CHEST Physician

Approximately half of US adult smokers tried to quit in 2022, but fewer than 40% used counseling or medication, and half received assistance or advice about quitting from clinicians, based on a review in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Previous research has shown that clinician intervention and evidence-based treatment increase the odds that smokers can quit successfully, but the extent to which these interventions are applied in practice has not been well studied, the researchers noted. 

Although great progress has been made in reducing cigarette smoking in the United States, disparities remain, both in use and in cessation, with an estimated 28.8 million adults reporting cigarette smoking in 2022, lead author Brenna VanFrank, MD, MSPH, said in an interview.

“Cigarette smoking remains the leading preventable cause of death and disease in the United States,” said Dr. VanFrank, Senior Medical Officer, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion.

In a new review, the researchers examined data from the 2022 National Health Interview Survey. The study population included 27,651 adults aged 18 years and older. Current smoking was defined as currently smoking each day or some days and ever having smoked at least 100 cigarettes. The survey assessed the individuals’ interest in quitting, past-year quit attempts, recent quitting success, receipt of healthcare professional advice about quitting, use of counseling to help quit, and use of medication to help quit.

In 2022, approximately two thirds (67.7%) of the 28.8 million adult smokers in the United States wanted to quit, half (53.3%) tried to quit, but only 8.8% were successful. Of those who reported trying to quit, 38.3% used counseling or medication. Of these, 36.3% used medication, 7.3% used counseling, and 5.3% used both.

Indicators of smoking cessation varied by health characteristics and sociodemographic factors, with the highest prevalence of attempts to quit smoking in the past year among adults aged 18-24 years and the lowest among those aged 45-64 years (74.4% vs 47.5%).

Rates of successful quitting were highest among individuals with higher levels of education and income, and use of smoking cessation treatment was highest among White adults (42.7%), followed by non-Hispanic adults of another race, Black adults, and Hispanic adults (33.6%, 32.6%, and 28.8%, respectively).

Smokers of menthol cigarettes had similarly low success rates for quitting (< 10%), although they were significantly more likely than nonmenthol cigarette smokers to express interest in quitting (72.2% vs 65.4%). Smokers of menthol cigarettes also had significantly lower prevalences than smokers of nonmenthol cigarettes of receiving clinician advance to quit and using treatment strategies (both P < .05).

The study findings were limited by several factors including the use of self-reports, which may be subject to bias, and a lack of data on institutionalized adults or adults in the military, which may limit generalizability of the findings to those populations, the researchers noted. 

However, the results suggest that opportunities exist to increase smoking cessation across public health and healthcare sectors by expanding access to and use of services and supports to help smokers quit, they wrote.
 

Ensuring Support for All Smokers Seeking to Quit

The takeaway for clinical practice remains that quitting smoking “is one of the most important actions people who smoke can take to improve their health,” Dr. VanFrank said in an interview.

“It is important to ensure everyone has an opportunity to quit smoking and has access to proven treatments to help them be successful,” she emphasized. Strategies that include behavioral counseling, cessation medications, and advice and support from healthcare professionals can increase quit success. Given that tobacco dependence is a chronic, relapsing condition driven by addiction to nicotine, quitting successfully often takes multiple tries, and those trying to quit may need long-term support and repeated treatment. 

“Health systems changes, such as adoption of treatment protocols and standardized clinical work flows, can systematize clinical treatment delivery, and such changes might also serve to increase treatment access for the 75% of adults who smoke who see a healthcare professional in a given year,” said Dr. VanFrank.

As for additional research, “continued surveillance of tobacco use and cessation-related behaviors will help us monitor progress and identify continued opportunities to eliminate tobacco product use and tobacco-related disparities,” Dr. VanFrank said.

“We know a lot about what works to help people successfully quit smoking and what we can do to support people in making quit attempts,” she said. Including equitable opportunities in all commercial tobacco prevention and control efforts has the potential to reduce tobacco-related health disparities.

Overall smoking prevalence in the United States and the current study shows that most smokers would like to quit, David M. Mannino, MD, a pulmonologist and professor of medicine at the University of Kentucky, Lexington, said in an interview. The lack of success experienced by many smokers seeking to quit emphasizes the highly addictive nature of nicotine products, which cause death and disease when used as directed, added Dr. Mannino, who was not involved in the study.

The results of the review were not surprising, and reflect where tobacco treatment has been for the past 20 years, said Dr. Mannino. The good news is that smoking prevalence has continued to drop in the United States over the past 15 years. However, some bad news is that use of e-cigarettes/vaping is still increasing, especially in younger populations, and new nicotine delivery systems, such as pouches (Zyn) are addicting a new generation.
 

Always Ask About Smoking

In practice, “clinicians should always ask patients about cigarette smoking, as well as vaping and other nicotine use, advise them to quit, and refer them to tobacco treatment experts,” Dr. Mannino emphasized.

