Cardiology News

Compared with traditional replacement valves, sutureless valves placed through minimally invasive cardiac surgery have less data supporting their use but offer unique features that might make them the preferred option for certain patients, reported specialists.

Two valves placed by minimally invasive surgery received regulatory approval 8 years ago, but they are not widely used to this day.

The sutureless device known as Perceval (Corcym) and a rapidly deployed device called Intuity (Edwards Lifesciences) are used as an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). But despite being commercially available since 2016, the devices are still not being used much.

The devices are not discussed in substantial detail in either the joint guidelines from the American College of Cardiology and American Heart Association issued in 2020 or guidelines from the European Society of Cardiology issued in 2022.

Cristiano Spadaccio, MD, PhD, a cardiothoracic surgeon associated with Lancashire Cardiac Centre in Blackpool, England, and his colleagues reviewed the small number of studies evaluating the alternate approach to “make the cardiology world aware” of alternatives “that can relieve the surgical burden by minimizing the implantation time and length of the operation,” he said.

The comprehensive review is published in the Journal of the American College of Cardiology.
 

A Neglected Alternative

The sutureless Perceval device is held in place by a stent frame that self-expands. The Intuity device also relies primarily on its framework to anchor the valve in place but does involve three sutures. Both devices are still referred to as sutureless in the new review of them.

Only a small number of centers perform minimally invasive cardiac surgeries, and the main advantage of the devices — rapid deployment — has been eroded with the advent of automated knotting which has significantly reduced the time to implant and sutured valve.

The underuse of these devices is largely caused by the limited amount of comparative and prospective data, said Dr. Spadaccio. “The entire literature on sutureless aortic valve replacement with the exception of one randomized controlled trial is observational.”

That trial, PERSIST-AVR, found that the sutureless valves were just as good as conventional ones when it comes to major adverse cardiovascular events including all-cause death, myocardial infarction, stroke, or valve reintervention at 1 year.

In a subanalysis limited to patients who had isolated aortic valve replacement, the sutureless procedure was associated with lower adverse events (5.2% vs 10.8%) at the cost of a higher rate of pacemaker implantation (11% vs 1.6%).

There are also multiple retrospective studies and registries that have generated observational data comparing sutureless aortic valve replacement with SAVR and TAVR in various patient populations, said Dr. Spadaccio, and the review was based on more than a dozen studies published since 2015. Long-term follow-up data for sutureless aortic valve replacements, which now exceeds 10 years, suggest rates of structural valve deterioration and reintervention have been acceptably low.

The minimally invasive procedures have other advantages too. For example, relative to the greater trauma associated with open heart surgery, minimally invasive surgeries typically involve faster recovery, an advantage likely to appeal to many patients who are candidates for either.
 

Quicker Recovery

Collectively, these data suggest that sutureless aortic valve replacement might be a reasonable or even a more appropriate alternative to either SAVR or TAVR when considering specific patient characteristics and goals, according to the review, which included an algorithm identifying specifically where sutureless aortic valve replacement fits with SAVR and TAVR.

“The algorithm is based on different clinical scenarios and reflects current guidelines for SAVR,” said Dr. Spadaccio. For example, current guidelines identify SAVR as preferred in patients younger than 65 years and in older patients with a low Society of Thoracic Surgeons (STS) score, but there are many instances in which sutureless aortic valve replacement might be more attractive, such as in those also undergoing mitral valve repair, coronary artery bypass grafting, or another surgical procedure.

Dr. Spadaccio said that the STS score should not be considered in isolation when evaluating a patient for SAVR or TAVR. Other features such as mobility, frailty score, and comorbid liver or renal disease should also be considered when discussing the three options with patients. As a result, the algorithm emphasizes a detailed evaluation of patient characteristics in selecting one procedure over another.

“The treatment should be really tailored on the individual patient basis,” said Dr. Spadaccio.

