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New deep dive into Paxlovid interactions with CVD meds
Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.
COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.
“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.
“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”
The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.
It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.
Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.
“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.
When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.
For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.
Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.
Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.
While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.
“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”
Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.
The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.
Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.
“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.
“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.
COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.
“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.
“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”
The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.
It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.
Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.
“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.
When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.
For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.
Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.
Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.
While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.
“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”
Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.
The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.
Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.
“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.
“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.
COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.
“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.
“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”
The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.
It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.
Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.
“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.
When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.
For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.
Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.
Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.
While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.
“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”
Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.
The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.
Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.
“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.
“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
The marked contrast in pandemic outcomes between Japan and the United States
This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack.
Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.
Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.
Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.
Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.
But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.
Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.
And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.
Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.
Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.
There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.
That’s why I had previously modified the Swiss cheese model to add Paxlovid.
But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.
Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.
No less the previous data through May 2022 showing protection from death across all ages with two boosters
And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.
We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.
Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.
This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack.
Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.
Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.
Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.
Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.
But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.
Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.
And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.
Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.
Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.
There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.
That’s why I had previously modified the Swiss cheese model to add Paxlovid.
But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.
Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.
No less the previous data through May 2022 showing protection from death across all ages with two boosters
And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.
We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.
Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.
This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack.
Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.
Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.
Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.
Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.
But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.
Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.
And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.
Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.
Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.
There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.
That’s why I had previously modified the Swiss cheese model to add Paxlovid.
But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.
Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.
No less the previous data through May 2022 showing protection from death across all ages with two boosters
And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.
We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.
Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.
Does an early COPD diagnosis improve long-term outcomes?
EVIDENCE SUMMARY
Early Dx didn’t improve smoking cessation rates or treatment outcomes
A 2016 evidence report and systematic review for the US Preventive Services Task Force (USPSTF) identified no studies directly comparing the effectiveness of COPD screening on patient outcomes, so the authors looked first at studies on the outcomes of screening, followed by studies exploring the effects of early treatment.1
The authors identified 5 fair-quality RCTs (N = 1694) addressing the effect of screening asymptomatic patients for COPD with spirometry on the outcome of smoking cessation. One trial (n = 561) found better 12-month smoking cessation rates in patients who underwent spirometry screening and were given their “lung age” (13.6% vs 6.4% not given a lung age; P < .005; number needed to treat [NNT] = 14). However, a similar study (n = 542) published a year later found no significant difference in quit rates with or without “lung age” discussions (10.9% vs 13%, respectively; P not significant). In the other 3 studies, screening produced no significant effect on smoking cessation rates.1
As for possible early treatment benefits, the review authors identified only 1 RCT (n = 1175) that included any patients with mild COPD (defined as COPD with a forced expiratory volume in 1 second [FEV1] ≥ 80% of predicted normal value). It assessed treatment with inhaled corticosteroids (ICS) in patients with mild COPD who continued to smoke. The trial did not record symptoms (if any) at intake. ICS therapy reduced the frequency of COPD exacerbations (relative risk = 0.63; 95% CI, 0.47-0.85), although patients with milder COPD benefitted little in absolute terms (by 0.02 exacerbations/year).1 The review authors further noted that data were insufficient to make definitive statements about the effect of ICS on dyspnea or health-related quality of life.
But later diagnosis is associated with poorer outcomes
Two recent, large retrospective observational cohort studies, however, have examined the impact of an early vs late COPD diagnosis in patients with dyspnea or other symptoms of COPD.2,3 A later diagnosis was associated with worse outcomes.
In the first study, researchers in Sweden identified patients older than 40 years who had received a new diagnosis of COPD between 2000 and 2014.2 They examined electronic health record data for 6 different “indicators” of COPD during the 5 years prior to date of diagnosis: pneumonia, other respiratory disease, oral steroids, antibiotics for respiratory infection, prescribed drugs for respiratory symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (if they had ≤ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3870), late diagnosis (n = 8827) was associated with
- a higher annual rate of exacerbations within the first 2 years after diagnosis (2.67 vs 1.41; hazard ratio [HR] = 1.89; 95% CI, 1.83-1.96; P < .0001; number of early diagnoses needed to prevent 1 exacerbation in 1 year = 79),
- shorter time to first exacerbation (HR = 1.61; 95% CI, 1.54-1.69; P < .0001), and
- higher direct health care costs (by €1500 per year; no P value given).
Mortality was not different between the groups (HR = 1.04; 95% CI, 0.98-1.11; P = .18).
The second investigation was a similarly designed retrospective observational cohort study using a large UK database.3 Researchers enrolled patients who were at least 40 years old and received a new diagnosis of COPD between 2011 and 2014.
Continue to: Researchers examined electronic...
Researchers examined electronic health record data in the 5 years prior to diagnosis for 7 possible indicators of early COPD: pneumonia, respiratory disease other than pneumonia, chest radiograph, prescription of oral steroids, prescription of antibiotics for lung infection, prescription to manage respiratory disease symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (≥ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3375), late diagnosis (n = 6783) was associated with a higher annual rate of exacerbations over 3-year follow-up (1.09 vs 0.57; adjusted HR = 1.68; 95% CI, 1.59-1.79; P < .0001; or 1 additional exacerbation in 192 patients in 1 year), shorter mean time to first exacerbation (HR = 1.46; 95% CI: 1.38-1.55; P < .0001), and a higher risk of hospitalization within 3 years (rate ratio = 1.18; 95% CI, 1.08-1.28; P = .0001). The researchers did not evaluate for mortality.
