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Making invisible problems visible
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.
Fighting for fresh air: RSV’s connection to environmental pollution
Diffuse Lung Disease and Lung Transplant Network
Occupational and Environmental Health Section
Poor air quality has numerous health hazards for patients with chronic lung disease. Now mounting evidence from pediatric studies suggests a concerning link between air pollution and viral infections, specifically respiratory syncytial virus (RSV).
Multiple studies have shown increased incidence and severity of disease in children with exposure to air pollutants such as particulate matter and nitrogen dioxide.1,2,3 Researchers speculate that these pollutants potentiate viral entry to airway epithelium, increase viral load, and dysregulate the immune response.4 Air pollution, increasingly worsened by climate change, is also associated with acute respiratory infections in adults, though adult research remains sparse.5
The adoption of viral testing during the pandemic has revealed a previously under-recognized prevalence of RSV in adults.
RSV accounts for an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among elderly adults. This newfound awareness coincides with the exciting development of a new RSV vaccine that has shown around 85% efficacy at preventing symptomatic RSV infection in the first year, and new data suggest benefits persisting even into the second year after vaccination.6 With an estimated 60 million adults at high risk for RSV in the US, RSV prevention has become an increasingly important aspect of respiratory care.
While more research is needed to definitively quantify the link between air pollution and RSV in adults, the existing data offer valuable insights for all pulmonologists. These findings suggest a benefit in counseling patients with chronic lung conditions on taking steps to mitigate exposure to air pollutants, either through avoidance of outdoor activities or mask-wearing when air quality levels exceed healthy ranges, as well as promoting RSV vaccination for patients who are at risk.7
References
1. Milani GP, Cafora M, Favero C, et al. PM2.5, PM10 and bronchiolitis severity: a cohort study. Pediatr Allergy Immunol. 2022;33(10). https://doi.org/10.1111/pai.13853
2. Wrotek A, Badyda A, Czechowski PO, Owczarek T, Dąbrowiecki P, Jackowska T. Air pollutants’ concentrations are associated with increased number of RSV hospitalizations in Polish children. J Clin Med. 2021;10(15):3224. https://doi.org/10.3390/jcm10153224
3. Horne BD, Joy EA, Hofmann MG, et al. Short-term elevation of fine particulate matter air pollution and acute lower respiratory infection. Am J Respir Crit Care Med. 2018;198(6):759-766. https://doi.org/10.1164/rccm.201709-1883oc
4. Wrotek A, Jackowska T. Molecular mechanisms of RSV and air pollution interaction: a scoping review. Int J Mol Sci. 2022;23(20):12704. https://doi.org/10.3390/ijms232012704
5. Kirwa K, Eckert CM, Vedal S, Hajat A, Kaufman JD. Ambient air pollution and risk of respiratory infection among adults: evidence from the multiethnic study of atherosclerosis (MESA). BMJ Open Respir Res. 2021;8(1). https://doi.org/10.1136/bmjresp-2020-000866
6. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801. http://dx.doi.org/10.15585/mmwr.mm7229a4
7. Kodros JK, O’Dell K, Samet JM, L’Orange C, Pierce JR, Volckens J. Quantifying the health benefits of face masks and respirators to mitigate exposure to severe air pollution. GeoHealth. 2021;5(9). https://doi.org/10.1029/2021gh000482
Diffuse Lung Disease and Lung Transplant Network
Occupational and Environmental Health Section
Poor air quality has numerous health hazards for patients with chronic lung disease. Now mounting evidence from pediatric studies suggests a concerning link between air pollution and viral infections, specifically respiratory syncytial virus (RSV).
Multiple studies have shown increased incidence and severity of disease in children with exposure to air pollutants such as particulate matter and nitrogen dioxide.1,2,3 Researchers speculate that these pollutants potentiate viral entry to airway epithelium, increase viral load, and dysregulate the immune response.4 Air pollution, increasingly worsened by climate change, is also associated with acute respiratory infections in adults, though adult research remains sparse.5
The adoption of viral testing during the pandemic has revealed a previously under-recognized prevalence of RSV in adults.
RSV accounts for an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among elderly adults. This newfound awareness coincides with the exciting development of a new RSV vaccine that has shown around 85% efficacy at preventing symptomatic RSV infection in the first year, and new data suggest benefits persisting even into the second year after vaccination.6 With an estimated 60 million adults at high risk for RSV in the US, RSV prevention has become an increasingly important aspect of respiratory care.
While more research is needed to definitively quantify the link between air pollution and RSV in adults, the existing data offer valuable insights for all pulmonologists. These findings suggest a benefit in counseling patients with chronic lung conditions on taking steps to mitigate exposure to air pollutants, either through avoidance of outdoor activities or mask-wearing when air quality levels exceed healthy ranges, as well as promoting RSV vaccination for patients who are at risk.7
References
1. Milani GP, Cafora M, Favero C, et al. PM2.5, PM10 and bronchiolitis severity: a cohort study. Pediatr Allergy Immunol. 2022;33(10). https://doi.org/10.1111/pai.13853
2. Wrotek A, Badyda A, Czechowski PO, Owczarek T, Dąbrowiecki P, Jackowska T. Air pollutants’ concentrations are associated with increased number of RSV hospitalizations in Polish children. J Clin Med. 2021;10(15):3224. https://doi.org/10.3390/jcm10153224
3. Horne BD, Joy EA, Hofmann MG, et al. Short-term elevation of fine particulate matter air pollution and acute lower respiratory infection. Am J Respir Crit Care Med. 2018;198(6):759-766. https://doi.org/10.1164/rccm.201709-1883oc
4. Wrotek A, Jackowska T. Molecular mechanisms of RSV and air pollution interaction: a scoping review. Int J Mol Sci. 2022;23(20):12704. https://doi.org/10.3390/ijms232012704
5. Kirwa K, Eckert CM, Vedal S, Hajat A, Kaufman JD. Ambient air pollution and risk of respiratory infection among adults: evidence from the multiethnic study of atherosclerosis (MESA). BMJ Open Respir Res. 2021;8(1). https://doi.org/10.1136/bmjresp-2020-000866
6. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801. http://dx.doi.org/10.15585/mmwr.mm7229a4
7. Kodros JK, O’Dell K, Samet JM, L’Orange C, Pierce JR, Volckens J. Quantifying the health benefits of face masks and respirators to mitigate exposure to severe air pollution. GeoHealth. 2021;5(9). https://doi.org/10.1029/2021gh000482
Diffuse Lung Disease and Lung Transplant Network
Occupational and Environmental Health Section
Poor air quality has numerous health hazards for patients with chronic lung disease. Now mounting evidence from pediatric studies suggests a concerning link between air pollution and viral infections, specifically respiratory syncytial virus (RSV).
Multiple studies have shown increased incidence and severity of disease in children with exposure to air pollutants such as particulate matter and nitrogen dioxide.1,2,3 Researchers speculate that these pollutants potentiate viral entry to airway epithelium, increase viral load, and dysregulate the immune response.4 Air pollution, increasingly worsened by climate change, is also associated with acute respiratory infections in adults, though adult research remains sparse.5
The adoption of viral testing during the pandemic has revealed a previously under-recognized prevalence of RSV in adults.
RSV accounts for an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among elderly adults. This newfound awareness coincides with the exciting development of a new RSV vaccine that has shown around 85% efficacy at preventing symptomatic RSV infection in the first year, and new data suggest benefits persisting even into the second year after vaccination.6 With an estimated 60 million adults at high risk for RSV in the US, RSV prevention has become an increasingly important aspect of respiratory care.