Dr. Spadaccio acknowledged that there is a need for more comparative trials, particularly in regard to sutureless aortic valve replacement as an alternative to TAVR. “I really think that a 1:1 RCT on sutureless aortic valve replacement vs TAVR could give better answers to all of these interrogatives.”

But despite the limitations outlined in this review, Dr. Spadaccio and colleagues challenged the perception that current data are not sufficient to allow clinicians to consider sutureless aortic valve replacement in the mix of options.
 

A Viable Option

This comprehensive summary of what is known about sutureless aortic valve replacement compared with the other options addresses an important knowledge gap, said S. Chris Malaisrie, MD, a cardiac surgeon at Northwestern University Feinberg School of Medicine, Chicago, Illinois.

He said he agrees this option has unique qualities. “Minimally invasive surgery has been largely ignored by guideline writers, but patients certainly demand options that are less invasive than standard open heart surgery. Sutureless and rapid deployment valves facilitate minimally invasive surgery and offer an advantageous option for younger patients.”

Dr. Malaisrie said the review is generating discussion about a potentially valuable option within the cardiology community. And that is exactly what Dr. Spadaccio was hoping for. “This paper was meant to educate as much as possible on these details to assist and inform decision-making,” he said.

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

Compared with traditional replacement valves, sutureless valves placed through minimally invasive cardiac surgery have less data supporting their use but offer unique features that might make them the preferred option for certain patients, reported specialists.

Two valves placed by minimally invasive surgery received regulatory approval 8 years ago, but they are not widely used to this day.

The sutureless device known as Perceval (Corcym) and a rapidly deployed device called Intuity (Edwards Lifesciences) are used as an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). But despite being commercially available since 2016, the devices are still not being used much.

The devices are not discussed in substantial detail in either the joint guidelines from the American College of Cardiology and American Heart Association issued in 2020 or guidelines from the European Society of Cardiology issued in 2022.

Cristiano Spadaccio, MD, PhD, a cardiothoracic surgeon associated with Lancashire Cardiac Centre in Blackpool, England, and his colleagues reviewed the small number of studies evaluating the alternate approach to “make the cardiology world aware” of alternatives “that can relieve the surgical burden by minimizing the implantation time and length of the operation,” he said.

The comprehensive review is published in the Journal of the American College of Cardiology.
 

A Neglected Alternative

The sutureless Perceval device is held in place by a stent frame that self-expands. The Intuity device also relies primarily on its framework to anchor the valve in place but does involve three sutures. Both devices are still referred to as sutureless in the new review of them.

Only a small number of centers perform minimally invasive cardiac surgeries, and the main advantage of the devices — rapid deployment — has been eroded with the advent of automated knotting which has significantly reduced the time to implant and sutured valve.

The underuse of these devices is largely caused by the limited amount of comparative and prospective data, said Dr. Spadaccio. “The entire literature on sutureless aortic valve replacement with the exception of one randomized controlled trial is observational.”

That trial, PERSIST-AVR, found that the sutureless valves were just as good as conventional ones when it comes to major adverse cardiovascular events including all-cause death, myocardial infarction, stroke, or valve reintervention at 1 year.

In a subanalysis limited to patients who had isolated aortic valve replacement, the sutureless procedure was associated with lower adverse events (5.2% vs 10.8%) at the cost of a higher rate of pacemaker implantation (11% vs 1.6%).

There are also multiple retrospective studies and registries that have generated observational data comparing sutureless aortic valve replacement with SAVR and TAVR in various patient populations, said Dr. Spadaccio, and the review was based on more than a dozen studies published since 2015. Long-term follow-up data for sutureless aortic valve replacements, which now exceeds 10 years, suggest rates of structural valve deterioration and reintervention have been acceptably low.

The minimally invasive procedures have other advantages too. For example, relative to the greater trauma associated with open heart surgery, minimally invasive surgeries typically involve faster recovery, an advantage likely to appeal to many patients who are candidates for either.
 