Importantly, patients in the late COPD diagnosis group in both trials had higher rates of other severe illnesses that cause dyspnea, including cardiovascular disease and other pulmonary diseases. As a result, dyspnea of other etiologies may have contributed to both the later diagnoses and the poorer clinical outcomes of the late-diagnosis group. Both studies had a high risk of lead-time bias.
Recommendations from others
In 2016, the USPSTF gave a “D” rating (moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits) to screening asymptomatic adults without respiratory symptoms for COPD.4 Likewise, the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report did not recommend routine screening with spirometry but did advocate trying to make an accurate diagnosis using spirometry in patients with risk factors for COPD and chronic, progressive symptoms.5
Editor’s takeaway
Reasonably good evidence failed to find a benefit from an early COPD diagnosis. Even smoking cessation rates were not improved. Without better disease-modifying treatments, spirometry—the gold standard for confirming a COPD diagnosis—should not be used for screening asymptomatic patients.
1. Guirguis-Blake JM, Senger CA, Webber EM, et al. Screening for chronic obstructive pulmonary disease: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:1378-1393. doi:10.1001/jama.2016.2654
2. Larsson K, Janson C, Ställberg B, et al. Impact of COPD diagnosis timing on clinical and economic outcomes: the ARCTIC observational cohort study. Int J Chron Obstruct Pulmon Dis. 2019;14:995-1008. doi: 10.2147/COPD.S195382
3. Kostikas K, Price D, Gutzwiller FS, et al. Clinical impact and healthcare resource utilization associated with early versus late COPD diagnosis in patients from UK CPRD database. Int J Chron Obstruct Pulmon Dis. 2020;15:1729-1738. doi: 10.2147/COPD.S255414
4. US Preventive Services Task Force; Siu AL, Bibbins-Domingo K, Grossman DC, et al. Screening for chronic obstructive pulmonary disease: US Preventive Services Task Force recommendation statement. JAMA. 2016;315:1372-1377. doi: 10.1001/jama.2016.2638
5. Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD executive summary. Am J Respir Crit Care Med. 2017;195:557-582. doi: 10.1164/rccm.201701-0218PP
EVIDENCE SUMMARY
Early Dx didn’t improve smoking cessation rates or treatment outcomes
A 2016 evidence report and systematic review for the US Preventive Services Task Force (USPSTF) identified no studies directly comparing the effectiveness of COPD screening on patient outcomes, so the authors looked first at studies on the outcomes of screening, followed by studies exploring the effects of early treatment.1
The authors identified 5 fair-quality RCTs (N = 1694) addressing the effect of screening asymptomatic patients for COPD with spirometry on the outcome of smoking cessation. One trial (n = 561) found better 12-month smoking cessation rates in patients who underwent spirometry screening and were given their “lung age” (13.6% vs 6.4% not given a lung age; P < .005; number needed to treat [NNT] = 14). However, a similar study (n = 542) published a year later found no significant difference in quit rates with or without “lung age” discussions (10.9% vs 13%, respectively; P not significant). In the other 3 studies, screening produced no significant effect on smoking cessation rates.1
As for possible early treatment benefits, the review authors identified only 1 RCT (n = 1175) that included any patients with mild COPD (defined as COPD with a forced expiratory volume in 1 second [FEV1] ≥ 80% of predicted normal value). It assessed treatment with inhaled corticosteroids (ICS) in patients with mild COPD who continued to smoke. The trial did not record symptoms (if any) at intake. ICS therapy reduced the frequency of COPD exacerbations (relative risk = 0.63; 95% CI, 0.47-0.85), although patients with milder COPD benefitted little in absolute terms (by 0.02 exacerbations/year).1 The review authors further noted that data were insufficient to make definitive statements about the effect of ICS on dyspnea or health-related quality of life.
But later diagnosis is associated with poorer outcomes
Two recent, large retrospective observational cohort studies, however, have examined the impact of an early vs late COPD diagnosis in patients with dyspnea or other symptoms of COPD.2,3 A later diagnosis was associated with worse outcomes.
In the first study, researchers in Sweden identified patients older than 40 years who had received a new diagnosis of COPD between 2000 and 2014.2 They examined electronic health record data for 6 different “indicators” of COPD during the 5 years prior to date of diagnosis: pneumonia, other respiratory disease, oral steroids, antibiotics for respiratory infection, prescribed drugs for respiratory symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (if they had ≤ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3870), late diagnosis (n = 8827) was associated with
- a higher annual rate of exacerbations within the first 2 years after diagnosis (2.67 vs 1.41; hazard ratio [HR] = 1.89; 95% CI, 1.83-1.96; P < .0001; number of early diagnoses needed to prevent 1 exacerbation in 1 year = 79),
- shorter time to first exacerbation (HR = 1.61; 95% CI, 1.54-1.69; P < .0001), and
- higher direct health care costs (by €1500 per year; no P value given).
Mortality was not different between the groups (HR = 1.04; 95% CI, 0.98-1.11; P = .18).