While more research is needed to definitively quantify the link between air pollution and RSV in adults, the existing data offer valuable insights for all pulmonologists. These findings suggest a benefit in counseling patients with chronic lung conditions on taking steps to mitigate exposure to air pollutants, either through avoidance of outdoor activities or mask-wearing when air quality levels exceed healthy ranges, as well as promoting RSV vaccination for patients who are at risk.7
References
1. Milani GP, Cafora M, Favero C, et al. PM2.5, PM10 and bronchiolitis severity: a cohort study. Pediatr Allergy Immunol. 2022;33(10). https://doi.org/10.1111/pai.13853
2. Wrotek A, Badyda A, Czechowski PO, Owczarek T, Dąbrowiecki P, Jackowska T. Air pollutants’ concentrations are associated with increased number of RSV hospitalizations in Polish children. J Clin Med. 2021;10(15):3224. https://doi.org/10.3390/jcm10153224
3. Horne BD, Joy EA, Hofmann MG, et al. Short-term elevation of fine particulate matter air pollution and acute lower respiratory infection. Am J Respir Crit Care Med. 2018;198(6):759-766. https://doi.org/10.1164/rccm.201709-1883oc
4. Wrotek A, Jackowska T. Molecular mechanisms of RSV and air pollution interaction: a scoping review. Int J Mol Sci. 2022;23(20):12704. https://doi.org/10.3390/ijms232012704
5. Kirwa K, Eckert CM, Vedal S, Hajat A, Kaufman JD. Ambient air pollution and risk of respiratory infection among adults: evidence from the multiethnic study of atherosclerosis (MESA). BMJ Open Respir Res. 2021;8(1). https://doi.org/10.1136/bmjresp-2020-000866
6. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801. http://dx.doi.org/10.15585/mmwr.mm7229a4
7. Kodros JK, O’Dell K, Samet JM, L’Orange C, Pierce JR, Volckens J. Quantifying the health benefits of face masks and respirators to mitigate exposure to severe air pollution. GeoHealth. 2021;5(9). https://doi.org/10.1029/2021gh000482
A word of caution on e-cigarettes: Retracted paper
Editor’s note: On March 29, 2024, the authors of the study, “Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking: A Randomized Clinical Trial,” published in JAMA Internal Medicine, issued a formal retraction of their article. The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
An article in the April issue of the CHEST Physician publication headlined, “E-cigarettes beat nicotine gum for smoking cessation,” was based on an article in JAMA Internal Medicine by Liu Z and colleagues which was subsequently retracted by the author due to coding errors and discrepancies in calculations that cast doubt on the accuracy and reliability of the reported findings.
One should be cautious in evaluating claims of the benefits of electronic cigarettes (e-cigarettes). e-Cigarettes are a highly addictive and largely unregulated product. The fine print in previous clinical trials of e-cigarettes shows greater rates of stopping nicotine products—including e-cigarettes—in the groups assigned to recommendation for nicotine replacement therapy. e-Cigarettes have substantial acute and chronic harms.
Although much of the research to date is from animal models, there is a growing body of evidence in humans that validates the findings from the animal models. In laboratory animal models, e-cigarettes impair airway defenses, contribute to epithelial dysfunction, lead to apoptosis of airway cells, cause emphysematous changes, and lead to increased cancer rates.
Adverse effects on cardiovascular health have also been demonstrated. There is evidence of genotoxicity from e-cigarette exposure, with increased rates of DNA damage and decreased rates of DNA repair. Carcinogenic substances are present in e-cigarettes, and we may not see the carcinogenic effects in humans for several years or even decades. Commonly used flavoring chemicals have substantial pulmonary toxicity. There is evidence that the dual use of e-cigarettes and combustible tobacco can be more harmful than the use of combustible tobacco alone, as the person who smokes is now exposed to additional toxins unique to the e-cigarette.
E-cigarettes can cause severe acute lung disease; 14% of the severe e-cigarette or vaping product use-associated lung injury (EVALI) cases reported use of only nicotine-containing e-cigarette products. There are reports of people who used e-cigarettes who required lung transplant due to complications of their e-cigarette use.
The tobacco industry has a long history of “harm reduction” products that were anything but—from filter cigarettes (the “advanced” Kent Micronite filter contained asbestos) to the so-called low tar and nicotine cigarettes (which were no less harmful). There is a long history of physicians endorsing these products as “must be better.” The growing evidence that e-cigarettes carry distinct health risks of their own should prompt us to consider a broader picture beyond just comparing them with traditional cigarettes to assess their impact on health.
Physicians treating tobacco dependence should recommend US Food and Drug Administration-approved medications for pharmacotherapy. These have a robust evidence base documenting that they help people who smoke to break free of nicotine addiction. The goal of tobacco dependence treatment should be stopping ALL harmful tobacco/nicotine products—including e-cigarettes—not simply changing from one harmful product to another.
References
Liu Z. Notice of retraction: Lin HX et al. Efficacy of electronic cigarettes vs varenicline and nicotine chewing gum as an aid to stop smoking: a randomized clinical trial. JAMA Intern Med. 2024;184(3):291-299. JAMA Intern Med. Preprint. Posted online March 29, 2024. PMID: 38551593. doi: 10.1001/jamainternmed.2024.1125
Farber HJ, Conrado Pacheco Gallego M, Galiatsatos P, Folan P, Lamphere T, Pakhale S. Harms of electronic cigarettes: what the healthcare provider needs to know. Ann Am Thorac Soc. 2021;18(4):567-572. PMID: 33284731. doi: 10.1513/AnnalsATS.202009-1113CME
Proctor RN. Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition. University of California Press; 2011.
Auer R, Schoeni A, Humair JP, et al. Electronic nicotine-delivery systems for smoking cessation. N Engl J Med. 2024;390(7):601-610. PMID: 38354139. doi: 10.1056/NEJMoa2308815
Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380(7):629-637. Preprint. Posted online January 30, 2019. PMID: 30699054. doi: 10.1056/NEJMoa1808779
Editor’s note: On March 29, 2024, the authors of the study, “Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking: A Randomized Clinical Trial,” published in JAMA Internal Medicine, issued a formal retraction of their article. The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
An article in the April issue of the CHEST Physician publication headlined, “E-cigarettes beat nicotine gum for smoking cessation,” was based on an article in JAMA Internal Medicine by Liu Z and colleagues which was subsequently retracted by the author due to coding errors and discrepancies in calculations that cast doubt on the accuracy and reliability of the reported findings.
One should be cautious in evaluating claims of the benefits of electronic cigarettes (e-cigarettes). e-Cigarettes are a highly addictive and largely unregulated product. The fine print in previous clinical trials of e-cigarettes shows greater rates of stopping nicotine products—including e-cigarettes—in the groups assigned to recommendation for nicotine replacement therapy. e-Cigarettes have substantial acute and chronic harms.
Although much of the research to date is from animal models, there is a growing body of evidence in humans that validates the findings from the animal models. In laboratory animal models, e-cigarettes impair airway defenses, contribute to epithelial dysfunction, lead to apoptosis of airway cells, cause emphysematous changes, and lead to increased cancer rates.
Adverse effects on cardiovascular health have also been demonstrated. There is evidence of genotoxicity from e-cigarette exposure, with increased rates of DNA damage and decreased rates of DNA repair. Carcinogenic substances are present in e-cigarettes, and we may not see the carcinogenic effects in humans for several years or even decades. Commonly used flavoring chemicals have substantial pulmonary toxicity. There is evidence that the dual use of e-cigarettes and combustible tobacco can be more harmful than the use of combustible tobacco alone, as the person who smokes is now exposed to additional toxins unique to the e-cigarette.
E-cigarettes can cause severe acute lung disease; 14% of the severe e-cigarette or vaping product use-associated lung injury (EVALI) cases reported use of only nicotine-containing e-cigarette products. There are reports of people who used e-cigarettes who required lung transplant due to complications of their e-cigarette use.
The tobacco industry has a long history of “harm reduction” products that were anything but—from filter cigarettes (the “advanced” Kent Micronite filter contained asbestos) to the so-called low tar and nicotine cigarettes (which were no less harmful). There is a long history of physicians endorsing these products as “must be better.” The growing evidence that e-cigarettes carry distinct health risks of their own should prompt us to consider a broader picture beyond just comparing them with traditional cigarettes to assess their impact on health.