The bottom line is that better treatments are needed for tobacco/nicotine addiction, Dr. Mannino said. “Although we have come a long way, we have a long way to go as millions of smokers in the US and globally would like to quit.”

Tobacco-related disease continues to be the number one cause of morbidly and mortality in the United States, and although many current smokers want to quit, most are not successful, Jamie Garfield, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, said in an interview.

“This review highlights the sheer number of current cigarette smokers who want to quit, how many of them attempted to quit, and how many of those were successful,” said Dr. Garfield, who was not involved in the study. Understanding the characteristics of individuals who are more or less likely to successfully quit smoking can help public health and healthcare sectors to increase smoking cessation by expanding access to and use of services and supports. 

“We have to do better to control the sale of tobacco products and make tobacco cessation more accessible to everyone,” Dr. Garfield said. In addition, clinicians need to be consistent in asking patients about tobacco use. “If we don’t ask, we will not know who needs help.” Behavioral counseling helps, as does pharmacotherapy, and the two together are more effective than either alone, she added.

Cessation services need to be tailored to the many demographic groups who use tobacco products, said Dr. Garfield. “Just as marketing campaigns directed to older adults will be different from those directed to young adults, so too must cessation resources. Providers need better options to choose from with regard to cessation resources and behavioral counseling sessions. They need to be aware of what motivates one group of people to smoke and how they can be inspired to quit, including which pharmacotherapies are affordable, available, and will work; the same strategies will not work for all people”

The study was supported by the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion. The researchers had no financial conflicts to disclose. Dr. Mannino disclosed serving as an expert witness for on tobacco use and tobacco-caused disease on behalf of people suing the tobacco and vaping industries. Dr. Garfield had no financial conflicts to disclose.

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

Approximately half of US adult smokers tried to quit in 2022, but fewer than 40% used counseling or medication, and half received assistance or advice about quitting from clinicians, based on a review in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Previous research has shown that clinician intervention and evidence-based treatment increase the odds that smokers can quit successfully, but the extent to which these interventions are applied in practice has not been well studied, the researchers noted. 

Although great progress has been made in reducing cigarette smoking in the United States, disparities remain, both in use and in cessation, with an estimated 28.8 million adults reporting cigarette smoking in 2022, lead author Brenna VanFrank, MD, MSPH, said in an interview.

“Cigarette smoking remains the leading preventable cause of death and disease in the United States,” said Dr. VanFrank, Senior Medical Officer, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion.

In a new review, the researchers examined data from the 2022 National Health Interview Survey. The study population included 27,651 adults aged 18 years and older. Current smoking was defined as currently smoking each day or some days and ever having smoked at least 100 cigarettes. The survey assessed the individuals’ interest in quitting, past-year quit attempts, recent quitting success, receipt of healthcare professional advice about quitting, use of counseling to help quit, and use of medication to help quit.

In 2022, approximately two thirds (67.7%) of the 28.8 million adult smokers in the United States wanted to quit, half (53.3%) tried to quit, but only 8.8% were successful. Of those who reported trying to quit, 38.3% used counseling or medication. Of these, 36.3% used medication, 7.3% used counseling, and 5.3% used both.

Indicators of smoking cessation varied by health characteristics and sociodemographic factors, with the highest prevalence of attempts to quit smoking in the past year among adults aged 18-24 years and the lowest among those aged 45-64 years (74.4% vs 47.5%).

Rates of successful quitting were highest among individuals with higher levels of education and income, and use of smoking cessation treatment was highest among White adults (42.7%), followed by non-Hispanic adults of another race, Black adults, and Hispanic adults (33.6%, 32.6%, and 28.8%, respectively).

Smokers of menthol cigarettes had similarly low success rates for quitting (< 10%), although they were significantly more likely than nonmenthol cigarette smokers to express interest in quitting (72.2% vs 65.4%). Smokers of menthol cigarettes also had significantly lower prevalences than smokers of nonmenthol cigarettes of receiving clinician advance to quit and using treatment strategies (both P < .05).

The study findings were limited by several factors including the use of self-reports, which may be subject to bias, and a lack of data on institutionalized adults or adults in the military, which may limit generalizability of the findings to those populations, the researchers noted. 

However, the results suggest that opportunities exist to increase smoking cessation across public health and healthcare sectors by expanding access to and use of services and supports to help smokers quit, they wrote.
 

Ensuring Support for All Smokers Seeking to Quit

The takeaway for clinical practice remains that quitting smoking “is one of the most important actions people who smoke can take to improve their health,” Dr. VanFrank said in an interview.