The second investigation was a similarly designed retrospective observational cohort study using a large UK database.3 Researchers enrolled patients who were at least 40 years old and received a new diagnosis of COPD between 2011 and 2014.
Continue to: Researchers examined electronic...
Researchers examined electronic health record data in the 5 years prior to diagnosis for 7 possible indicators of early COPD: pneumonia, respiratory disease other than pneumonia, chest radiograph, prescription of oral steroids, prescription of antibiotics for lung infection, prescription to manage respiratory disease symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (≥ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3375), late diagnosis (n = 6783) was associated with a higher annual rate of exacerbations over 3-year follow-up (1.09 vs 0.57; adjusted HR = 1.68; 95% CI, 1.59-1.79; P < .0001; or 1 additional exacerbation in 192 patients in 1 year), shorter mean time to first exacerbation (HR = 1.46; 95% CI: 1.38-1.55; P < .0001), and a higher risk of hospitalization within 3 years (rate ratio = 1.18; 95% CI, 1.08-1.28; P = .0001). The researchers did not evaluate for mortality.
Importantly, patients in the late COPD diagnosis group in both trials had higher rates of other severe illnesses that cause dyspnea, including cardiovascular disease and other pulmonary diseases. As a result, dyspnea of other etiologies may have contributed to both the later diagnoses and the poorer clinical outcomes of the late-diagnosis group. Both studies had a high risk of lead-time bias.
Recommendations from others
In 2016, the USPSTF gave a “D” rating (moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits) to screening asymptomatic adults without respiratory symptoms for COPD.4 Likewise, the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report did not recommend routine screening with spirometry but did advocate trying to make an accurate diagnosis using spirometry in patients with risk factors for COPD and chronic, progressive symptoms.5
Editor’s takeaway
Reasonably good evidence failed to find a benefit from an early COPD diagnosis. Even smoking cessation rates were not improved. Without better disease-modifying treatments, spirometry—the gold standard for confirming a COPD diagnosis—should not be used for screening asymptomatic patients.
EVIDENCE SUMMARY
Early Dx didn’t improve smoking cessation rates or treatment outcomes
A 2016 evidence report and systematic review for the US Preventive Services Task Force (USPSTF) identified no studies directly comparing the effectiveness of COPD screening on patient outcomes, so the authors looked first at studies on the outcomes of screening, followed by studies exploring the effects of early treatment.1
The authors identified 5 fair-quality RCTs (N = 1694) addressing the effect of screening asymptomatic patients for COPD with spirometry on the outcome of smoking cessation. One trial (n = 561) found better 12-month smoking cessation rates in patients who underwent spirometry screening and were given their “lung age” (13.6% vs 6.4% not given a lung age; P < .005; number needed to treat [NNT] = 14). However, a similar study (n = 542) published a year later found no significant difference in quit rates with or without “lung age” discussions (10.9% vs 13%, respectively; P not significant). In the other 3 studies, screening produced no significant effect on smoking cessation rates.1
As for possible early treatment benefits, the review authors identified only 1 RCT (n = 1175) that included any patients with mild COPD (defined as COPD with a forced expiratory volume in 1 second [FEV1] ≥ 80% of predicted normal value). It assessed treatment with inhaled corticosteroids (ICS) in patients with mild COPD who continued to smoke. The trial did not record symptoms (if any) at intake. ICS therapy reduced the frequency of COPD exacerbations (relative risk = 0.63; 95% CI, 0.47-0.85), although patients with milder COPD benefitted little in absolute terms (by 0.02 exacerbations/year).1 The review authors further noted that data were insufficient to make definitive statements about the effect of ICS on dyspnea or health-related quality of life.
But later diagnosis is associated with poorer outcomes
Two recent, large retrospective observational cohort studies, however, have examined the impact of an early vs late COPD diagnosis in patients with dyspnea or other symptoms of COPD.2,3 A later diagnosis was associated with worse outcomes.
In the first study, researchers in Sweden identified patients older than 40 years who had received a new diagnosis of COPD between 2000 and 2014.2 They examined electronic health record data for 6 different “indicators” of COPD during the 5 years prior to date of diagnosis: pneumonia, other respiratory disease, oral steroids, antibiotics for respiratory infection, prescribed drugs for respiratory symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (if they had ≤ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3870), late diagnosis (n = 8827) was associated with
- a higher annual rate of exacerbations within the first 2 years after diagnosis (2.67 vs 1.41; hazard ratio [HR] = 1.89; 95% CI, 1.83-1.96; P < .0001; number of early diagnoses needed to prevent 1 exacerbation in 1 year = 79),
- shorter time to first exacerbation (HR = 1.61; 95% CI, 1.54-1.69; P < .0001), and
- higher direct health care costs (by €1500 per year; no P value given).
Mortality was not different between the groups (HR = 1.04; 95% CI, 0.98-1.11; P = .18).
The second investigation was a similarly designed retrospective observational cohort study using a large UK database.3 Researchers enrolled patients who were at least 40 years old and received a new diagnosis of COPD between 2011 and 2014.
Continue to: Researchers examined electronic...