Quicker Recovery

Collectively, these data suggest that sutureless aortic valve replacement might be a reasonable or even a more appropriate alternative to either SAVR or TAVR when considering specific patient characteristics and goals, according to the review, which included an algorithm identifying specifically where sutureless aortic valve replacement fits with SAVR and TAVR.

“The algorithm is based on different clinical scenarios and reflects current guidelines for SAVR,” said Dr. Spadaccio. For example, current guidelines identify SAVR as preferred in patients younger than 65 years and in older patients with a low Society of Thoracic Surgeons (STS) score, but there are many instances in which sutureless aortic valve replacement might be more attractive, such as in those also undergoing mitral valve repair, coronary artery bypass grafting, or another surgical procedure.

Dr. Spadaccio said that the STS score should not be considered in isolation when evaluating a patient for SAVR or TAVR. Other features such as mobility, frailty score, and comorbid liver or renal disease should also be considered when discussing the three options with patients. As a result, the algorithm emphasizes a detailed evaluation of patient characteristics in selecting one procedure over another.

“The treatment should be really tailored on the individual patient basis,” said Dr. Spadaccio.

Dr. Spadaccio acknowledged that there is a need for more comparative trials, particularly in regard to sutureless aortic valve replacement as an alternative to TAVR. “I really think that a 1:1 RCT on sutureless aortic valve replacement vs TAVR could give better answers to all of these interrogatives.”

But despite the limitations outlined in this review, Dr. Spadaccio and colleagues challenged the perception that current data are not sufficient to allow clinicians to consider sutureless aortic valve replacement in the mix of options.
 

A Viable Option

This comprehensive summary of what is known about sutureless aortic valve replacement compared with the other options addresses an important knowledge gap, said S. Chris Malaisrie, MD, a cardiac surgeon at Northwestern University Feinberg School of Medicine, Chicago, Illinois.

He said he agrees this option has unique qualities. “Minimally invasive surgery has been largely ignored by guideline writers, but patients certainly demand options that are less invasive than standard open heart surgery. Sutureless and rapid deployment valves facilitate minimally invasive surgery and offer an advantageous option for younger patients.”

Dr. Malaisrie said the review is generating discussion about a potentially valuable option within the cardiology community. And that is exactly what Dr. Spadaccio was hoping for. “This paper was meant to educate as much as possible on these details to assist and inform decision-making,” he said.

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

Compared with traditional replacement valves, sutureless valves placed through minimally invasive cardiac surgery have less data supporting their use but offer unique features that might make them the preferred option for certain patients, reported specialists.

Two valves placed by minimally invasive surgery received regulatory approval 8 years ago, but they are not widely used to this day.

The sutureless device known as Perceval (Corcym) and a rapidly deployed device called Intuity (Edwards Lifesciences) are used as an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). But despite being commercially available since 2016, the devices are still not being used much.

The devices are not discussed in substantial detail in either the joint guidelines from the American College of Cardiology and American Heart Association issued in 2020 or guidelines from the European Society of Cardiology issued in 2022.

Cristiano Spadaccio, MD, PhD, a cardiothoracic surgeon associated with Lancashire Cardiac Centre in Blackpool, England, and his colleagues reviewed the small number of studies evaluating the alternate approach to “make the cardiology world aware” of alternatives “that can relieve the surgical burden by minimizing the implantation time and length of the operation,” he said.

The comprehensive review is published in the Journal of the American College of Cardiology.
 

A Neglected Alternative

The sutureless Perceval device is held in place by a stent frame that self-expands. The Intuity device also relies primarily on its framework to anchor the valve in place but does involve three sutures. Both devices are still referred to as sutureless in the new review of them.

Only a small number of centers perform minimally invasive cardiac surgeries, and the main advantage of the devices — rapid deployment — has been eroded with the advent of automated knotting which has significantly reduced the time to implant and sutured valve.