“It is important to ensure everyone has an opportunity to quit smoking and has access to proven treatments to help them be successful,” she emphasized. Strategies that include behavioral counseling, cessation medications, and advice and support from healthcare professionals can increase quit success. Given that tobacco dependence is a chronic, relapsing condition driven by addiction to nicotine, quitting successfully often takes multiple tries, and those trying to quit may need long-term support and repeated treatment. 

“Health systems changes, such as adoption of treatment protocols and standardized clinical work flows, can systematize clinical treatment delivery, and such changes might also serve to increase treatment access for the 75% of adults who smoke who see a healthcare professional in a given year,” said Dr. VanFrank.

As for additional research, “continued surveillance of tobacco use and cessation-related behaviors will help us monitor progress and identify continued opportunities to eliminate tobacco product use and tobacco-related disparities,” Dr. VanFrank said.

“We know a lot about what works to help people successfully quit smoking and what we can do to support people in making quit attempts,” she said. Including equitable opportunities in all commercial tobacco prevention and control efforts has the potential to reduce tobacco-related health disparities.

Overall smoking prevalence in the United States and the current study shows that most smokers would like to quit, David M. Mannino, MD, a pulmonologist and professor of medicine at the University of Kentucky, Lexington, said in an interview. The lack of success experienced by many smokers seeking to quit emphasizes the highly addictive nature of nicotine products, which cause death and disease when used as directed, added Dr. Mannino, who was not involved in the study.

The results of the review were not surprising, and reflect where tobacco treatment has been for the past 20 years, said Dr. Mannino. The good news is that smoking prevalence has continued to drop in the United States over the past 15 years. However, some bad news is that use of e-cigarettes/vaping is still increasing, especially in younger populations, and new nicotine delivery systems, such as pouches (Zyn) are addicting a new generation.
 

Always Ask About Smoking

In practice, “clinicians should always ask patients about cigarette smoking, as well as vaping and other nicotine use, advise them to quit, and refer them to tobacco treatment experts,” Dr. Mannino emphasized.

The bottom line is that better treatments are needed for tobacco/nicotine addiction, Dr. Mannino said. “Although we have come a long way, we have a long way to go as millions of smokers in the US and globally would like to quit.”

Tobacco-related disease continues to be the number one cause of morbidly and mortality in the United States, and although many current smokers want to quit, most are not successful, Jamie Garfield, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, said in an interview.

“This review highlights the sheer number of current cigarette smokers who want to quit, how many of them attempted to quit, and how many of those were successful,” said Dr. Garfield, who was not involved in the study. Understanding the characteristics of individuals who are more or less likely to successfully quit smoking can help public health and healthcare sectors to increase smoking cessation by expanding access to and use of services and supports. 

“We have to do better to control the sale of tobacco products and make tobacco cessation more accessible to everyone,” Dr. Garfield said. In addition, clinicians need to be consistent in asking patients about tobacco use. “If we don’t ask, we will not know who needs help.” Behavioral counseling helps, as does pharmacotherapy, and the two together are more effective than either alone, she added.

Cessation services need to be tailored to the many demographic groups who use tobacco products, said Dr. Garfield. “Just as marketing campaigns directed to older adults will be different from those directed to young adults, so too must cessation resources. Providers need better options to choose from with regard to cessation resources and behavioral counseling sessions. They need to be aware of what motivates one group of people to smoke and how they can be inspired to quit, including which pharmacotherapies are affordable, available, and will work; the same strategies will not work for all people”

The study was supported by the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion. The researchers had no financial conflicts to disclose. Dr. Mannino disclosed serving as an expert witness for on tobacco use and tobacco-caused disease on behalf of people suing the tobacco and vaping industries. Dr. Garfield had no financial conflicts to disclose.

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

Approximately half of US adult smokers tried to quit in 2022, but fewer than 40% used counseling or medication, and half received assistance or advice about quitting from clinicians, based on a review in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Previous research has shown that clinician intervention and evidence-based treatment increase the odds that smokers can quit successfully, but the extent to which these interventions are applied in practice has not been well studied, the researchers noted. 

Although great progress has been made in reducing cigarette smoking in the United States, disparities remain, both in use and in cessation, with an estimated 28.8 million adults reporting cigarette smoking in 2022, lead author Brenna VanFrank, MD, MSPH, said in an interview.

“Cigarette smoking remains the leading preventable cause of death and disease in the United States,” said Dr. VanFrank, Senior Medical Officer, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion.

In a new review, the researchers examined data from the 2022 National Health Interview Survey. The study population included 27,651 adults aged 18 years and older. Current smoking was defined as currently smoking each day or some days and ever having smoked at least 100 cigarettes. The survey assessed the individuals’ interest in quitting, past-year quit attempts, recent quitting success, receipt of healthcare professional advice about quitting, use of counseling to help quit, and use of medication to help quit.