Researchers examined electronic health record data in the 5 years prior to diagnosis for 7 possible indicators of early COPD: pneumonia, respiratory disease other than pneumonia, chest radiograph, prescription of oral steroids, prescription of antibiotics for lung infection, prescription to manage respiratory disease symptoms, and lung function measurement. Researchers categorized patients as early diagnosis (≥ 2 indicators prior to diagnosis) or late diagnosis (≥ 3 indicators prior to diagnosis). Compared with early diagnosis (n = 3375), late diagnosis (n = 6783) was associated with a higher annual rate of exacerbations over 3-year follow-up (1.09 vs 0.57; adjusted HR = 1.68; 95% CI, 1.59-1.79; P < .0001; or 1 additional exacerbation in 192 patients in 1 year), shorter mean time to first exacerbation (HR = 1.46; 95% CI: 1.38-1.55; P < .0001), and a higher risk of hospitalization within 3 years (rate ratio = 1.18; 95% CI, 1.08-1.28; P = .0001). The researchers did not evaluate for mortality.
Importantly, patients in the late COPD diagnosis group in both trials had higher rates of other severe illnesses that cause dyspnea, including cardiovascular disease and other pulmonary diseases. As a result, dyspnea of other etiologies may have contributed to both the later diagnoses and the poorer clinical outcomes of the late-diagnosis group. Both studies had a high risk of lead-time bias.
Recommendations from others
In 2016, the USPSTF gave a “D” rating (moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits) to screening asymptomatic adults without respiratory symptoms for COPD.4 Likewise, the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report did not recommend routine screening with spirometry but did advocate trying to make an accurate diagnosis using spirometry in patients with risk factors for COPD and chronic, progressive symptoms.5
Editor’s takeaway
Reasonably good evidence failed to find a benefit from an early COPD diagnosis. Even smoking cessation rates were not improved. Without better disease-modifying treatments, spirometry—the gold standard for confirming a COPD diagnosis—should not be used for screening asymptomatic patients.
1. Guirguis-Blake JM, Senger CA, Webber EM, et al. Screening for chronic obstructive pulmonary disease: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:1378-1393. doi:10.1001/jama.2016.2654
2. Larsson K, Janson C, Ställberg B, et al. Impact of COPD diagnosis timing on clinical and economic outcomes: the ARCTIC observational cohort study. Int J Chron Obstruct Pulmon Dis. 2019;14:995-1008. doi: 10.2147/COPD.S195382
3. Kostikas K, Price D, Gutzwiller FS, et al. Clinical impact and healthcare resource utilization associated with early versus late COPD diagnosis in patients from UK CPRD database. Int J Chron Obstruct Pulmon Dis. 2020;15:1729-1738. doi: 10.2147/COPD.S255414
4. US Preventive Services Task Force; Siu AL, Bibbins-Domingo K, Grossman DC, et al. Screening for chronic obstructive pulmonary disease: US Preventive Services Task Force recommendation statement. JAMA. 2016;315:1372-1377. doi: 10.1001/jama.2016.2638
5. Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD executive summary. Am J Respir Crit Care Med. 2017;195:557-582. doi: 10.1164/rccm.201701-0218PP
1. Guirguis-Blake JM, Senger CA, Webber EM, et al. Screening for chronic obstructive pulmonary disease: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:1378-1393. doi:10.1001/jama.2016.2654
2. Larsson K, Janson C, Ställberg B, et al. Impact of COPD diagnosis timing on clinical and economic outcomes: the ARCTIC observational cohort study. Int J Chron Obstruct Pulmon Dis. 2019;14:995-1008. doi: 10.2147/COPD.S195382
3. Kostikas K, Price D, Gutzwiller FS, et al. Clinical impact and healthcare resource utilization associated with early versus late COPD diagnosis in patients from UK CPRD database. Int J Chron Obstruct Pulmon Dis. 2020;15:1729-1738. doi: 10.2147/COPD.S255414
4. US Preventive Services Task Force; Siu AL, Bibbins-Domingo K, Grossman DC, et al. Screening for chronic obstructive pulmonary disease: US Preventive Services Task Force recommendation statement. JAMA. 2016;315:1372-1377. doi: 10.1001/jama.2016.2638
5. Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD executive summary. Am J Respir Crit Care Med. 2017;195:557-582. doi: 10.1164/rccm.201701-0218PP
EVIDENCE-BASED ANSWER:
It depends. A diagnosis of chronic obstructive pulmonary disease (COPD) made using screening spirometry in patients without symptoms does not change the course of the disease or alter smoking rates (strength of recommendation [SOR]: A, preponderance of evidence from multiple randomized controlled trials [RCTs]). However, once a patient develops symptoms of lung disease, a delayed diagnosis is associated with poorer outcomes (SOR: B, cohort studies). Active case finding (including the use of spirometry) is recommended for patients with risk factors for COPD who present with consistent symptoms (SOR: C, expert opinion).
New screening tool identifies asthma risk in toddlers
A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.
The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.
Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.
“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.
Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”
“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.
Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).
CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.
“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.
CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.
“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.
The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.
“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”
Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”
However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”
CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.
Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.
This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.
A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.
The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.
Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.
“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.
Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”
“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.
Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).
CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.
“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.
CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.
“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.
The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.
“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”
Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”
However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”
CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.
Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.
This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.
A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.
The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.
Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.
“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.
Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”
“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.
Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).
CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.
“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.
CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.
“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.
The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.
“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”
Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”
However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”
CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.
Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.
This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.
FROM JAMA NETWORK OPEN
FDA: Newborns protected by whooping cough vaccine
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
Is another COVID-19 booster really needed?
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Death of son reinforces flu vaccination message
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
Antifibrotic shows mixed results in RA-ILD
The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.
“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.
in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.
The study was published online in the Lancet Respiratory Medicine.
TRAIL1
The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.
Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.
“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.
Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).
Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.
In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.
“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.
Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.
Wrong endpoint?
In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.
Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.
Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.
The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.
“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.
in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.
The study was published online in the Lancet Respiratory Medicine.
TRAIL1
The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.
Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.
“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.
Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).
Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.
In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.
“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.
Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.
Wrong endpoint?
In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.
Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.
Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.
The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.
“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.
in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.
The study was published online in the Lancet Respiratory Medicine.
TRAIL1
The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.
Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.
“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.
Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).
Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.
In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.
“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.
Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.
Wrong endpoint?
In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.
Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.
Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.
FROM THE LANCET RESPIRATORY MEDICINE
Pulmonology Data Trends 2022
CHEST Physician presents the 2022 edition of Pulmonology Data Trends (click to view the digital edition). This special issue provides updates on hot topics in pulmonology through original infographics and visual storytelling.
Inside this issue:
- Comorbidities, Racial Disparities, and Geographic Differences in Asthma
Navitha Ramesh, MD, FCCP - Post-COVID-19 Effects
Viren Kaul, MD, FCCP, FACP - New Pathogens, COVID-19, and Antibiotic Resistance in the Field of Pneumonia
Marcos I. Restrepo, MD, MSc, PhD, FCCP - COPD Characteristics and Health Disparities
Muhammad Adrish, MD, MBA, FCCP - Reducing Tuberculosis Globally and the Impact of COVID-19
Patricio Escalante, MD, MSc, FCCP and Paige K. Marty, MD - New Treatment Pathways for Cystic Fibrosis
David Finklea, MD - Risk Assessment in Pulmonary Arterial Hypertension
Sandeep Sahay, MD, MSc, FCCP, ATSF - Rising Incidence of Bronchiectasis and Associated Burdens
Anne E. O'Donnell, MD, FCCP - ILD: Diagnostic Considerations and Socioeconomic Barriers
Daniel Dilling, MD, FCCP, FACP, FAST - Advances in Lung Cancer Diagnostics and Treatment
Eric S. Edell, MD, FCCP
CHEST Physician presents the 2022 edition of Pulmonology Data Trends (click to view the digital edition). This special issue provides updates on hot topics in pulmonology through original infographics and visual storytelling.
Inside this issue:
- Comorbidities, Racial Disparities, and Geographic Differences in Asthma
Navitha Ramesh, MD, FCCP - Post-COVID-19 Effects
Viren Kaul, MD, FCCP, FACP - New Pathogens, COVID-19, and Antibiotic Resistance in the Field of Pneumonia
Marcos I. Restrepo, MD, MSc, PhD, FCCP - COPD Characteristics and Health Disparities
Muhammad Adrish, MD, MBA, FCCP - Reducing Tuberculosis Globally and the Impact of COVID-19
Patricio Escalante, MD, MSc, FCCP and Paige K. Marty, MD - New Treatment Pathways for Cystic Fibrosis
David Finklea, MD - Risk Assessment in Pulmonary Arterial Hypertension
Sandeep Sahay, MD, MSc, FCCP, ATSF - Rising Incidence of Bronchiectasis and Associated Burdens
Anne E. O'Donnell, MD, FCCP - ILD: Diagnostic Considerations and Socioeconomic Barriers
Daniel Dilling, MD, FCCP, FACP, FAST - Advances in Lung Cancer Diagnostics and Treatment
Eric S. Edell, MD, FCCP
CHEST Physician presents the 2022 edition of Pulmonology Data Trends (click to view the digital edition). This special issue provides updates on hot topics in pulmonology through original infographics and visual storytelling.
Inside this issue:
- Comorbidities, Racial Disparities, and Geographic Differences in Asthma
Navitha Ramesh, MD, FCCP - Post-COVID-19 Effects
Viren Kaul, MD, FCCP, FACP - New Pathogens, COVID-19, and Antibiotic Resistance in the Field of Pneumonia
Marcos I. Restrepo, MD, MSc, PhD, FCCP - COPD Characteristics and Health Disparities
Muhammad Adrish, MD, MBA, FCCP - Reducing Tuberculosis Globally and the Impact of COVID-19
Patricio Escalante, MD, MSc, FCCP and Paige K. Marty, MD - New Treatment Pathways for Cystic Fibrosis
David Finklea, MD - Risk Assessment in Pulmonary Arterial Hypertension
Sandeep Sahay, MD, MSc, FCCP, ATSF - Rising Incidence of Bronchiectasis and Associated Burdens
Anne E. O'Donnell, MD, FCCP - ILD: Diagnostic Considerations and Socioeconomic Barriers
Daniel Dilling, MD, FCCP, FACP, FAST - Advances in Lung Cancer Diagnostics and Treatment
Eric S. Edell, MD, FCCP
Meet our newest genetically engineered frenemy, herpes
Herpes to the rescue
Let’s face it: When people hear the word “herpes,” their first thoughts are not positive. But what if herpes could be a hero?