The underuse of these devices is largely caused by the limited amount of comparative and prospective data, said Dr. Spadaccio. “The entire literature on sutureless aortic valve replacement with the exception of one randomized controlled trial is observational.”

That trial, PERSIST-AVR, found that the sutureless valves were just as good as conventional ones when it comes to major adverse cardiovascular events including all-cause death, myocardial infarction, stroke, or valve reintervention at 1 year.

In a subanalysis limited to patients who had isolated aortic valve replacement, the sutureless procedure was associated with lower adverse events (5.2% vs 10.8%) at the cost of a higher rate of pacemaker implantation (11% vs 1.6%).

There are also multiple retrospective studies and registries that have generated observational data comparing sutureless aortic valve replacement with SAVR and TAVR in various patient populations, said Dr. Spadaccio, and the review was based on more than a dozen studies published since 2015. Long-term follow-up data for sutureless aortic valve replacements, which now exceeds 10 years, suggest rates of structural valve deterioration and reintervention have been acceptably low.

The minimally invasive procedures have other advantages too. For example, relative to the greater trauma associated with open heart surgery, minimally invasive surgeries typically involve faster recovery, an advantage likely to appeal to many patients who are candidates for either.
 

Quicker Recovery

Collectively, these data suggest that sutureless aortic valve replacement might be a reasonable or even a more appropriate alternative to either SAVR or TAVR when considering specific patient characteristics and goals, according to the review, which included an algorithm identifying specifically where sutureless aortic valve replacement fits with SAVR and TAVR.

“The algorithm is based on different clinical scenarios and reflects current guidelines for SAVR,” said Dr. Spadaccio. For example, current guidelines identify SAVR as preferred in patients younger than 65 years and in older patients with a low Society of Thoracic Surgeons (STS) score, but there are many instances in which sutureless aortic valve replacement might be more attractive, such as in those also undergoing mitral valve repair, coronary artery bypass grafting, or another surgical procedure.

Dr. Spadaccio said that the STS score should not be considered in isolation when evaluating a patient for SAVR or TAVR. Other features such as mobility, frailty score, and comorbid liver or renal disease should also be considered when discussing the three options with patients. As a result, the algorithm emphasizes a detailed evaluation of patient characteristics in selecting one procedure over another.

“The treatment should be really tailored on the individual patient basis,” said Dr. Spadaccio.

Dr. Spadaccio acknowledged that there is a need for more comparative trials, particularly in regard to sutureless aortic valve replacement as an alternative to TAVR. “I really think that a 1:1 RCT on sutureless aortic valve replacement vs TAVR could give better answers to all of these interrogatives.”

But despite the limitations outlined in this review, Dr. Spadaccio and colleagues challenged the perception that current data are not sufficient to allow clinicians to consider sutureless aortic valve replacement in the mix of options.
 

A Viable Option

This comprehensive summary of what is known about sutureless aortic valve replacement compared with the other options addresses an important knowledge gap, said S. Chris Malaisrie, MD, a cardiac surgeon at Northwestern University Feinberg School of Medicine, Chicago, Illinois.

He said he agrees this option has unique qualities. “Minimally invasive surgery has been largely ignored by guideline writers, but patients certainly demand options that are less invasive than standard open heart surgery. Sutureless and rapid deployment valves facilitate minimally invasive surgery and offer an advantageous option for younger patients.”

Dr. Malaisrie said the review is generating discussion about a potentially valuable option within the cardiology community. And that is exactly what Dr. Spadaccio was hoping for. “This paper was meant to educate as much as possible on these details to assist and inform decision-making,” he said.

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

High blood pressure is an established risk factor for neurodegeneration and cognitive decline. Long-standing evidence shows that treating hypertension can reduce its vascular consequences, but whether that is true for neurodegeneration is less clear.