Physicians treating tobacco dependence should recommend US Food and Drug Administration-approved medications for pharmacotherapy. These have a robust evidence base documenting that they help people who smoke to break free of nicotine addiction. The goal of tobacco dependence treatment should be stopping ALL harmful tobacco/nicotine products—including e-cigarettes—not simply changing from one harmful product to another.
References
Liu Z. Notice of retraction: Lin HX et al. Efficacy of electronic cigarettes vs varenicline and nicotine chewing gum as an aid to stop smoking: a randomized clinical trial. JAMA Intern Med. 2024;184(3):291-299. JAMA Intern Med. Preprint. Posted online March 29, 2024. PMID: 38551593. doi: 10.1001/jamainternmed.2024.1125
Farber HJ, Conrado Pacheco Gallego M, Galiatsatos P, Folan P, Lamphere T, Pakhale S. Harms of electronic cigarettes: what the healthcare provider needs to know. Ann Am Thorac Soc. 2021;18(4):567-572. PMID: 33284731. doi: 10.1513/AnnalsATS.202009-1113CME
Proctor RN. Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition. University of California Press; 2011.
Auer R, Schoeni A, Humair JP, et al. Electronic nicotine-delivery systems for smoking cessation. N Engl J Med. 2024;390(7):601-610. PMID: 38354139. doi: 10.1056/NEJMoa2308815
Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380(7):629-637. Preprint. Posted online January 30, 2019. PMID: 30699054. doi: 10.1056/NEJMoa1808779
Editor’s note: On March 29, 2024, the authors of the study, “Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking: A Randomized Clinical Trial,” published in JAMA Internal Medicine, issued a formal retraction of their article. The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
An article in the April issue of the CHEST Physician publication headlined, “E-cigarettes beat nicotine gum for smoking cessation,” was based on an article in JAMA Internal Medicine by Liu Z and colleagues which was subsequently retracted by the author due to coding errors and discrepancies in calculations that cast doubt on the accuracy and reliability of the reported findings.
One should be cautious in evaluating claims of the benefits of electronic cigarettes (e-cigarettes). e-Cigarettes are a highly addictive and largely unregulated product. The fine print in previous clinical trials of e-cigarettes shows greater rates of stopping nicotine products—including e-cigarettes—in the groups assigned to recommendation for nicotine replacement therapy. e-Cigarettes have substantial acute and chronic harms.
Although much of the research to date is from animal models, there is a growing body of evidence in humans that validates the findings from the animal models. In laboratory animal models, e-cigarettes impair airway defenses, contribute to epithelial dysfunction, lead to apoptosis of airway cells, cause emphysematous changes, and lead to increased cancer rates.
Adverse effects on cardiovascular health have also been demonstrated. There is evidence of genotoxicity from e-cigarette exposure, with increased rates of DNA damage and decreased rates of DNA repair. Carcinogenic substances are present in e-cigarettes, and we may not see the carcinogenic effects in humans for several years or even decades. Commonly used flavoring chemicals have substantial pulmonary toxicity. There is evidence that the dual use of e-cigarettes and combustible tobacco can be more harmful than the use of combustible tobacco alone, as the person who smokes is now exposed to additional toxins unique to the e-cigarette.
E-cigarettes can cause severe acute lung disease; 14% of the severe e-cigarette or vaping product use-associated lung injury (EVALI) cases reported use of only nicotine-containing e-cigarette products. There are reports of people who used e-cigarettes who required lung transplant due to complications of their e-cigarette use.
The tobacco industry has a long history of “harm reduction” products that were anything but—from filter cigarettes (the “advanced” Kent Micronite filter contained asbestos) to the so-called low tar and nicotine cigarettes (which were no less harmful). There is a long history of physicians endorsing these products as “must be better.” The growing evidence that e-cigarettes carry distinct health risks of their own should prompt us to consider a broader picture beyond just comparing them with traditional cigarettes to assess their impact on health.
Physicians treating tobacco dependence should recommend US Food and Drug Administration-approved medications for pharmacotherapy. These have a robust evidence base documenting that they help people who smoke to break free of nicotine addiction. The goal of tobacco dependence treatment should be stopping ALL harmful tobacco/nicotine products—including e-cigarettes—not simply changing from one harmful product to another.
References
Liu Z. Notice of retraction: Lin HX et al. Efficacy of electronic cigarettes vs varenicline and nicotine chewing gum as an aid to stop smoking: a randomized clinical trial. JAMA Intern Med. 2024;184(3):291-299. JAMA Intern Med. Preprint. Posted online March 29, 2024. PMID: 38551593. doi: 10.1001/jamainternmed.2024.1125
Farber HJ, Conrado Pacheco Gallego M, Galiatsatos P, Folan P, Lamphere T, Pakhale S. Harms of electronic cigarettes: what the healthcare provider needs to know. Ann Am Thorac Soc. 2021;18(4):567-572. PMID: 33284731. doi: 10.1513/AnnalsATS.202009-1113CME
Proctor RN. Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition. University of California Press; 2011.
Auer R, Schoeni A, Humair JP, et al. Electronic nicotine-delivery systems for smoking cessation. N Engl J Med. 2024;390(7):601-610. PMID: 38354139. doi: 10.1056/NEJMoa2308815
Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380(7):629-637. Preprint. Posted online January 30, 2019. PMID: 30699054. doi: 10.1056/NEJMoa1808779
Fellow to use diversity scholar mentorship to strengthen care in pediatric-to-adult transitions
During residency training at the Rush University Medical Center in Internal Medicine and Pediatrics, Esha Kapania, MD, quickly became interested in the pulmonary pathologies that span the life of a patient, beginning in childhood and lasting into adulthood.
Now in her first year of fellowship at the University of Louisville and as the recipient of the 2024 Medical Educator Scholar Diversity Fellowship from CHEST and the Association of Pulmonary and Critical Care Medicine Program Directors (APCCMPD), Dr. Kapania will utilize the support of the program to explore this space.
“Recent advancements in pediatric pulmonary medicine have prolonged the expected lifespan of many previously fatal diagnoses, and I have realized that, despite these innovations, there remains very little communication between the adult and pediatric subspecialists,” Dr. Kapania said. “There is minimal education on congenital pulmonary pathology in adult medicine and, perhaps equally as important, negligible instruction on the cultural and social changes that patients experience when they transition from pediatric to adult providers.”
In residency, Dr. Kapania witnessed the success of cystic fibrosis (CF) clinics and hopes to leverage that experience to advance transitional care across disease states. Using the guidelines set to transition patients with CF from pediatric to adult care as a model, Dr. Kapania will focus her time on creating a streamlined process for patients living with severe asthma and patients with neuromuscular diseases who are chronically vented.
“Patients who are chronically vented tend not to have a lot of resources dedicated to them and are a resource- and time-heavy population,” Dr. Kapania said. “Because there is no defined process to transition these patients, we tend to see pediatric providers hold on to these patients for a lot longer than they do with [patients with CF]. A set of evidence-based practices would go a long way in this space.”
Through the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship, Dr. Kapania will work closely with the program’s selected mentor, Başak Çoruh, MD, FCCP, who is an Associate Professor of Pulmonary, Critical Care, and Sleep Medicine and Director of the Pulmonary and Critical Care Medicine fellowship program at the University of Washington.
“I’m looking forward to working with Dr. Çoruh for career guidance and for support of my area of interest within [pulmonary and critical care medicine],” Dr. Kapania said. “She is an established physician who has a lot of insight to share, and this is a great opportunity to make the best of my fellowship.”
This is the first year for the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship. To learn more about the scholarship, visit the CHEST website.
During residency training at the Rush University Medical Center in Internal Medicine and Pediatrics, Esha Kapania, MD, quickly became interested in the pulmonary pathologies that span the life of a patient, beginning in childhood and lasting into adulthood.