Scientists have found a way to make a strain of herpes that kills cancer because, hey, it’s 2022, and anything is possible. Trials have been going well and this seems like a safe and effective way to fight cancer.
Viruses may be one of our oldest enemies, but it’s also been said that the enemy of my enemy is my friend. So why not make herpes the enemy of cancer, thereby turning it into our friend? The genetically modified herpes virus is injected directly into tumors, where it destroys cancer cells from within. But wait, there’s more! The patient’s immune system also senses the virus and springs into action against it and the cancer in which it is residing.
During the phase 1 trial, three of the nine patients saw tumor reduction and the therapy proved safe as well. Future trials will be able to more specifically target various cancer types and make the treatment better. For once, we are rooting for you, herpes.
A breath of not-so-fresh air
There’s nothing quite like that first real warm day of spring. You can finally open the windows and clear out the old stuffy air that’s been hanging around all winter long. It’s a ritual that’s now backed up with some science in the form of a new study. Turns out that there’s actually a fair amount of smog in the average home. That’s right, smog’s not just for the big city anymore.
As part of the HOMEChem project, a whole host of scientists gathered together under one roof in a typical suburban house and immediately started doing chores. Cooking, cleaning, the works. No, it wasn’t because they had trashed the place the night before. They had set up instrumentation all around the house to measure the chemical makeup of the air inside. A scientist’s idea of a wild party.
The results are perhaps not all that surprising, but interesting nonetheless. Your homemade smog certainly won’t kill you, but there’s both an increased amount and higher concentration of airborne toxins in indoor air, compared with outdoors. Benzene and formaldehyde were common, as were acrolein (a pulmonary toxicant emitted by lumber and burning fats) and isocyanic acid (which can react with proteins in the human body). The researchers noted that most of these chemicals can be removed with proper ventilation.
Although cleaning is certainly responsible for a fair share of the chemicals, cooking generally produced more toxic compounds, similar to what’s found in wildfire smoke. One of the researchers said this makes sense, since a wildfire can be considered an “extreme form of cooking.” Scientists may not know how to party, but their idea of a barbecue sounds … interesting. We’re looking forward to an upcoming study out of California: Can a 1-million acre wildfire adequately cook a ribeye steak?
We’re dying to try composting ... with humans, that is
We here at LOTME are not really fans of politicians, except as objects of ridicule. That is kind of fun. Whether we’re watching Fox News, listening to NPR, or reading Vladimir Putin’s fashion blog, one thing remains clear: If you want actual information, don’t ask a politician.
There are, of course, always exceptions, and we just found one: California state representative Cristina Garcia. Rep. Garcia sponsored a bill just signed into law by Gov. Gavin Newsom that legalizes the practice of human composting, the reduction of remains by “placing bodies in individual vessels and fostering gentle transformation into a nutrient-dense soil.”
Since we’ve written about this sort of thing before – Washington was the first state to legalize the process back in 2019 – we’re more interested now in what Rep. Garcia told NBC News while describing her motivation: “I’ve always wanted to be a tree. The idea of having my family sitting under my shade one day – that brings a lot of joy.” How great is that? Tree-hugging is just not enough. Be the tree.
California is the fifth state to provide its residents with the human composting option, the other three being Colorado, Oregon, and Vermont. The process “typically involves putting a body into a steel vessel, then covering it with organic materials like straw, wood chips and alfalfa. Microbes break down the corpse and the plant matter, transforming the various components into nutrient-rich soil in roughly 30 days,” Smithsonian Magazine explained.
We just happen to have some good news for Rep. Garcia about that wanting-to-be-a-tree business. She’s already pretty close. For more on that, we go to our correspondent from beyond the grave, Carl Sagan, who shares a thought about trees. And no, we couldn’t just write out his quote here. You have to hear it in Dr. Sagan’s own voice.
That’ll be one pandemic with extra distress. Hold the goals
When the COVID-19 pandemic first hit it put a lot of stuff on hold for everyone. Couldn’t eat inside at your favorite restaurant, attend that long-awaited concert, or travel out of the country. Those were all pretty bad, but it was the disruption of pursuing long-term goals that seemed to have the most effect on people’s mental health.
Investigators from the University of Waterloo (Ont.) looked at how putting such goals on hold affected people’s mental well-being. The study’s 226 participants were asked about their “COVID-frozen” goals and the degree to which they were able to actively pursue each goal and how committed they were to achieving it.
What they found was that the participants’ COVID-frozen goals were associated with feelings of psychological distress, such as anxiety, depressive symptoms, stress, and lowered life satisfaction. It was only when participants were able to disengage from goal rumination that well-being was impacted positively.
“Goal rumination is compulsive and can aggravate worries and frustrations while also taking away mental resources from other goals,” Candice Hubley, lead author and a PhD candidate in psychology, said in a written statement. So in short, you’re only stressing yourself out more about something that is far off in the distance when you could be focusing more on short-term, tangible goals instead.
Now, no one is saying to give up on your goals. Just take them one at a time. You’ll have better life satisfaction and your COVID-frozen goals will thaw out before you know it.