Valentin Fuster, MD, president of Mount Sinai Fuster Heart Hospital in New York City, told this news organization. “There is no question in the literature that untreated high blood pressure may lead to dementia,” he said. “The open question is whether treating blood pressure is sufficient to decrease or stop the progress of dementia.”

Studies are mixed, but recent research suggests that addressing hypertension does affect the risk for dementia. A secondary analysis of the China Rural Hypertension Control Project reported at the American Heart Association (AHA) Scientific Sessions in 2023 but not yet published showed that the 4-year blood pressure–lowering program in adults aged 40 or older significantly reduced the risk for all-cause dementia and cognitive impairment.

Similarly, a post hoc analysis of the SPRINT MIND trial found that participants aged 50 or older who underwent intensive (< 120 mm Hg) vs standard (< 140 mm Hg) blood pressure lowering had a lower rate of probable dementia or mild cognitive impairment.

Other studies pointing to a benefit included a pooled individual participant analysis of five randomized controlled trials, which found class I evidence to support antihypertensive treatment to reduce the risk for incident dementia, and an earlier systematic review and meta-analysis of the association of blood pressure lowering with newly diagnosed dementia or cognitive impairment.
 

How It Might Work

Some possible mechanisms underlying the connection have emerged.

“Vascular disease caused by hypertension is clearly implicated in one form of dementia, called vascular cognitive impairment and dementia,” Andrew Moran, MD, PhD, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons in New York City, told this news organization. “This category includes dementia following a stroke caused by uncontrolled hypertension.” 

“At the same time, we now know that hypertension and other vascular risk factors can also contribute, along with other factors, to developing Alzheimer dementia,” he said. “Even without causing clinically evident stroke, vascular disease from hypertension can lead to subtle damage to the brain via ischemia, microhemorrhage, and atrophy.”

“It is well known that hypertension affects the vasculature, and the vasculature of the brain is not spared,” agreed Eileen Handberg, PhD, ARNP, a member of the Hypertension Workgroup at the American College of Cardiology (ACC) and a professor of medicine and director of the Cardiovascular Clinical Trials Program in the University of Florida, Gainesville, Florida. “Combine this with other mechanisms like inflammation and endothelial dysfunction, and add amyloid accumulation, and there is a deterioration in vascular beds leading to decreased cerebral blood flow,” she said.

Treating hypertension likely helps lower dementia risk through “a combination of reduced risk of stroke and also benefits on blood flow, blood vessel health, and reduction in neurodegeneration,” suggested Mitchell S.V. Elkind, MD, chief clinical science officer and past president of the AHA and a professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City. “Midlife blood pressure elevations are associated with deposition of amyloid in the brain, so controlling blood pressure may reduce amyloid deposits and neurodegeneration.”
 

Time in Range or Treat to Target?

With respect to dementia risk, does treating hypertension to a specific target make a difference, or is it the time spent in a healthy blood pressure range? 

“Observational studies and a post hoc analysis of the SPRINT MIND trial suggest that more time spent in a healthy blood pressure range or more stable blood pressure are associated with lower dementia risk,” Dr. Moran said. Citing results of the CHRC program and SPRINT MIND trial, he suggested that while a dose-response effect (the lower the blood pressure, the lower the dementia risk) hasn’t been definitively demonstrated, it is likely the case.

In his practice, Dr. Moran follows ACC/AHA guidelines and prescribes antihypertensives to get blood pressure below 130/80 mm Hg in individuals with hypertension who have other high-risk factors (cardiovascular disease, diabetes, chronic kidney disease, or high risk for these conditions). “The treatment rule for people with hypertension without these other risk factors is less clear — lowering blood pressure below 140/90 mm Hg is a must; I will discuss with patients whether to go lower than that.”

“The relative contributions of time in range versus treating to a target for blood pressure require further study,” said Dr. Elkind. “It is likely that the cumulative effect of blood pressure over time has a big role to play — and it does seem clear that midlife blood pressure is even more important than blood pressure late in life.”

