a key finding, according to Dr. Dickinson. “It highlights the importance of screening for mental health comorbidities that may impact non-adherence,” she said.
The study received funding from the Cystic Fibrosis Foundation. Dr. Dickinson, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
FROM NACFC 2020
.
Biden plan to lower Medicare eligibility age to 60 faces hostility from hospitals
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.
But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.
Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort.
“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.
Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.
“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.
Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.
“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.
Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)
Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.
Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.
Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.
Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.
To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.
The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.
“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.
The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.
While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.
Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.
Avalere says 3.2 million people in that age group buy coverage on the individual market.
While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.
About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.
Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.
Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.
“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.
President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.
Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.
Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.
Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.
“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Dripping, dabbing, and bongs: Can’t tell the players without a scorecard
E-cigarettes may be synonymous with vaping to most physicians, but there are other ways for patients to inhale nicotine or tetrahydrocannabinol-containing aerosols, according to investigators at the Cleveland Clinic. 
Humberto Choi, MD, and associates wrote in the Annals of the American Thoracic Society.
These “alternate aerosol inhalation methods” have been poorly described thus far, so little is known about their scope of use and potential health impact, they noted.
Dripping involves an e-cigarette modified to expose the heating coil. The e-cigarette liquid is dripped directly onto the hot coil, which produces immediate aerosolization and results in a thicker cloud.
Dripping “may expose users to higher levels of nicotine compared to e-cigarette inhalation” and lead to “increased release of volatile aldehydes as a result of the higher heating potential of direct atomizer exposure,” the investigators suggested.
Water pipes, or bongs, produce both smoke and vapor, although an electronic vaporizer can be attached to create a “vape bong.” About 21% of daily cannabis users report using a bong, but tobacco inhalation is less common. Cases of severe pulmonary infections have been associated with bong use, along with a couple of tuberculosis clusters, Dr. Choi and associates said.
Dabbing uses butane-extracted, concentrated cannabis oil inhaled through a modified water pipe or bong or a smaller device called a “dab pen.” A small amount, or “dab,” of the product is placed on the “nail,” which replaces the bowl of the water pipe, heated with a blowtorch, and inhaled through the pipe, the researchers explained.
The prevalence of dabbing is unknown, but “the most recent Monitoring the Future survey of high school seniors shows that 11.9% of students have used a marijuana vaporizer at some point in their life,” they said.
Besides the fire risks involved in creating the material needed for dabbing – use of heating plates, ovens, and devices for removing butane vapors – inhalation of residual butane vapors could lead to vomiting, cardiac arrhythmias, acute encephalopathy, and respiratory depression, Dr. Choi and associates said.
Nicotine dependence is also a concern, as is the possibility of withdrawal symptoms. “Patients presenting with prolonged and severe vomiting, psychotic symptoms, or other acute neuropsychiatric symptoms should raise the suspicion of [tetrahydrocannabinol]-containing products especially synthetic cannabinoids,” they wrote.
SOURCE: Choi H et al. Ann Am Thorac Soc. 2020 Oct 14. doi: 10.1513/AnnalsATS.202005-511CME.
E-cigarettes may be synonymous with vaping to most physicians, but there are other ways for patients to inhale nicotine or tetrahydrocannabinol-containing aerosols, according to investigators at the Cleveland Clinic.
Humberto Choi, MD, and associates wrote in the Annals of the American Thoracic Society.
These “alternate aerosol inhalation methods” have been poorly described thus far, so little is known about their scope of use and potential health impact, they noted.
Dripping involves an e-cigarette modified to expose the heating coil. The e-cigarette liquid is dripped directly onto the hot coil, which produces immediate aerosolization and results in a thicker cloud.
Dripping “may expose users to higher levels of nicotine compared to e-cigarette inhalation” and lead to “increased release of volatile aldehydes as a result of the higher heating potential of direct atomizer exposure,” the investigators suggested.
Water pipes, or bongs, produce both smoke and vapor, although an electronic vaporizer can be attached to create a “vape bong.” About 21% of daily cannabis users report using a bong, but tobacco inhalation is less common. Cases of severe pulmonary infections have been associated with bong use, along with a couple of tuberculosis clusters, Dr. Choi and associates said.
Dabbing uses butane-extracted, concentrated cannabis oil inhaled through a modified water pipe or bong or a smaller device called a “dab pen.” A small amount, or “dab,” of the product is placed on the “nail,” which replaces the bowl of the water pipe, heated with a blowtorch, and inhaled through the pipe, the researchers explained.