Herpes to the rescue
Let’s face it: When people hear the word “herpes,” their first thoughts are not positive. But what if herpes could be a hero?
Scientists have found a way to make a strain of herpes that kills cancer because, hey, it’s 2022, and anything is possible. Trials have been going well and this seems like a safe and effective way to fight cancer.
Viruses may be one of our oldest enemies, but it’s also been said that the enemy of my enemy is my friend. So why not make herpes the enemy of cancer, thereby turning it into our friend? The genetically modified herpes virus is injected directly into tumors, where it destroys cancer cells from within. But wait, there’s more! The patient’s immune system also senses the virus and springs into action against it and the cancer in which it is residing.
During the phase 1 trial, three of the nine patients saw tumor reduction and the therapy proved safe as well. Future trials will be able to more specifically target various cancer types and make the treatment better. For once, we are rooting for you, herpes.
A breath of not-so-fresh air
There’s nothing quite like that first real warm day of spring. You can finally open the windows and clear out the old stuffy air that’s been hanging around all winter long. It’s a ritual that’s now backed up with some science in the form of a new study. Turns out that there’s actually a fair amount of smog in the average home. That’s right, smog’s not just for the big city anymore.
As part of the HOMEChem project, a whole host of scientists gathered together under one roof in a typical suburban house and immediately started doing chores. Cooking, cleaning, the works. No, it wasn’t because they had trashed the place the night before. They had set up instrumentation all around the house to measure the chemical makeup of the air inside. A scientist’s idea of a wild party.
The results are perhaps not all that surprising, but interesting nonetheless. Your homemade smog certainly won’t kill you, but there’s both an increased amount and higher concentration of airborne toxins in indoor air, compared with outdoors. Benzene and formaldehyde were common, as were acrolein (a pulmonary toxicant emitted by lumber and burning fats) and isocyanic acid (which can react with proteins in the human body). The researchers noted that most of these chemicals can be removed with proper ventilation.
Although cleaning is certainly responsible for a fair share of the chemicals, cooking generally produced more toxic compounds, similar to what’s found in wildfire smoke. One of the researchers said this makes sense, since a wildfire can be considered an “extreme form of cooking.” Scientists may not know how to party, but their idea of a barbecue sounds … interesting. We’re looking forward to an upcoming study out of California: Can a 1-million acre wildfire adequately cook a ribeye steak?
We’re dying to try composting ... with humans, that is
We here at LOTME are not really fans of politicians, except as objects of ridicule. That is kind of fun. Whether we’re watching Fox News, listening to NPR, or reading Vladimir Putin’s fashion blog, one thing remains clear: If you want actual information, don’t ask a politician.
There are, of course, always exceptions, and we just found one: California state representative Cristina Garcia. Rep. Garcia sponsored a bill just signed into law by Gov. Gavin Newsom that legalizes the practice of human composting, the reduction of remains by “placing bodies in individual vessels and fostering gentle transformation into a nutrient-dense soil.”
Since we’ve written about this sort of thing before – Washington was the first state to legalize the process back in 2019 – we’re more interested now in what Rep. Garcia told NBC News while describing her motivation: “I’ve always wanted to be a tree. The idea of having my family sitting under my shade one day – that brings a lot of joy.” How great is that? Tree-hugging is just not enough. Be the tree.
California is the fifth state to provide its residents with the human composting option, the other three being Colorado, Oregon, and Vermont. The process “typically involves putting a body into a steel vessel, then covering it with organic materials like straw, wood chips and alfalfa. Microbes break down the corpse and the plant matter, transforming the various components into nutrient-rich soil in roughly 30 days,” Smithsonian Magazine explained.
We just happen to have some good news for Rep. Garcia about that wanting-to-be-a-tree business. She’s already pretty close. For more on that, we go to our correspondent from beyond the grave, Carl Sagan, who shares a thought about trees. And no, we couldn’t just write out his quote here. You have to hear it in Dr. Sagan’s own voice.
That’ll be one pandemic with extra distress. Hold the goals
When the COVID-19 pandemic first hit it put a lot of stuff on hold for everyone. Couldn’t eat inside at your favorite restaurant, attend that long-awaited concert, or travel out of the country. Those were all pretty bad, but it was the disruption of pursuing long-term goals that seemed to have the most effect on people’s mental health.
Investigators from the University of Waterloo (Ont.) looked at how putting such goals on hold affected people’s mental well-being. The study’s 226 participants were asked about their “COVID-frozen” goals and the degree to which they were able to actively pursue each goal and how committed they were to achieving it.
What they found was that the participants’ COVID-frozen goals were associated with feelings of psychological distress, such as anxiety, depressive symptoms, stress, and lowered life satisfaction. It was only when participants were able to disengage from goal rumination that well-being was impacted positively.
“Goal rumination is compulsive and can aggravate worries and frustrations while also taking away mental resources from other goals,” Candice Hubley, lead author and a PhD candidate in psychology, said in a written statement. So in short, you’re only stressing yourself out more about something that is far off in the distance when you could be focusing more on short-term, tangible goals instead.
Now, no one is saying to give up on your goals. Just take them one at a time. You’ll have better life satisfaction and your COVID-frozen goals will thaw out before you know it.