In 2022, approximately two thirds (67.7%) of the 28.8 million adult smokers in the United States wanted to quit, half (53.3%) tried to quit, but only 8.8% were successful. Of those who reported trying to quit, 38.3% used counseling or medication. Of these, 36.3% used medication, 7.3% used counseling, and 5.3% used both.

Indicators of smoking cessation varied by health characteristics and sociodemographic factors, with the highest prevalence of attempts to quit smoking in the past year among adults aged 18-24 years and the lowest among those aged 45-64 years (74.4% vs 47.5%).

Rates of successful quitting were highest among individuals with higher levels of education and income, and use of smoking cessation treatment was highest among White adults (42.7%), followed by non-Hispanic adults of another race, Black adults, and Hispanic adults (33.6%, 32.6%, and 28.8%, respectively).

Smokers of menthol cigarettes had similarly low success rates for quitting (< 10%), although they were significantly more likely than nonmenthol cigarette smokers to express interest in quitting (72.2% vs 65.4%). Smokers of menthol cigarettes also had significantly lower prevalences than smokers of nonmenthol cigarettes of receiving clinician advance to quit and using treatment strategies (both P < .05).

The study findings were limited by several factors including the use of self-reports, which may be subject to bias, and a lack of data on institutionalized adults or adults in the military, which may limit generalizability of the findings to those populations, the researchers noted. 

However, the results suggest that opportunities exist to increase smoking cessation across public health and healthcare sectors by expanding access to and use of services and supports to help smokers quit, they wrote.
 

Ensuring Support for All Smokers Seeking to Quit

The takeaway for clinical practice remains that quitting smoking “is one of the most important actions people who smoke can take to improve their health,” Dr. VanFrank said in an interview.

“It is important to ensure everyone has an opportunity to quit smoking and has access to proven treatments to help them be successful,” she emphasized. Strategies that include behavioral counseling, cessation medications, and advice and support from healthcare professionals can increase quit success. Given that tobacco dependence is a chronic, relapsing condition driven by addiction to nicotine, quitting successfully often takes multiple tries, and those trying to quit may need long-term support and repeated treatment. 

“Health systems changes, such as adoption of treatment protocols and standardized clinical work flows, can systematize clinical treatment delivery, and such changes might also serve to increase treatment access for the 75% of adults who smoke who see a healthcare professional in a given year,” said Dr. VanFrank.

As for additional research, “continued surveillance of tobacco use and cessation-related behaviors will help us monitor progress and identify continued opportunities to eliminate tobacco product use and tobacco-related disparities,” Dr. VanFrank said.

“We know a lot about what works to help people successfully quit smoking and what we can do to support people in making quit attempts,” she said. Including equitable opportunities in all commercial tobacco prevention and control efforts has the potential to reduce tobacco-related health disparities.

Overall smoking prevalence in the United States and the current study shows that most smokers would like to quit, David M. Mannino, MD, a pulmonologist and professor of medicine at the University of Kentucky, Lexington, said in an interview. The lack of success experienced by many smokers seeking to quit emphasizes the highly addictive nature of nicotine products, which cause death and disease when used as directed, added Dr. Mannino, who was not involved in the study.

The results of the review were not surprising, and reflect where tobacco treatment has been for the past 20 years, said Dr. Mannino. The good news is that smoking prevalence has continued to drop in the United States over the past 15 years. However, some bad news is that use of e-cigarettes/vaping is still increasing, especially in younger populations, and new nicotine delivery systems, such as pouches (Zyn) are addicting a new generation.
 

Always Ask About Smoking

In practice, “clinicians should always ask patients about cigarette smoking, as well as vaping and other nicotine use, advise them to quit, and refer them to tobacco treatment experts,” Dr. Mannino emphasized.

The bottom line is that better treatments are needed for tobacco/nicotine addiction, Dr. Mannino said. “Although we have come a long way, we have a long way to go as millions of smokers in the US and globally would like to quit.”

Tobacco-related disease continues to be the number one cause of morbidly and mortality in the United States, and although many current smokers want to quit, most are not successful, Jamie Garfield, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, said in an interview.

“This review highlights the sheer number of current cigarette smokers who want to quit, how many of them attempted to quit, and how many of those were successful,” said Dr. Garfield, who was not involved in the study. Understanding the characteristics of individuals who are more or less likely to successfully quit smoking can help public health and healthcare sectors to increase smoking cessation by expanding access to and use of services and supports. 

“We have to do better to control the sale of tobacco products and make tobacco cessation more accessible to everyone,” Dr. Garfield said. In addition, clinicians need to be consistent in asking patients about tobacco use. “If we don’t ask, we will not know who needs help.” Behavioral counseling helps, as does pharmacotherapy, and the two together are more effective than either alone, she added.

