CHEST Physician

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)

What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.

Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.

Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.

While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.

Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.

Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.

Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.

Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.

Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
 

Promising Treatments Have Emerged

Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.

Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.

“This is something tangible that we can offer to patients,” she said.

Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.

For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.

“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.

Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.

Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.

It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
 

Clinical Trials Exploring New Therapies

Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.

Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.

Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.

Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.

She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
 

Lack of Urgency Holds Back Progress

Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.

“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.

Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.

He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.

“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”

A version of this article first appeared on Medscape.com.

Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)

What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.

Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.

Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.

While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.

Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.

Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.

Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.

Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.

Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
 

Promising Treatments Have Emerged

Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.

Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.

“This is something tangible that we can offer to patients,” she said.

Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.

For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.

“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.

Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.

Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.

It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
 

Clinical Trials Exploring New Therapies

Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.

Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.

Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.

Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.

She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
 

Lack of Urgency Holds Back Progress

Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.

“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.

Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.

He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.

“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”

A version of this article first appeared on Medscape.com.

Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)

What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.

Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.

Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.

While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.

Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.

Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.

Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.

Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.

Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
 

Promising Treatments Have Emerged

Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.

Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.

“This is something tangible that we can offer to patients,” she said.

Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.

For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.

“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.

Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.

Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.

It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
 

Clinical Trials Exploring New Therapies

Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.

Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.

Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.

Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.

She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
 

Lack of Urgency Holds Back Progress

Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.

“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.

Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.

He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.

“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”

A version of this article first appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

• High pollen concentrations in the days before a thunderstorm
• Precipitation and high humidity, thunderstorms, and lightning
• Sudden temperature changes
• Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

• Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
• Avoid outdoor activities on risky days.
• Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
• Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

• High pollen concentrations in the days before a thunderstorm
• Precipitation and high humidity, thunderstorms, and lightning
• Sudden temperature changes
• Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

• Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
• Avoid outdoor activities on risky days.
• Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
• Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

• High pollen concentrations in the days before a thunderstorm
• Precipitation and high humidity, thunderstorms, and lightning
• Sudden temperature changes
• Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

• Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
• Avoid outdoor activities on risky days.
• Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
• Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.