Herpes to the rescue
Let’s face it: When people hear the word “herpes,” their first thoughts are not positive. But what if herpes could be a hero?
Scientists have found a way to make a strain of herpes that kills cancer because, hey, it’s 2022, and anything is possible. Trials have been going well and this seems like a safe and effective way to fight cancer.
Viruses may be one of our oldest enemies, but it’s also been said that the enemy of my enemy is my friend. So why not make herpes the enemy of cancer, thereby turning it into our friend? The genetically modified herpes virus is injected directly into tumors, where it destroys cancer cells from within. But wait, there’s more! The patient’s immune system also senses the virus and springs into action against it and the cancer in which it is residing.
During the phase 1 trial, three of the nine patients saw tumor reduction and the therapy proved safe as well. Future trials will be able to more specifically target various cancer types and make the treatment better. For once, we are rooting for you, herpes.
A breath of not-so-fresh air
There’s nothing quite like that first real warm day of spring. You can finally open the windows and clear out the old stuffy air that’s been hanging around all winter long. It’s a ritual that’s now backed up with some science in the form of a new study. Turns out that there’s actually a fair amount of smog in the average home. That’s right, smog’s not just for the big city anymore.
As part of the HOMEChem project, a whole host of scientists gathered together under one roof in a typical suburban house and immediately started doing chores. Cooking, cleaning, the works. No, it wasn’t because they had trashed the place the night before. They had set up instrumentation all around the house to measure the chemical makeup of the air inside. A scientist’s idea of a wild party.
The results are perhaps not all that surprising, but interesting nonetheless. Your homemade smog certainly won’t kill you, but there’s both an increased amount and higher concentration of airborne toxins in indoor air, compared with outdoors. Benzene and formaldehyde were common, as were acrolein (a pulmonary toxicant emitted by lumber and burning fats) and isocyanic acid (which can react with proteins in the human body). The researchers noted that most of these chemicals can be removed with proper ventilation.
Although cleaning is certainly responsible for a fair share of the chemicals, cooking generally produced more toxic compounds, similar to what’s found in wildfire smoke. One of the researchers said this makes sense, since a wildfire can be considered an “extreme form of cooking.” Scientists may not know how to party, but their idea of a barbecue sounds … interesting. We’re looking forward to an upcoming study out of California: Can a 1-million acre wildfire adequately cook a ribeye steak?
We’re dying to try composting ... with humans, that is
We here at LOTME are not really fans of politicians, except as objects of ridicule. That is kind of fun. Whether we’re watching Fox News, listening to NPR, or reading Vladimir Putin’s fashion blog, one thing remains clear: If you want actual information, don’t ask a politician.
There are, of course, always exceptions, and we just found one: California state representative Cristina Garcia. Rep. Garcia sponsored a bill just signed into law by Gov. Gavin Newsom that legalizes the practice of human composting, the reduction of remains by “placing bodies in individual vessels and fostering gentle transformation into a nutrient-dense soil.”
Since we’ve written about this sort of thing before – Washington was the first state to legalize the process back in 2019 – we’re more interested now in what Rep. Garcia told NBC News while describing her motivation: “I’ve always wanted to be a tree. The idea of having my family sitting under my shade one day – that brings a lot of joy.” How great is that? Tree-hugging is just not enough. Be the tree.
California is the fifth state to provide its residents with the human composting option, the other three being Colorado, Oregon, and Vermont. The process “typically involves putting a body into a steel vessel, then covering it with organic materials like straw, wood chips and alfalfa. Microbes break down the corpse and the plant matter, transforming the various components into nutrient-rich soil in roughly 30 days,” Smithsonian Magazine explained.
We just happen to have some good news for Rep. Garcia about that wanting-to-be-a-tree business. She’s already pretty close. For more on that, we go to our correspondent from beyond the grave, Carl Sagan, who shares a thought about trees. And no, we couldn’t just write out his quote here. You have to hear it in Dr. Sagan’s own voice.
That’ll be one pandemic with extra distress. Hold the goals
When the COVID-19 pandemic first hit it put a lot of stuff on hold for everyone. Couldn’t eat inside at your favorite restaurant, attend that long-awaited concert, or travel out of the country. Those were all pretty bad, but it was the disruption of pursuing long-term goals that seemed to have the most effect on people’s mental health.
Investigators from the University of Waterloo (Ont.) looked at how putting such goals on hold affected people’s mental well-being. The study’s 226 participants were asked about their “COVID-frozen” goals and the degree to which they were able to actively pursue each goal and how committed they were to achieving it.
What they found was that the participants’ COVID-frozen goals were associated with feelings of psychological distress, such as anxiety, depressive symptoms, stress, and lowered life satisfaction. It was only when participants were able to disengage from goal rumination that well-being was impacted positively.
“Goal rumination is compulsive and can aggravate worries and frustrations while also taking away mental resources from other goals,” Candice Hubley, lead author and a PhD candidate in psychology, said in a written statement. So in short, you’re only stressing yourself out more about something that is far off in the distance when you could be focusing more on short-term, tangible goals instead.
Now, no one is saying to give up on your goals. Just take them one at a time. You’ll have better life satisfaction and your COVID-frozen goals will thaw out before you know it.