Cessation services need to be tailored to the many demographic groups who use tobacco products, said Dr. Garfield. “Just as marketing campaigns directed to older adults will be different from those directed to young adults, so too must cessation resources. Providers need better options to choose from with regard to cessation resources and behavioral counseling sessions. They need to be aware of what motivates one group of people to smoke and how they can be inspired to quit, including which pharmacotherapies are affordable, available, and will work; the same strategies will not work for all people”

The study was supported by the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion. The researchers had no financial conflicts to disclose. Dr. Mannino disclosed serving as an expert witness for on tobacco use and tobacco-caused disease on behalf of people suing the tobacco and vaping industries. Dr. Garfield had no financial conflicts to disclose.

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

A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.

The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.

“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.

The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
 

Sustained, Long-Term Effect

Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.

Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”

Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.

Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.

The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.

Researchers allocated the dyads to the intervention or to a treatment as usual group.

About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.

The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.

The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.

The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.

The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.

The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.

The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.

The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).

Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.

“We saw a sustained effect, so not just immediately after the intervention, but afterwards at 8 months.”

As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.

In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.

She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.

Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.

Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
 

Encouraging Findings

Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.

“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said. 

The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added. 

An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.

Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.

He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”

The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.

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

A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.

The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.

“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.

The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
 

Sustained, Long-Term Effect

Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.

Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”

Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.

Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.

The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.

Researchers allocated the dyads to the intervention or to a treatment as usual group.

About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.

The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.

The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.

The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.

The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.

The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.

The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.

The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).

Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.

“We saw a sustained effect, so not just immediately after the intervention, but afterwards at 8 months.”

As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.

In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.

She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.

Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.

Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
 

Encouraging Findings

Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.

“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said. 

The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added. 

An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.

Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.

He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”

The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.

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

A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.

The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.

“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.

The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
 

Sustained, Long-Term Effect

Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.

Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”

Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.

Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.

The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.

Researchers allocated the dyads to the intervention or to a treatment as usual group.

About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.

The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.

The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.

The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.

The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.

The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.

The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.

The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).

Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.

“We saw a sustained effect, so not just immediately after the intervention, but afterwards at 8 months.”

As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.

In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.

She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.

Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.

Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
 

Encouraging Findings

Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.

“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said. 

The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added. 

An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.

Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.

He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”

The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.

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

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

TOPLINE:

Chronic exposure to air pollutants such as fine particulate matter ≤ 2.5 μm in diameter (PM_2.5), particulate matter ≤ 10 μm in diameter (PM₁₀), nitrogen dioxide (NO₂), and nitrogen oxides (NO_X) increased the risk for systemic lupus erythematosus (SLE) onset. The risk was highest among those with high genetic risk and high air-pollution exposure. 

METHODOLOGY:

• Researchers prospectively investigated the association between long-term exposure to air pollutants and incident SLE in 459,815 participants from the UK Biobank.
• A land-use regression model was used to quantify the annual average air pollution concentrations, including PM_2.5, PM₁₀, NO₂, and NO_X.
• The genetic susceptibility to lupus was assessed using polygenic risk scores (PRS), and the participants were classified into low–, intermediate–, or high–genetic-risk groups based on the tertiles of PRS.
• The joint effect of air pollutants and genetic susceptibility to lupus on the risk for incident SLE was evaluated, with the reference group consisting of participants with a low genetic risk and low exposure to air pollution.

TAKEAWAY: 

• Over a median follow-up period of 11.77 years, 399 new cases of SLE were identified.
• The odds of developing SLE were higher among participants with high genetic risk than among those with low genetic risk (hazard ratio [HR], 3.45; P < .001 for trend).
• The risk for developing SLE was even higher among participants with a high genetic risk and high exposure to PM_2.5 (adjusted HR [aHR], 4.16; 95% CI, 2.67-6.49), PM₁₀ (aHR, 5.31; 95% CI, 3.30-8.55), NO₂ (aHR, 5.61; 95% CI, 3.45-9.13), and NO_X (aHR, 4.80; 95% CI, 3.00-7.66) than among with those with a low genetic risk and low exposure to air pollutants.

IN PRACTICE:

“Findings can inform the development of stricter air quality regulations to mitigate exposure to harmful pollutants, thereby reducing the risk of SLE,” the authors wrote. 

SOURCE:

The study was led by Meiqi Xing, MASc, Huazhong University of Science and Technology, Wuhan, China. It was published online in Arthritis & Rheumatology.

LIMITATIONS:

The study participants were enrolled voluntarily, which may have led to selection bias because they might have been healthier or more health conscious. The study did not consider the specific components of air pollutants, particularly particulate matter, which may have varying effects on the incidence of SLE. Other air pollutants such as ozone, sulfur dioxide, and carbon monoxide were not included in the analysis.

DISCLOSURES:

This study did not disclose any funding source. The authors declared no conflicts of interest.