Now in her first year of fellowship at the University of Louisville and as the recipient of the 2024 Medical Educator Scholar Diversity Fellowship from CHEST and the Association of Pulmonary and Critical Care Medicine Program Directors (APCCMPD), Dr. Kapania will utilize the support of the program to explore this space.
“Recent advancements in pediatric pulmonary medicine have prolonged the expected lifespan of many previously fatal diagnoses, and I have realized that, despite these innovations, there remains very little communication between the adult and pediatric subspecialists,” Dr. Kapania said. “There is minimal education on congenital pulmonary pathology in adult medicine and, perhaps equally as important, negligible instruction on the cultural and social changes that patients experience when they transition from pediatric to adult providers.”
In residency, Dr. Kapania witnessed the success of cystic fibrosis (CF) clinics and hopes to leverage that experience to advance transitional care across disease states. Using the guidelines set to transition patients with CF from pediatric to adult care as a model, Dr. Kapania will focus her time on creating a streamlined process for patients living with severe asthma and patients with neuromuscular diseases who are chronically vented.
“Patients who are chronically vented tend not to have a lot of resources dedicated to them and are a resource- and time-heavy population,” Dr. Kapania said. “Because there is no defined process to transition these patients, we tend to see pediatric providers hold on to these patients for a lot longer than they do with [patients with CF]. A set of evidence-based practices would go a long way in this space.”
Through the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship, Dr. Kapania will work closely with the program’s selected mentor, Başak Çoruh, MD, FCCP, who is an Associate Professor of Pulmonary, Critical Care, and Sleep Medicine and Director of the Pulmonary and Critical Care Medicine fellowship program at the University of Washington.
“I’m looking forward to working with Dr. Çoruh for career guidance and for support of my area of interest within [pulmonary and critical care medicine],” Dr. Kapania said. “She is an established physician who has a lot of insight to share, and this is a great opportunity to make the best of my fellowship.”
This is the first year for the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship. To learn more about the scholarship, visit the CHEST website.
During residency training at the Rush University Medical Center in Internal Medicine and Pediatrics, Esha Kapania, MD, quickly became interested in the pulmonary pathologies that span the life of a patient, beginning in childhood and lasting into adulthood.
Now in her first year of fellowship at the University of Louisville and as the recipient of the 2024 Medical Educator Scholar Diversity Fellowship from CHEST and the Association of Pulmonary and Critical Care Medicine Program Directors (APCCMPD), Dr. Kapania will utilize the support of the program to explore this space.
“Recent advancements in pediatric pulmonary medicine have prolonged the expected lifespan of many previously fatal diagnoses, and I have realized that, despite these innovations, there remains very little communication between the adult and pediatric subspecialists,” Dr. Kapania said. “There is minimal education on congenital pulmonary pathology in adult medicine and, perhaps equally as important, negligible instruction on the cultural and social changes that patients experience when they transition from pediatric to adult providers.”
In residency, Dr. Kapania witnessed the success of cystic fibrosis (CF) clinics and hopes to leverage that experience to advance transitional care across disease states. Using the guidelines set to transition patients with CF from pediatric to adult care as a model, Dr. Kapania will focus her time on creating a streamlined process for patients living with severe asthma and patients with neuromuscular diseases who are chronically vented.
“Patients who are chronically vented tend not to have a lot of resources dedicated to them and are a resource- and time-heavy population,” Dr. Kapania said. “Because there is no defined process to transition these patients, we tend to see pediatric providers hold on to these patients for a lot longer than they do with [patients with CF]. A set of evidence-based practices would go a long way in this space.”
Through the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship, Dr. Kapania will work closely with the program’s selected mentor, Başak Çoruh, MD, FCCP, who is an Associate Professor of Pulmonary, Critical Care, and Sleep Medicine and Director of the Pulmonary and Critical Care Medicine fellowship program at the University of Washington.
“I’m looking forward to working with Dr. Çoruh for career guidance and for support of my area of interest within [pulmonary and critical care medicine],” Dr. Kapania said. “She is an established physician who has a lot of insight to share, and this is a great opportunity to make the best of my fellowship.”
This is the first year for the APCCMPD and CHEST Medical Educator Scholar Diversity Fellowship. To learn more about the scholarship, visit the CHEST website.
Transesophageal ultrasound: The future of ultrasound in the ICU
Thoracic Oncology and Chest Procedures Network
Ultrasound and Chest Imaging Section
Historically, transesophageal ultrasound (TEE) has been regarded as a diagnostic and management tool for structural heart disease in relatively stable patients. However, TEE is more commonly being utilized by intensivists as a first-line tool in the diagnostics and management of patients in the ICU.
TEE, with its unobstructed superior cardiac views, facilitates rapid diagnosis in undifferentiated shock and guides appropriate resuscitation efforts. Studies have shown that TEE alters management strategies in 40% of cases, following transthoracic echocardiography with an extremely low complication rate of 2% to 3% (primarily in the form of self-limited gastrointestinal bleeding).1,2,3,4
TEE also provides ultrasonographic evaluation of the lungs through transesophageal lung ultrasound (TELUS). TELUS allows for visualization of all six traditional lung zones utilized in traditional lung ultrasound.5 Patients with severe acute respiratory distress syndrome may greatly benefit from TEE utilization. TEE enables early detection of right ventricular dysfunction, aids in fluid management, and assesses the severity of lung consolidation, thereby facilitating prompt utilization of prone positioning or adjustments in positive end-expiratory pressure.
Cardiac arrest is another unique opportunity for TEE utilization by providing real-time cardiac visualization during active cardiopulmonary resuscitation. This facilitates optimal chest compression positioning, early recognition of arrhythmia, timely identification of reversible cause, and procedural guidance for ECMO-assisted CPR.6 TEE is an invaluable tool for the modern-day intensivist, providing rapid and accurate assessments, and therefore holds the potential to become standard of care in the ICU.
References
1. Prager R, Bowdridge J, Pratte M, Cheng J, McInnes MD, Arntfield R. Indications, clinical impact, and complications of critical care transesophageal echocardiography: a scoping review. J Intensive Care Med. 2023;38(3):245-272. Preprint. Posted online July 19, 2022. PMID: 35854414; PMCID: PMC9806486. doi: 10.1177/08850666221115348
2. Hüttemann E, Schelenz C, Kara F, Chatzinikolaou K, Reinhart K. The use and safety of transoesophageal echocardiography in the general ICU – a minireview. Acta Anaesthesiol Scand. 2004;48(7):827-36. PMID: 15242426. doi: 10.1111/j.0001-5172.2004.00423.x
3. Mayo PH, Narasimhan M, Koenig S. Critical care transesophageal echocardiography. Chest. 2015;148(5):1323-1332. PMID: 26204465. doi: 10.1378/chest.15-0260
4. Prager R, Ainsworth C, Arntfield R. Critical care transesophageal echocardiography for the resuscitation of shock: an important diagnostic skill for the modern intensivist. Chest. 2023;163(2):268-269. PMID: 36759112. doi: 10.1016/j.chest.2022.09.001
5. Cavayas YA, Girard M, Desjardins G, Denault AY. Transesophageal lung ultrasonography: a novel technique for investigating hypoxemia. Can J Anaesth. 2016;63(11):1266-76. Preprint. Posted online July 29, 2016. PMID: 27473720. doi: 10.1007/s12630-016-0702-2
6. Teran F, Prats MI, Nelson BP, et al. Focused transesophageal echocardiography during cardiac arrest resuscitation: JACC review wopic of the Week. J Am Coll Cardiol. 2020;76(6):745-754. PMID: 32762909. doi: 10.1016/j.jacc.2020.05.074
Thoracic Oncology and Chest Procedures Network
Ultrasound and Chest Imaging Section
Historically, transesophageal ultrasound (TEE) has been regarded as a diagnostic and management tool for structural heart disease in relatively stable patients. However, TEE is more commonly being utilized by intensivists as a first-line tool in the diagnostics and management of patients in the ICU.