That said, he added, “In general and all things being equal, I would treat to a blood pressure of < 120/80 mmHg,” given the SPRINT trial findings of greater benefits when treating to this systolic blood pressure goal. “Of course, if patients have side effects such as lightheadedness or dizziness or other medical conditions that require a higher target, then one would need to adjust the treatment targets.”

According to Dr. Fuster, targets should not be the focus because they vary. For example, the ACC/AHA guidelines use < 130/80 mm Hg, whereas the European Society of Hypertension guidelines and those of the American Academy of Family Physicians specify < 140/90 mm Hg and include age-based criteria. Because there are no studies comparing the outcomes of one set of guidelines vs another, Dr. Fuster thinks the focus should be on starting treatment as early as possible to prevent hypertension leading to dementia.

He pointed to the ongoing PESA trial, which uses brain MRI and other tests to characterize longitudinal associations among cerebral glucose metabolism, subclinical atherosclerosis, and cardiovascular risk factors in asymptomatic individuals aged 40-54. Most did not have hypertension at baseline.

A recently published analysis of a subcohort of 370 PESA participants found that those with persistent high cardiovascular risk and subclinical carotid atherosclerosis already had signs of brain metabolic decline, “suggesting that maintenance of cardiovascular health during midlife could contribute to reductions in neurodegenerative disease burden later in life,” wrote the investigators.
 

Is It Ever Too Late?

If starting hypertension treatment in midlife can help reduce the risk for cognitive impairment later, can treating later in life also help? “It’s theoretically possible, but it has to be proven,” Dr. Fuster said. “There are no data on whether there’s less chance to prevent the development of dementia if you start treating hypertension at age 70, for example. And we have no idea whether hypertension treatment will prevent progression in those who already have dementia.”

“Treating high blood pressure in older adults could affect the course of further progressive cognitive decline by improving vascular health and preventing strokes, which likely exacerbate nonvascular dementia,” Dr. Elkind suggested. “Most people with dementia have a combination of vascular and nonvascular dementia, so treating reversible causes wherever possible makes a difference.”

Dr. Elkind treats older patients with this in mind, he said, “even though most of the evidence points to the fact that it is blood pressure in middle age, not older age, that seems to have the biggest impact on later-life cognitive decline and dementia.” Like Dr. Fuster, he said, “the best strategy is to identify and treat blood pressure in midlife, before damage to the brain has advanced.”

Dr. Moran noted, “The latest science on dementia causes suggests it is difficult to draw a border between vascular and nonvascular dementia. So, as a practical matter, healthcare providers should consider that hypertension treatment is one of the best ways to prevent any category of dementia. This dementia prevention is added to the well-known benefits of hypertension treatment to prevent heart attacks, strokes, and kidney disease: ‘Healthy heart, healthy brain.’ ”

“Our BP [blood pressure] control rates overall are still abysmal,” Dr. Handberg added. Currently around one in four US adults with hypertension have it under control. Studies have shown that blood pressure control rates of 70%-80% are achievable, she said. “We can’t let patient or provider inertia continue.”

Dr. Handberg, Dr. Elkind, Dr. Moran, and Dr. Fuster declared no relevant conflicts of interest.

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

High blood pressure is an established risk factor for neurodegeneration and cognitive decline. Long-standing evidence shows that treating hypertension can reduce its vascular consequences, but whether that is true for neurodegeneration is less clear.

Valentin Fuster, MD, president of Mount Sinai Fuster Heart Hospital in New York City, told this news organization. “There is no question in the literature that untreated high blood pressure may lead to dementia,” he said. “The open question is whether treating blood pressure is sufficient to decrease or stop the progress of dementia.”

Studies are mixed, but recent research suggests that addressing hypertension does affect the risk for dementia. A secondary analysis of the China Rural Hypertension Control Project reported at the American Heart Association (AHA) Scientific Sessions in 2023 but not yet published showed that the 4-year blood pressure–lowering program in adults aged 40 or older significantly reduced the risk for all-cause dementia and cognitive impairment.