The prevalence of dabbing is unknown, but “the most recent Monitoring the Future survey of high school seniors shows that 11.9% of students have used a marijuana vaporizer at some point in their life,” they said.
Besides the fire risks involved in creating the material needed for dabbing – use of heating plates, ovens, and devices for removing butane vapors – inhalation of residual butane vapors could lead to vomiting, cardiac arrhythmias, acute encephalopathy, and respiratory depression, Dr. Choi and associates said.
Nicotine dependence is also a concern, as is the possibility of withdrawal symptoms. “Patients presenting with prolonged and severe vomiting, psychotic symptoms, or other acute neuropsychiatric symptoms should raise the suspicion of [tetrahydrocannabinol]-containing products especially synthetic cannabinoids,” they wrote.
SOURCE: Choi H et al. Ann Am Thorac Soc. 2020 Oct 14. doi: 10.1513/AnnalsATS.202005-511CME.
E-cigarettes may be synonymous with vaping to most physicians, but there are other ways for patients to inhale nicotine or tetrahydrocannabinol-containing aerosols, according to investigators at the Cleveland Clinic.
Humberto Choi, MD, and associates wrote in the Annals of the American Thoracic Society.
These “alternate aerosol inhalation methods” have been poorly described thus far, so little is known about their scope of use and potential health impact, they noted.
Dripping involves an e-cigarette modified to expose the heating coil. The e-cigarette liquid is dripped directly onto the hot coil, which produces immediate aerosolization and results in a thicker cloud.
Dripping “may expose users to higher levels of nicotine compared to e-cigarette inhalation” and lead to “increased release of volatile aldehydes as a result of the higher heating potential of direct atomizer exposure,” the investigators suggested.
Water pipes, or bongs, produce both smoke and vapor, although an electronic vaporizer can be attached to create a “vape bong.” About 21% of daily cannabis users report using a bong, but tobacco inhalation is less common. Cases of severe pulmonary infections have been associated with bong use, along with a couple of tuberculosis clusters, Dr. Choi and associates said.
Dabbing uses butane-extracted, concentrated cannabis oil inhaled through a modified water pipe or bong or a smaller device called a “dab pen.” A small amount, or “dab,” of the product is placed on the “nail,” which replaces the bowl of the water pipe, heated with a blowtorch, and inhaled through the pipe, the researchers explained.
The prevalence of dabbing is unknown, but “the most recent Monitoring the Future survey of high school seniors shows that 11.9% of students have used a marijuana vaporizer at some point in their life,” they said.
Besides the fire risks involved in creating the material needed for dabbing – use of heating plates, ovens, and devices for removing butane vapors – inhalation of residual butane vapors could lead to vomiting, cardiac arrhythmias, acute encephalopathy, and respiratory depression, Dr. Choi and associates said.
Nicotine dependence is also a concern, as is the possibility of withdrawal symptoms. “Patients presenting with prolonged and severe vomiting, psychotic symptoms, or other acute neuropsychiatric symptoms should raise the suspicion of [tetrahydrocannabinol]-containing products especially synthetic cannabinoids,” they wrote.
SOURCE: Choi H et al. Ann Am Thorac Soc. 2020 Oct 14. doi: 10.1513/AnnalsATS.202005-511CME.
FROM ANNALS OF THE AMERICAN THORACIC SOCIETY
Search for a snakebite drug might lead to a COVID treatment, too
Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.
The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.
“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.
It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.
His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.
Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.
Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.
Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.
The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.
The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.
The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.
Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.
It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.
A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.
“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”
That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.
Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.
Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.
Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.
If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.
He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.
The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”
With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.
Dr. Lewin then conducted tests on mice and pigs. Both were successful.
Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.
Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.
“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.
The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.
Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.
More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.
Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.
The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.
“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.
It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.
His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.
Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.
Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.
Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.
The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.
The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.
The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.
Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.
It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.
A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.
“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”
That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.
Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.
Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.
Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.
If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.
He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.
The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”
With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.
Dr. Lewin then conducted tests on mice and pigs. Both were successful.
Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.
Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.
“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.
The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.
Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.
More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.
Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.
The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.
“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.
It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.
His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.
Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.
Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.
Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.
The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.
The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.
The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.
Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.
It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.
A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.
“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”
That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.
Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.
Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.
Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.
If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.
He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.
The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”
With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.
Dr. Lewin then conducted tests on mice and pigs. Both were successful.
Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.
Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.
“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.
The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.
Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.
More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.
Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.