TEE, with its unobstructed superior cardiac views, facilitates rapid diagnosis in undifferentiated shock and guides appropriate resuscitation efforts. Studies have shown that TEE alters management strategies in 40% of cases, following transthoracic echocardiography with an extremely low complication rate of 2% to 3% (primarily in the form of self-limited gastrointestinal bleeding).1,2,3,4
TEE also provides ultrasonographic evaluation of the lungs through transesophageal lung ultrasound (TELUS). TELUS allows for visualization of all six traditional lung zones utilized in traditional lung ultrasound.5 Patients with severe acute respiratory distress syndrome may greatly benefit from TEE utilization. TEE enables early detection of right ventricular dysfunction, aids in fluid management, and assesses the severity of lung consolidation, thereby facilitating prompt utilization of prone positioning or adjustments in positive end-expiratory pressure.
Cardiac arrest is another unique opportunity for TEE utilization by providing real-time cardiac visualization during active cardiopulmonary resuscitation. This facilitates optimal chest compression positioning, early recognition of arrhythmia, timely identification of reversible cause, and procedural guidance for ECMO-assisted CPR.6 TEE is an invaluable tool for the modern-day intensivist, providing rapid and accurate assessments, and therefore holds the potential to become standard of care in the ICU.
References
1. Prager R, Bowdridge J, Pratte M, Cheng J, McInnes MD, Arntfield R. Indications, clinical impact, and complications of critical care transesophageal echocardiography: a scoping review. J Intensive Care Med. 2023;38(3):245-272. Preprint. Posted online July 19, 2022. PMID: 35854414; PMCID: PMC9806486. doi: 10.1177/08850666221115348
2. Hüttemann E, Schelenz C, Kara F, Chatzinikolaou K, Reinhart K. The use and safety of transoesophageal echocardiography in the general ICU – a minireview. Acta Anaesthesiol Scand. 2004;48(7):827-36. PMID: 15242426. doi: 10.1111/j.0001-5172.2004.00423.x
3. Mayo PH, Narasimhan M, Koenig S. Critical care transesophageal echocardiography. Chest. 2015;148(5):1323-1332. PMID: 26204465. doi: 10.1378/chest.15-0260
4. Prager R, Ainsworth C, Arntfield R. Critical care transesophageal echocardiography for the resuscitation of shock: an important diagnostic skill for the modern intensivist. Chest. 2023;163(2):268-269. PMID: 36759112. doi: 10.1016/j.chest.2022.09.001
5. Cavayas YA, Girard M, Desjardins G, Denault AY. Transesophageal lung ultrasonography: a novel technique for investigating hypoxemia. Can J Anaesth. 2016;63(11):1266-76. Preprint. Posted online July 29, 2016. PMID: 27473720. doi: 10.1007/s12630-016-0702-2
6. Teran F, Prats MI, Nelson BP, et al. Focused transesophageal echocardiography during cardiac arrest resuscitation: JACC review wopic of the Week. J Am Coll Cardiol. 2020;76(6):745-754. PMID: 32762909. doi: 10.1016/j.jacc.2020.05.074
Thoracic Oncology and Chest Procedures Network
Ultrasound and Chest Imaging Section
Historically, transesophageal ultrasound (TEE) has been regarded as a diagnostic and management tool for structural heart disease in relatively stable patients. However, TEE is more commonly being utilized by intensivists as a first-line tool in the diagnostics and management of patients in the ICU.
TEE, with its unobstructed superior cardiac views, facilitates rapid diagnosis in undifferentiated shock and guides appropriate resuscitation efforts. Studies have shown that TEE alters management strategies in 40% of cases, following transthoracic echocardiography with an extremely low complication rate of 2% to 3% (primarily in the form of self-limited gastrointestinal bleeding).1,2,3,4
TEE also provides ultrasonographic evaluation of the lungs through transesophageal lung ultrasound (TELUS). TELUS allows for visualization of all six traditional lung zones utilized in traditional lung ultrasound.5 Patients with severe acute respiratory distress syndrome may greatly benefit from TEE utilization. TEE enables early detection of right ventricular dysfunction, aids in fluid management, and assesses the severity of lung consolidation, thereby facilitating prompt utilization of prone positioning or adjustments in positive end-expiratory pressure.
Cardiac arrest is another unique opportunity for TEE utilization by providing real-time cardiac visualization during active cardiopulmonary resuscitation. This facilitates optimal chest compression positioning, early recognition of arrhythmia, timely identification of reversible cause, and procedural guidance for ECMO-assisted CPR.6 TEE is an invaluable tool for the modern-day intensivist, providing rapid and accurate assessments, and therefore holds the potential to become standard of care in the ICU.
References
1. Prager R, Bowdridge J, Pratte M, Cheng J, McInnes MD, Arntfield R. Indications, clinical impact, and complications of critical care transesophageal echocardiography: a scoping review. J Intensive Care Med. 2023;38(3):245-272. Preprint. Posted online July 19, 2022. PMID: 35854414; PMCID: PMC9806486. doi: 10.1177/08850666221115348
2. Hüttemann E, Schelenz C, Kara F, Chatzinikolaou K, Reinhart K. The use and safety of transoesophageal echocardiography in the general ICU – a minireview. Acta Anaesthesiol Scand. 2004;48(7):827-36. PMID: 15242426. doi: 10.1111/j.0001-5172.2004.00423.x
3. Mayo PH, Narasimhan M, Koenig S. Critical care transesophageal echocardiography. Chest. 2015;148(5):1323-1332. PMID: 26204465. doi: 10.1378/chest.15-0260
4. Prager R, Ainsworth C, Arntfield R. Critical care transesophageal echocardiography for the resuscitation of shock: an important diagnostic skill for the modern intensivist. Chest. 2023;163(2):268-269. PMID: 36759112. doi: 10.1016/j.chest.2022.09.001
5. Cavayas YA, Girard M, Desjardins G, Denault AY. Transesophageal lung ultrasonography: a novel technique for investigating hypoxemia. Can J Anaesth. 2016;63(11):1266-76. Preprint. Posted online July 29, 2016. PMID: 27473720. doi: 10.1007/s12630-016-0702-2
6. Teran F, Prats MI, Nelson BP, et al. Focused transesophageal echocardiography during cardiac arrest resuscitation: JACC review wopic of the Week. J Am Coll Cardiol. 2020;76(6):745-754. PMID: 32762909. doi: 10.1016/j.jacc.2020.05.074
The pendulum swings in favor of corticosteroids
Critical Care Network
Sepsis/Shock Section
The pendulum swings in favor of corticosteroids and endorses the colloquialism among intensivists that no patient shall die without steroids, especially as it relates to sepsis and septic shock.
In 2018, we saw divergence among randomized controlled trials in the use of glucocorticoids for adults with septic shock such that hydrocortisone without the use of fludrocortisone showed no 90-day mortality benefit; however, hydrocortisone with fludrocortisone showed a 90-day mortality benefit.1,2 The Surviving Sepsis Guidelines in 2021 favored using low-dose corticosteroids in those with persistent vasopressor requirements in whom other core interventions had been instituted.
In 2023, a patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock included seven trials and failed to demonstrate a mortality benefit by relative risk in those who received hydrocortisone compared with placebo. Separately, a network meta-analysis with hydrocortisone plus enteral fludrocortisone was associated with a 90-day all-cause mortality. Of the secondary outcomes, these results offered a possible association of hydrocortisone with a decreased risk of ICU mortality and with increased vasopressor-free days.3
The 2024 Society of Critical Care Medicine recently shared an update of focused guidelines on the use of corticosteroids in sepsis, acute respiratory distress syndrome, and community-acquired pneumonia. These included a conditional recommendation to administer corticosteroids for patients with septic shock but recommended against high-dose/short-duration administration of corticosteroids in these patients. These guidelines were supported by data from 46 randomized controlled trials, which showed that corticosteroid use may reduce hospital/long-term mortality and ICU/short-term mortality, as well as result in higher rates of shock reversal and reduced organ dysfunction.