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

TOPLINE:

Chronic exposure to air pollutants such as fine particulate matter ≤ 2.5 μm in diameter (PM_2.5), particulate matter ≤ 10 μm in diameter (PM₁₀), nitrogen dioxide (NO₂), and nitrogen oxides (NO_X) increased the risk for systemic lupus erythematosus (SLE) onset. The risk was highest among those with high genetic risk and high air-pollution exposure. 

METHODOLOGY:

• Researchers prospectively investigated the association between long-term exposure to air pollutants and incident SLE in 459,815 participants from the UK Biobank.
• A land-use regression model was used to quantify the annual average air pollution concentrations, including PM_2.5, PM₁₀, NO₂, and NO_X.
• The genetic susceptibility to lupus was assessed using polygenic risk scores (PRS), and the participants were classified into low–, intermediate–, or high–genetic-risk groups based on the tertiles of PRS.
• The joint effect of air pollutants and genetic susceptibility to lupus on the risk for incident SLE was evaluated, with the reference group consisting of participants with a low genetic risk and low exposure to air pollution.

TAKEAWAY: 

• Over a median follow-up period of 11.77 years, 399 new cases of SLE were identified.
• The odds of developing SLE were higher among participants with high genetic risk than among those with low genetic risk (hazard ratio [HR], 3.45; P < .001 for trend).
• The risk for developing SLE was even higher among participants with a high genetic risk and high exposure to PM_2.5 (adjusted HR [aHR], 4.16; 95% CI, 2.67-6.49), PM₁₀ (aHR, 5.31; 95% CI, 3.30-8.55), NO₂ (aHR, 5.61; 95% CI, 3.45-9.13), and NO_X (aHR, 4.80; 95% CI, 3.00-7.66) than among with those with a low genetic risk and low exposure to air pollutants.

IN PRACTICE:

“Findings can inform the development of stricter air quality regulations to mitigate exposure to harmful pollutants, thereby reducing the risk of SLE,” the authors wrote. 

SOURCE:

The study was led by Meiqi Xing, MASc, Huazhong University of Science and Technology, Wuhan, China. It was published online in Arthritis & Rheumatology.

LIMITATIONS:

The study participants were enrolled voluntarily, which may have led to selection bias because they might have been healthier or more health conscious. The study did not consider the specific components of air pollutants, particularly particulate matter, which may have varying effects on the incidence of SLE. Other air pollutants such as ozone, sulfur dioxide, and carbon monoxide were not included in the analysis.

DISCLOSURES:

This study did not disclose any funding source. The authors declared no conflicts of interest.

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

TOPLINE:

Chronic exposure to air pollutants such as fine particulate matter ≤ 2.5 μm in diameter (PM_2.5), particulate matter ≤ 10 μm in diameter (PM₁₀), nitrogen dioxide (NO₂), and nitrogen oxides (NO_X) increased the risk for systemic lupus erythematosus (SLE) onset. The risk was highest among those with high genetic risk and high air-pollution exposure. 

METHODOLOGY:

• Researchers prospectively investigated the association between long-term exposure to air pollutants and incident SLE in 459,815 participants from the UK Biobank.
• A land-use regression model was used to quantify the annual average air pollution concentrations, including PM_2.5, PM₁₀, NO₂, and NO_X.
• The genetic susceptibility to lupus was assessed using polygenic risk scores (PRS), and the participants were classified into low–, intermediate–, or high–genetic-risk groups based on the tertiles of PRS.
• The joint effect of air pollutants and genetic susceptibility to lupus on the risk for incident SLE was evaluated, with the reference group consisting of participants with a low genetic risk and low exposure to air pollution.

TAKEAWAY: 

• Over a median follow-up period of 11.77 years, 399 new cases of SLE were identified.
• The odds of developing SLE were higher among participants with high genetic risk than among those with low genetic risk (hazard ratio [HR], 3.45; P < .001 for trend).
• The risk for developing SLE was even higher among participants with a high genetic risk and high exposure to PM_2.5 (adjusted HR [aHR], 4.16; 95% CI, 2.67-6.49), PM₁₀ (aHR, 5.31; 95% CI, 3.30-8.55), NO₂ (aHR, 5.61; 95% CI, 3.45-9.13), and NO_X (aHR, 4.80; 95% CI, 3.00-7.66) than among with those with a low genetic risk and low exposure to air pollutants.

IN PRACTICE:

“Findings can inform the development of stricter air quality regulations to mitigate exposure to harmful pollutants, thereby reducing the risk of SLE,” the authors wrote. 

SOURCE:

The study was led by Meiqi Xing, MASc, Huazhong University of Science and Technology, Wuhan, China. It was published online in Arthritis & Rheumatology.