Similarly, a post hoc analysis of the SPRINT MIND trial found that participants aged 50 or older who underwent intensive (< 120 mm Hg) vs standard (< 140 mm Hg) blood pressure lowering had a lower rate of probable dementia or mild cognitive impairment.

Other studies pointing to a benefit included a pooled individual participant analysis of five randomized controlled trials, which found class I evidence to support antihypertensive treatment to reduce the risk for incident dementia, and an earlier systematic review and meta-analysis of the association of blood pressure lowering with newly diagnosed dementia or cognitive impairment.
 

How It Might Work

Some possible mechanisms underlying the connection have emerged.

“Vascular disease caused by hypertension is clearly implicated in one form of dementia, called vascular cognitive impairment and dementia,” Andrew Moran, MD, PhD, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons in New York City, told this news organization. “This category includes dementia following a stroke caused by uncontrolled hypertension.” 

“At the same time, we now know that hypertension and other vascular risk factors can also contribute, along with other factors, to developing Alzheimer dementia,” he said. “Even without causing clinically evident stroke, vascular disease from hypertension can lead to subtle damage to the brain via ischemia, microhemorrhage, and atrophy.”

“It is well known that hypertension affects the vasculature, and the vasculature of the brain is not spared,” agreed Eileen Handberg, PhD, ARNP, a member of the Hypertension Workgroup at the American College of Cardiology (ACC) and a professor of medicine and director of the Cardiovascular Clinical Trials Program in the University of Florida, Gainesville, Florida. “Combine this with other mechanisms like inflammation and endothelial dysfunction, and add amyloid accumulation, and there is a deterioration in vascular beds leading to decreased cerebral blood flow,” she said.

Treating hypertension likely helps lower dementia risk through “a combination of reduced risk of stroke and also benefits on blood flow, blood vessel health, and reduction in neurodegeneration,” suggested Mitchell S.V. Elkind, MD, chief clinical science officer and past president of the AHA and a professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City. “Midlife blood pressure elevations are associated with deposition of amyloid in the brain, so controlling blood pressure may reduce amyloid deposits and neurodegeneration.”
 

Time in Range or Treat to Target?

With respect to dementia risk, does treating hypertension to a specific target make a difference, or is it the time spent in a healthy blood pressure range? 

“Observational studies and a post hoc analysis of the SPRINT MIND trial suggest that more time spent in a healthy blood pressure range or more stable blood pressure are associated with lower dementia risk,” Dr. Moran said. Citing results of the CHRC program and SPRINT MIND trial, he suggested that while a dose-response effect (the lower the blood pressure, the lower the dementia risk) hasn’t been definitively demonstrated, it is likely the case.

In his practice, Dr. Moran follows ACC/AHA guidelines and prescribes antihypertensives to get blood pressure below 130/80 mm Hg in individuals with hypertension who have other high-risk factors (cardiovascular disease, diabetes, chronic kidney disease, or high risk for these conditions). “The treatment rule for people with hypertension without these other risk factors is less clear — lowering blood pressure below 140/90 mm Hg is a must; I will discuss with patients whether to go lower than that.”

“The relative contributions of time in range versus treating to a target for blood pressure require further study,” said Dr. Elkind. “It is likely that the cumulative effect of blood pressure over time has a big role to play — and it does seem clear that midlife blood pressure is even more important than blood pressure late in life.”

That said, he added, “In general and all things being equal, I would treat to a blood pressure of < 120/80 mmHg,” given the SPRINT trial findings of greater benefits when treating to this systolic blood pressure goal. “Of course, if patients have side effects such as lightheadedness or dizziness or other medical conditions that require a higher target, then one would need to adjust the treatment targets.”