With the results of these meta-analyses and randomized controlled trials, clinicians should consider low-dose corticosteroids paired with fludrocortisone as a tool in treating patients with septic shock given that the short- and long-term benefits may exceed any risks.
References
1. Venkatesh B, et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018;378:797-808.
2. Annane D, et al. Hydrocortisone plus fludrocortisone for adults with septic shock. N Engl J Med. 2018;378:809-818.
3. Pirracchio R, et al. Patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock. NEJM Evid. 2023;2(6).
Critical Care Network
Sepsis/Shock Section
The pendulum swings in favor of corticosteroids and endorses the colloquialism among intensivists that no patient shall die without steroids, especially as it relates to sepsis and septic shock.
In 2018, we saw divergence among randomized controlled trials in the use of glucocorticoids for adults with septic shock such that hydrocortisone without the use of fludrocortisone showed no 90-day mortality benefit; however, hydrocortisone with fludrocortisone showed a 90-day mortality benefit.1,2 The Surviving Sepsis Guidelines in 2021 favored using low-dose corticosteroids in those with persistent vasopressor requirements in whom other core interventions had been instituted.
In 2023, a patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock included seven trials and failed to demonstrate a mortality benefit by relative risk in those who received hydrocortisone compared with placebo. Separately, a network meta-analysis with hydrocortisone plus enteral fludrocortisone was associated with a 90-day all-cause mortality. Of the secondary outcomes, these results offered a possible association of hydrocortisone with a decreased risk of ICU mortality and with increased vasopressor-free days.3
The 2024 Society of Critical Care Medicine recently shared an update of focused guidelines on the use of corticosteroids in sepsis, acute respiratory distress syndrome, and community-acquired pneumonia. These included a conditional recommendation to administer corticosteroids for patients with septic shock but recommended against high-dose/short-duration administration of corticosteroids in these patients. These guidelines were supported by data from 46 randomized controlled trials, which showed that corticosteroid use may reduce hospital/long-term mortality and ICU/short-term mortality, as well as result in higher rates of shock reversal and reduced organ dysfunction.
With the results of these meta-analyses and randomized controlled trials, clinicians should consider low-dose corticosteroids paired with fludrocortisone as a tool in treating patients with septic shock given that the short- and long-term benefits may exceed any risks.
References
1. Venkatesh B, et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018;378:797-808.
2. Annane D, et al. Hydrocortisone plus fludrocortisone for adults with septic shock. N Engl J Med. 2018;378:809-818.
3. Pirracchio R, et al. Patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock. NEJM Evid. 2023;2(6).
Critical Care Network
Sepsis/Shock Section
The pendulum swings in favor of corticosteroids and endorses the colloquialism among intensivists that no patient shall die without steroids, especially as it relates to sepsis and septic shock.
In 2018, we saw divergence among randomized controlled trials in the use of glucocorticoids for adults with septic shock such that hydrocortisone without the use of fludrocortisone showed no 90-day mortality benefit; however, hydrocortisone with fludrocortisone showed a 90-day mortality benefit.1,2 The Surviving Sepsis Guidelines in 2021 favored using low-dose corticosteroids in those with persistent vasopressor requirements in whom other core interventions had been instituted.
In 2023, a patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock included seven trials and failed to demonstrate a mortality benefit by relative risk in those who received hydrocortisone compared with placebo. Separately, a network meta-analysis with hydrocortisone plus enteral fludrocortisone was associated with a 90-day all-cause mortality. Of the secondary outcomes, these results offered a possible association of hydrocortisone with a decreased risk of ICU mortality and with increased vasopressor-free days.3
The 2024 Society of Critical Care Medicine recently shared an update of focused guidelines on the use of corticosteroids in sepsis, acute respiratory distress syndrome, and community-acquired pneumonia. These included a conditional recommendation to administer corticosteroids for patients with septic shock but recommended against high-dose/short-duration administration of corticosteroids in these patients. These guidelines were supported by data from 46 randomized controlled trials, which showed that corticosteroid use may reduce hospital/long-term mortality and ICU/short-term mortality, as well as result in higher rates of shock reversal and reduced organ dysfunction.
With the results of these meta-analyses and randomized controlled trials, clinicians should consider low-dose corticosteroids paired with fludrocortisone as a tool in treating patients with septic shock given that the short- and long-term benefits may exceed any risks.
References
1. Venkatesh B, et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018;378:797-808.
2. Annane D, et al. Hydrocortisone plus fludrocortisone for adults with septic shock. N Engl J Med. 2018;378:809-818.
3. Pirracchio R, et al. Patient-level meta-analysis of low-dose hydrocortisone in adults with septic shock. NEJM Evid. 2023;2(6).
Is it time to embrace a multinight sleep study?
Sleep Medicine Network
Respiratory-Related Sleep Disorders Section
Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1
Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3
The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.
Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.
References
1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007
2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC
3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE
Sleep Medicine Network
Respiratory-Related Sleep Disorders Section
Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1
Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3
The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.
Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.
References
1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007
2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC
3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE
Sleep Medicine Network
Respiratory-Related Sleep Disorders Section
Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1
Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3
The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.
Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.
References
1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007
2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC
3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE
The DEA Plans to Reschedule Marijuana: What Happens Next?
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
This class includes ketamine, acetaminophen with codeine, and buprenorphine.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
This class includes ketamine, acetaminophen with codeine, and buprenorphine.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
This class includes ketamine, acetaminophen with codeine, and buprenorphine.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
Asthma, COPD inhaler price caps set for summer
In addition to warmer weather, June will usher in changes in asthma and COPD inhaler costs for many patients, potentially reducing barriers to those seeing high prescription prices. Price ceilings have been set by some companies, likely following action earlier this year by a Senate Committee which pointed to higher costs of US inhalers compared with other countries.
Senator Sanders stated: “In my view, Americans who have asthma and COPD should not be forced to pay, in many cases, 10-70 times more for the same exact inhalers as patients in Europe and other parts of the world.”
Starting June 1, Boehringer Ingelheim will cap out-of-pocket costs for the company’s inhaler products for chronic lung disease and asthma at $35 per month, according to a March 7, 2024, press release from the German drugmaker’s US headquarters in Ridgefield, Conn. The reductions cover the full range of the company’s inhaler products for asthma and chronic obstructive pulmonary disease (COPD) including Atrovent, Combivent Respimat and Spiriva HandiHaler and Respimat, Stiolto Respimat and Striverdi Respimat. In the release, Boehringer Ingelheim USA Corporation’s President and CEO Jean-Michel Boers stated, “The US health care system is complex and often doesn’t work for patients, especially the most vulnerable. While we can’t fix the entire system alone, we are bringing forward a solution to make it fairer. We want to do our part to help patients living with COPD or asthma who struggle to pay for their medications.”
Similar announcements were made by AstraZeneca and GSK. GSK’s cap will go into effect on January 1, 2025, and includes Advair Diskus, Advair HFA, Anoro Ellipta, Arnuity Ellipta, Breo Ellipta, Incruse Ellipta, Serevent Diskus, Trelegy Ellipta, and Ventolin HFA. The AstraZeneca cap, which covers Airsupra, Bevespi Aerosphere, Breztri Aeroshpere, and Symbicort, goes into effect on June 1, 2024.
Senate statement on pricing
These companies plus Teva had received letters sent on January 8, 2024, by the members of the Senate Committee on Health, Education, Labor, and Pensions: senators Sanders, Baldwin, Luján and Markey. The letters cited enormous inhaler price discrepancies, for example $489 for Combivent Respimat in the United States but just $7 in France, and announced the conduct of an investigation into efforts by these companies to artificially inflate and manipulate prices of asthma inhalers that have been on the market for decades. A statement from Sen. Sanders’ office noted that AstraZeneca, GSK, and Teva made more than $25 billion in revenue from inhalers alone in the past 5 years (Boehringer Ingelheim does not provide public US inhaler revenue information).