LIMITATIONS:

The study participants were enrolled voluntarily, which may have led to selection bias because they might have been healthier or more health conscious. The study did not consider the specific components of air pollutants, particularly particulate matter, which may have varying effects on the incidence of SLE. Other air pollutants such as ozone, sulfur dioxide, and carbon monoxide were not included in the analysis.

DISCLOSURES:

This study did not disclose any funding source. The authors declared no conflicts of interest.

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

Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.

Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.

“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.

The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.

Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”

Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute, “consumers take a huge risk when they seek to procure semaglutide outside of a legitimate physician-patient relationship and should only get semaglutide from a licensed and authorized pharmacy after discussing the risks versus benefits with their provider.”

He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
 

Buyer Beware: Online Semaglutide Purchases Not as They Seem

The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.

Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.

The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.

Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”

Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.

At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.

Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”

The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
 

A version of this article appeared on Medscape.com.

Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.

Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.

“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.

The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.

Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”

Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute, “consumers take a huge risk when they seek to procure semaglutide outside of a legitimate physician-patient relationship and should only get semaglutide from a licensed and authorized pharmacy after discussing the risks versus benefits with their provider.”

He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
 

Buyer Beware: Online Semaglutide Purchases Not as They Seem

The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.

Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.

The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.

Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”

Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.

At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.

Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”

The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
 

A version of this article appeared on Medscape.com.

Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.

Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.

“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.

The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.

Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”

Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute, “consumers take a huge risk when they seek to procure semaglutide outside of a legitimate physician-patient relationship and should only get semaglutide from a licensed and authorized pharmacy after discussing the risks versus benefits with their provider.”

He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
 

Buyer Beware: Online Semaglutide Purchases Not as They Seem

The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.

Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.

The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.

Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”

Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.

At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.

Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”

The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
 

A version of this article appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals. 

“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. 

The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.

The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added. 

The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.

REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. Each percent increase in REM sleep was associated with a reduced incidence of atrial fibrillation (odds ratio [OR], 0.86), atrial flutter (OR, 0.78), and sinoatrial node dysfunction/bradycardia (OR, 0.72). A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94). 

Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27). 

The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001). 

The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
 

Findings Support Need for Sleep Consistency 

“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said. 

The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said. 

“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.

As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain. 

Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
 

Device Data Will Evolve to Inform Patient Care

“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study. 

The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.

“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.

“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.

The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.

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

This transcript has been edited for clarity. 

If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it. 

Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.

But if you’ve been looking a bit deeper than the headline-grabbing stories, reading some of the case reports or listening to your patients, you’ll start to wonder whether Ozempic is doing something more. In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories. 

A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.

A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered. 

If only they could stop people from smoking. 

Oh, wait — they can.

At least it seems they can, based on a new study appearing in Annals of Internal Medicine. 

Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation. 

Nicotine and Tobacco Research

Dr. Wilson

Dr. Wilson

Annals of Internal Medicine

Dr. Wilson

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

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

This transcript has been edited for clarity. 

If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it. 

Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.

But if you’ve been looking a bit deeper than the headline-grabbing stories, reading some of the case reports or listening to your patients, you’ll start to wonder whether Ozempic is doing something more. In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories. 

A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.

A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered. 

If only they could stop people from smoking. 

Oh, wait — they can.

At least it seems they can, based on a new study appearing in Annals of Internal Medicine. 

Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation. 

Nicotine and Tobacco Research

Dr. Wilson

Dr. Wilson

Annals of Internal Medicine

Dr. Wilson

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

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

This transcript has been edited for clarity. 

If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it. 

Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.

But if you’ve been looking a bit deeper than the headline-grabbing stories, reading some of the case reports or listening to your patients, you’ll start to wonder whether Ozempic is doing something more. In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories. 

A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.

A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered. 

If only they could stop people from smoking. 

Oh, wait — they can.

At least it seems they can, based on a new study appearing in Annals of Internal Medicine. 

Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation. 

Nicotine and Tobacco Research

Dr. Wilson

Dr. Wilson

Annals of Internal Medicine

Dr. Wilson

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

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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

Approximately half of adults with idiopathic pulmonary arterial hypertension (IPAH) had nonplexiform vasculopathy characterized in part by severe pulmonary microvascular remodeling, based on data from 50 individuals.

The clinical phenotype of IPAH was historically described as a rapidly progressive rare disease in young women and characterized by plexiform lesions, wrote Esther J. Nossent, MD, of Amsterdam University Medical Centers, Amsterdam, the Netherlands, and colleagues. However, the patient population with IPAH has become older and predominantly men, and the nature of vascular phenotypes and histologic patterns in patients with contemporary IPAH has not been well studied, the researchers said.

In a cross-sectional study published in CHEST, the researchers reviewed lung histology data from 50 adults with IPAH that had been assessed by two experienced pathologists. The mean age of the patients was 52 years and 58% were women. Based on a histopathologic evaluation, 24 patients had nonplexiform vasculopathy (48%) and 26 had plexiform vasculopathy (52%). Notably, microvascular remodeling involving arterioles and venules was substantial in patients with nonplexiform vasculopathy but mild or absent in those with plexiform vasculopathy, the researchers wrote.