Suit claims generic delay
A federal lawsuit filed in Boston on March 6, according to a Reuters brief from March 7, cited Boehringer for improperly submitting patents to the US Food and Drug Administration (FDA). The purpose of those patents, the suit charges, was to delay generic competition and inflate Combivent Respimat and Spiriva Respimat inhaler prices.
Inhaler prices soared in the United States, according to a March 10 U.S. News & World Report commentary by The Conversation, a nonprofit news organization, after the 2008 FDA ban on chlorofluorocarbon (CFC)-propellants led to the phase-out of CFC-containing inhalers and their replacement with hydrofluoroalkane-propellant inhalers. For the insured that meant an average out-of-pocket inhaler cost increase from $13.60 per prescription in 2004 to $25 in 2015. The current rate for the now nongeneric HFA-propelled but otherwise identical albuterol inhaler is $98. Competition from a more recently FDA-approved (2020) generic version has not been robust enough to effect meaningful price reductions, the report stated. While good insurance generally covers most of inhaler costs, the more than 25 million uninsured in 2023 faced steep market prices that put strain even on some insured, the CDC found, driving many in the United States to purchase from Mexican, Canadian, or other foreign pharmacies. The Teva QVAR REdiHaler corticosteroid inhaler, costing $9 in Germany, costs $286 in the US. Dosages, however, may not be identical. A first FDA-authorization of drug importing this past January applied only to agents for a limited number of disease states and pertained only to Florida, but may serve as a model for other states, according to the commentary.
“The announced price cap from Boehringer Ingelheim,” stated Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA) in a press release, “is a step toward improving access to essential asthma medicine and demonstrates that the voice of the asthma patient community is being heard.” The AAFA release noted further that asthma death rates, while declining overall, are triple in Blacks compared with Whites. Death rates, asthma rates, and rates of being uninsured or underinsured are much higher in Black and Puerto Rican populations than in Whites. The complex layers of the current US system, composed of pharmaceutical manufacturers, pharmacy benefit managers, insurance companies, employers, and federal policies often conspire against those people who need asthma drugs the most. AAFA research has shown that when drug prices become a barrier to treatment, people with asthma ration or simply discontinue their essential asthma medications. Beyond saved lives, access to asthma medications can reduce hospitalizations and lower the more than $82 billion in annual asthma costs to the US economy.
Sen. Sanders, on March 20, applauded the GSK announcement: “As Chairman of the Senate Health, Education, Labor, and Pensions Committee, I very much appreciate GlaxoSmithKline’s announcement today that Americans throughout the country with asthma and COPD will pay no more than $35 for the brand name inhalers they manufacture. I look forward to working with GSK to make sure that this decision reaches as many patients as possible.”
“Inhaled medications continue to be an essential part of the therapy for patients with asthma, COPD, and other respiratory conditions,” said Diego J. Maselli, professor and chief, Division of Pulmonary Diseases & Critical Care, UT Health at San Antonio, San Antonio, Texas, in an interview with CHEST Physician. He added, “Unfortunately, with increasing cost of these and other treatments, access has been challenging for many patients. Patients, families, and providers constantly experience frustration with the difficulties of obtaining these lifesaving medications, and cost is the main barrier. Even those with ample insurance coverage face difficult challenges, as the high prices of these medications motivate insurance carriers to constantly adjust what is the ‘preferred’ option among inhalers. Regrettably, noncompliance and nonadherence to inhaled therapies has been linked to poor patient outcomes and increased health care utilization in both asthma and COPD. Because of the high prevalence of these diseases in the US and worldwide, efforts to increase the access of these vital medications has been a priority. With the leveling of the prices of these medications across the world, we hope that there will be both improved access and, as a consequence, better patient outcomes.”
In addition to warmer weather, June will usher in changes in asthma and COPD inhaler costs for many patients, potentially reducing barriers to those seeing high prescription prices. Price ceilings have been set by some companies, likely following action earlier this year by a Senate Committee which pointed to higher costs of US inhalers compared with other countries.
Senator Sanders stated: “In my view, Americans who have asthma and COPD should not be forced to pay, in many cases, 10-70 times more for the same exact inhalers as patients in Europe and other parts of the world.”
Starting June 1, Boehringer Ingelheim will cap out-of-pocket costs for the company’s inhaler products for chronic lung disease and asthma at $35 per month, according to a March 7, 2024, press release from the German drugmaker’s US headquarters in Ridgefield, Conn. The reductions cover the full range of the company’s inhaler products for asthma and chronic obstructive pulmonary disease (COPD) including Atrovent, Combivent Respimat and Spiriva HandiHaler and Respimat, Stiolto Respimat and Striverdi Respimat. In the release, Boehringer Ingelheim USA Corporation’s President and CEO Jean-Michel Boers stated, “The US health care system is complex and often doesn’t work for patients, especially the most vulnerable. While we can’t fix the entire system alone, we are bringing forward a solution to make it fairer. We want to do our part to help patients living with COPD or asthma who struggle to pay for their medications.”
Similar announcements were made by AstraZeneca and GSK. GSK’s cap will go into effect on January 1, 2025, and includes Advair Diskus, Advair HFA, Anoro Ellipta, Arnuity Ellipta, Breo Ellipta, Incruse Ellipta, Serevent Diskus, Trelegy Ellipta, and Ventolin HFA. The AstraZeneca cap, which covers Airsupra, Bevespi Aerosphere, Breztri Aeroshpere, and Symbicort, goes into effect on June 1, 2024.
Senate statement on pricing
These companies plus Teva had received letters sent on January 8, 2024, by the members of the Senate Committee on Health, Education, Labor, and Pensions: senators Sanders, Baldwin, Luján and Markey. The letters cited enormous inhaler price discrepancies, for example $489 for Combivent Respimat in the United States but just $7 in France, and announced the conduct of an investigation into efforts by these companies to artificially inflate and manipulate prices of asthma inhalers that have been on the market for decades. A statement from Sen. Sanders’ office noted that AstraZeneca, GSK, and Teva made more than $25 billion in revenue from inhalers alone in the past 5 years (Boehringer Ingelheim does not provide public US inhaler revenue information).
Suit claims generic delay
A federal lawsuit filed in Boston on March 6, according to a Reuters brief from March 7, cited Boehringer for improperly submitting patents to the US Food and Drug Administration (FDA). The purpose of those patents, the suit charges, was to delay generic competition and inflate Combivent Respimat and Spiriva Respimat inhaler prices.
Inhaler prices soared in the United States, according to a March 10 U.S. News & World Report commentary by The Conversation, a nonprofit news organization, after the 2008 FDA ban on chlorofluorocarbon (CFC)-propellants led to the phase-out of CFC-containing inhalers and their replacement with hydrofluoroalkane-propellant inhalers. For the insured that meant an average out-of-pocket inhaler cost increase from $13.60 per prescription in 2004 to $25 in 2015. The current rate for the now nongeneric HFA-propelled but otherwise identical albuterol inhaler is $98. Competition from a more recently FDA-approved (2020) generic version has not been robust enough to effect meaningful price reductions, the report stated. While good insurance generally covers most of inhaler costs, the more than 25 million uninsured in 2023 faced steep market prices that put strain even on some insured, the CDC found, driving many in the United States to purchase from Mexican, Canadian, or other foreign pharmacies. The Teva QVAR REdiHaler corticosteroid inhaler, costing $9 in Germany, costs $286 in the US. Dosages, however, may not be identical. A first FDA-authorization of drug importing this past January applied only to agents for a limited number of disease states and pertained only to Florida, but may serve as a model for other states, according to the commentary.
“The announced price cap from Boehringer Ingelheim,” stated Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA) in a press release, “is a step toward improving access to essential asthma medicine and demonstrates that the voice of the asthma patient community is being heard.” The AAFA release noted further that asthma death rates, while declining overall, are triple in Blacks compared with Whites. Death rates, asthma rates, and rates of being uninsured or underinsured are much higher in Black and Puerto Rican populations than in Whites. The complex layers of the current US system, composed of pharmaceutical manufacturers, pharmacy benefit managers, insurance companies, employers, and federal policies often conspire against those people who need asthma drugs the most. AAFA research has shown that when drug prices become a barrier to treatment, people with asthma ration or simply discontinue their essential asthma medications. Beyond saved lives, access to asthma medications can reduce hospitalizations and lower the more than $82 billion in annual asthma costs to the US economy.
Sen. Sanders, on March 20, applauded the GSK announcement: “As Chairman of the Senate Health, Education, Labor, and Pensions Committee, I very much appreciate GlaxoSmithKline’s announcement today that Americans throughout the country with asthma and COPD will pay no more than $35 for the brand name inhalers they manufacture. I look forward to working with GSK to make sure that this decision reaches as many patients as possible.”
“Inhaled medications continue to be an essential part of the therapy for patients with asthma, COPD, and other respiratory conditions,” said Diego J. Maselli, professor and chief, Division of Pulmonary Diseases & Critical Care, UT Health at San Antonio, San Antonio, Texas, in an interview with CHEST Physician. He added, “Unfortunately, with increasing cost of these and other treatments, access has been challenging for many patients. Patients, families, and providers constantly experience frustration with the difficulties of obtaining these lifesaving medications, and cost is the main barrier. Even those with ample insurance coverage face difficult challenges, as the high prices of these medications motivate insurance carriers to constantly adjust what is the ‘preferred’ option among inhalers. Regrettably, noncompliance and nonadherence to inhaled therapies has been linked to poor patient outcomes and increased health care utilization in both asthma and COPD. Because of the high prevalence of these diseases in the US and worldwide, efforts to increase the access of these vital medications has been a priority. With the leveling of the prices of these medications across the world, we hope that there will be both improved access and, as a consequence, better patient outcomes.”
In addition to warmer weather, June will usher in changes in asthma and COPD inhaler costs for many patients, potentially reducing barriers to those seeing high prescription prices. Price ceilings have been set by some companies, likely following action earlier this year by a Senate Committee which pointed to higher costs of US inhalers compared with other countries.
Senator Sanders stated: “In my view, Americans who have asthma and COPD should not be forced to pay, in many cases, 10-70 times more for the same exact inhalers as patients in Europe and other parts of the world.”
Starting June 1, Boehringer Ingelheim will cap out-of-pocket costs for the company’s inhaler products for chronic lung disease and asthma at $35 per month, according to a March 7, 2024, press release from the German drugmaker’s US headquarters in Ridgefield, Conn. The reductions cover the full range of the company’s inhaler products for asthma and chronic obstructive pulmonary disease (COPD) including Atrovent, Combivent Respimat and Spiriva HandiHaler and Respimat, Stiolto Respimat and Striverdi Respimat. In the release, Boehringer Ingelheim USA Corporation’s President and CEO Jean-Michel Boers stated, “The US health care system is complex and often doesn’t work for patients, especially the most vulnerable. While we can’t fix the entire system alone, we are bringing forward a solution to make it fairer. We want to do our part to help patients living with COPD or asthma who struggle to pay for their medications.”
Similar announcements were made by AstraZeneca and GSK. GSK’s cap will go into effect on January 1, 2025, and includes Advair Diskus, Advair HFA, Anoro Ellipta, Arnuity Ellipta, Breo Ellipta, Incruse Ellipta, Serevent Diskus, Trelegy Ellipta, and Ventolin HFA. The AstraZeneca cap, which covers Airsupra, Bevespi Aerosphere, Breztri Aeroshpere, and Symbicort, goes into effect on June 1, 2024.
Senate statement on pricing
These companies plus Teva had received letters sent on January 8, 2024, by the members of the Senate Committee on Health, Education, Labor, and Pensions: senators Sanders, Baldwin, Luján and Markey. The letters cited enormous inhaler price discrepancies, for example $489 for Combivent Respimat in the United States but just $7 in France, and announced the conduct of an investigation into efforts by these companies to artificially inflate and manipulate prices of asthma inhalers that have been on the market for decades. A statement from Sen. Sanders’ office noted that AstraZeneca, GSK, and Teva made more than $25 billion in revenue from inhalers alone in the past 5 years (Boehringer Ingelheim does not provide public US inhaler revenue information).
Suit claims generic delay
A federal lawsuit filed in Boston on March 6, according to a Reuters brief from March 7, cited Boehringer for improperly submitting patents to the US Food and Drug Administration (FDA). The purpose of those patents, the suit charges, was to delay generic competition and inflate Combivent Respimat and Spiriva Respimat inhaler prices.
Inhaler prices soared in the United States, according to a March 10 U.S. News & World Report commentary by The Conversation, a nonprofit news organization, after the 2008 FDA ban on chlorofluorocarbon (CFC)-propellants led to the phase-out of CFC-containing inhalers and their replacement with hydrofluoroalkane-propellant inhalers. For the insured that meant an average out-of-pocket inhaler cost increase from $13.60 per prescription in 2004 to $25 in 2015. The current rate for the now nongeneric HFA-propelled but otherwise identical albuterol inhaler is $98. Competition from a more recently FDA-approved (2020) generic version has not been robust enough to effect meaningful price reductions, the report stated. While good insurance generally covers most of inhaler costs, the more than 25 million uninsured in 2023 faced steep market prices that put strain even on some insured, the CDC found, driving many in the United States to purchase from Mexican, Canadian, or other foreign pharmacies. The Teva QVAR REdiHaler corticosteroid inhaler, costing $9 in Germany, costs $286 in the US. Dosages, however, may not be identical. A first FDA-authorization of drug importing this past January applied only to agents for a limited number of disease states and pertained only to Florida, but may serve as a model for other states, according to the commentary.
“The announced price cap from Boehringer Ingelheim,” stated Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA) in a press release, “is a step toward improving access to essential asthma medicine and demonstrates that the voice of the asthma patient community is being heard.” The AAFA release noted further that asthma death rates, while declining overall, are triple in Blacks compared with Whites. Death rates, asthma rates, and rates of being uninsured or underinsured are much higher in Black and Puerto Rican populations than in Whites. The complex layers of the current US system, composed of pharmaceutical manufacturers, pharmacy benefit managers, insurance companies, employers, and federal policies often conspire against those people who need asthma drugs the most. AAFA research has shown that when drug prices become a barrier to treatment, people with asthma ration or simply discontinue their essential asthma medications. Beyond saved lives, access to asthma medications can reduce hospitalizations and lower the more than $82 billion in annual asthma costs to the US economy.
Sen. Sanders, on March 20, applauded the GSK announcement: “As Chairman of the Senate Health, Education, Labor, and Pensions Committee, I very much appreciate GlaxoSmithKline’s announcement today that Americans throughout the country with asthma and COPD will pay no more than $35 for the brand name inhalers they manufacture. I look forward to working with GSK to make sure that this decision reaches as many patients as possible.”
“Inhaled medications continue to be an essential part of the therapy for patients with asthma, COPD, and other respiratory conditions,” said Diego J. Maselli, professor and chief, Division of Pulmonary Diseases & Critical Care, UT Health at San Antonio, San Antonio, Texas, in an interview with CHEST Physician. He added, “Unfortunately, with increasing cost of these and other treatments, access has been challenging for many patients. Patients, families, and providers constantly experience frustration with the difficulties of obtaining these lifesaving medications, and cost is the main barrier. Even those with ample insurance coverage face difficult challenges, as the high prices of these medications motivate insurance carriers to constantly adjust what is the ‘preferred’ option among inhalers. Regrettably, noncompliance and nonadherence to inhaled therapies has been linked to poor patient outcomes and increased health care utilization in both asthma and COPD. Because of the high prevalence of these diseases in the US and worldwide, efforts to increase the access of these vital medications has been a priority. With the leveling of the prices of these medications across the world, we hope that there will be both improved access and, as a consequence, better patient outcomes.”
Prospect of Better Hours, Less Burnout Fuels Locum Tenens
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.