The researchers also compared the clinical characteristics of patients with plexiform vs nonplexiform vasculopathy. Hemodynamic parameters were similar in both patient groups. However, those with nonplexiform vasculopathy were significantly older than those with plexiform vasculopathy (60 years vs 44 years), were more likely to be men (67% vs 20%), and had a lower diffusing capacity of the lungs for carbon monoxide (DLCO) at diagnosis (all P < .001). Patients with nonplexiform vasculopathy also were significantly more likely than those with plexiform vasculopathy to have a history of smoking (P = .03). Genetic testing revealed no mutations in established PAH genes in the nonplexiform group.

Low DLCO has been associated with worse outcomes regardless of hemodynamic response, the researchers noted. In the current study, “a DLCO of < 45% almost perfectly identified patients with nonplexiform vasculopathy with prominent pulmonary microvascular disease,” they said.

The findings were limited by several factors, including the small study population and the higher frequency of surgical lung biopsies in the nonplexiform group vs the plexiform group, which is not part of the general workup of patients with IPAH, the researchers noted.

More research is needed to better define the subgroup of patients with IPAH with nonplexiform vasculopathy and to identify the causes, biological features, and treatment approaches for these patients, they said. However, the results suggest that differences between patients with IPAH with plexiform vasculopathy and those with nonplexiform vasculopathy could ultimately inform targeted treatment strategies.

“Recognizing these clinical phenotypes allows revisiting current datasets to understand better the potential future clinical consequences of the vascular phenotypes for treatment response and clinical outcome,” the researchers concluded.
 

Findings May Inform More Targeted Therapy

“Any investigation that adds substantive insight into a complex disease that can translate into a better understanding of clinical patient phenotypes and eventually into improved treatments and patient outcomes has relevance at any time,” Paul Forfia, MD, professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, said in an interview.

“There is focus on the antiproliferative forms of pulmonary arterial hypertension–specific therapy, and the results of the current study may have implications to these therapies,” said Dr. Forfia, who was not involved in the current study.

“In the current study, the investigators show that 48% of patients that were traditionally categorized as IPAH had a vascular phenotype that is not considered ‘typical’ or classic for IPAH,” Dr. Forfia told this news organization. “These findings highlight a significant heterogeneity of the pulmonary vascular phenotype within IPAH, which raises the question of whether the nonplexiform patient would be less responsive to the novel, antiproliferative forms of therapy,” he said.

The new findings are quite interesting but not surprising, Dr. Forfia said. “The World Symposia diagnostic groupings for pulmonary hypertension are a very important and necessary form of categorization and differentiation amongst forms of PH [pulmonary hypertension], and these groupings make a best attempt based on available evidence to separate patients of varying PH pathophysiology, both in terms of diagnosis and in how PH patients are treated,” he explained.

“However, clinical experts in PH have known that subphenotypes of PH pathophysiology exist within group I PAH, as well as in PH related to left heart disease (group 2), chronic respiratory disease (group 3), and chronic thromboembolic disease (group 4),” he said.

Findings from the current study reinforce the importance of clinical and physiological phenotyping of each patient, which can help in terms of therapy selection and in managing expectations in response to therapy, Dr. Forfia added.

“Perhaps the most evident and important clinical implication from the current study is to remind clinicians treating patients with PH that heterogeneity exists within the vascular phenotype and clinical makeup of patients even within the same type of PAH,” Dr. Forfia said. “With this insight, clinicians are more informed and thus more apt to consider nuances in the diagnosis, treatment, and expectations for treatment response within PAH,” he said.

Dr. Forfia also highlighted the potential implications of the association between cigarette smoking and the nonplexiform vascular phenotype. “This association was present in the absence of radiographic evidence of emphysema and raises the provocative notion that cigarette smoking may lead to pulmonary vascular abnormalities, perhaps even PAH, in patients without a diagnosis of emphysema,” he said.

“An important limitation from the current study is that the vascular phenotypes observed within their cohort of IPAH patients were obtained from histopathology specimens at the time of autopsy, explant at the time of lung transplantation, and surgical lung biopsy spanning over a 22-year period,” Dr. Forfia noted. Additional research is needed to explore how vascular phenotypic differences can be appreciated in the absence of histopathology and how these differences could impact therapy selection and patient outcomes, he said.

The study received no outside funding. Dr. Nossent disclosed receiving speaker fees from Janssen, MSD, and United Therapeutics/Ferrer and consulting fees from Janssen and United Therapeutics/Ferrer. Dr. Forfia had no financial conflicts to disclose.

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