According to Dr. Fuster, targets should not be the focus because they vary. For example, the ACC/AHA guidelines use < 130/80 mm Hg, whereas the European Society of Hypertension guidelines and those of the American Academy of Family Physicians specify < 140/90 mm Hg and include age-based criteria. Because there are no studies comparing the outcomes of one set of guidelines vs another, Dr. Fuster thinks the focus should be on starting treatment as early as possible to prevent hypertension leading to dementia.

He pointed to the ongoing PESA trial, which uses brain MRI and other tests to characterize longitudinal associations among cerebral glucose metabolism, subclinical atherosclerosis, and cardiovascular risk factors in asymptomatic individuals aged 40-54. Most did not have hypertension at baseline.

A recently published analysis of a subcohort of 370 PESA participants found that those with persistent high cardiovascular risk and subclinical carotid atherosclerosis already had signs of brain metabolic decline, “suggesting that maintenance of cardiovascular health during midlife could contribute to reductions in neurodegenerative disease burden later in life,” wrote the investigators.
 

Is It Ever Too Late?

If starting hypertension treatment in midlife can help reduce the risk for cognitive impairment later, can treating later in life also help? “It’s theoretically possible, but it has to be proven,” Dr. Fuster said. “There are no data on whether there’s less chance to prevent the development of dementia if you start treating hypertension at age 70, for example. And we have no idea whether hypertension treatment will prevent progression in those who already have dementia.”

“Treating high blood pressure in older adults could affect the course of further progressive cognitive decline by improving vascular health and preventing strokes, which likely exacerbate nonvascular dementia,” Dr. Elkind suggested. “Most people with dementia have a combination of vascular and nonvascular dementia, so treating reversible causes wherever possible makes a difference.”

Dr. Elkind treats older patients with this in mind, he said, “even though most of the evidence points to the fact that it is blood pressure in middle age, not older age, that seems to have the biggest impact on later-life cognitive decline and dementia.” Like Dr. Fuster, he said, “the best strategy is to identify and treat blood pressure in midlife, before damage to the brain has advanced.”

Dr. Moran noted, “The latest science on dementia causes suggests it is difficult to draw a border between vascular and nonvascular dementia. So, as a practical matter, healthcare providers should consider that hypertension treatment is one of the best ways to prevent any category of dementia. This dementia prevention is added to the well-known benefits of hypertension treatment to prevent heart attacks, strokes, and kidney disease: ‘Healthy heart, healthy brain.’ ”

“Our BP [blood pressure] control rates overall are still abysmal,” Dr. Handberg added. Currently around one in four US adults with hypertension have it under control. Studies have shown that blood pressure control rates of 70%-80% are achievable, she said. “We can’t let patient or provider inertia continue.”

Dr. Handberg, Dr. Elkind, Dr. Moran, and Dr. Fuster declared no relevant conflicts of interest.

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

High blood pressure is an established risk factor for neurodegeneration and cognitive decline. Long-standing evidence shows that treating hypertension can reduce its vascular consequences, but whether that is true for neurodegeneration is less clear.

Valentin Fuster, MD, president of Mount Sinai Fuster Heart Hospital in New York City, told this news organization. “There is no question in the literature that untreated high blood pressure may lead to dementia,” he said. “The open question is whether treating blood pressure is sufficient to decrease or stop the progress of dementia.”

Studies are mixed, but recent research suggests that addressing hypertension does affect the risk for dementia. A secondary analysis of the China Rural Hypertension Control Project reported at the American Heart Association (AHA) Scientific Sessions in 2023 but not yet published showed that the 4-year blood pressure–lowering program in adults aged 40 or older significantly reduced the risk for all-cause dementia and cognitive impairment.

Similarly, a post hoc analysis of the SPRINT MIND trial found that participants aged 50 or older who underwent intensive (< 120 mm Hg) vs standard (< 140 mm Hg) blood pressure lowering had a lower rate of probable dementia or mild cognitive impairment.

Other studies pointing to a benefit included a pooled individual participant analysis of five randomized controlled trials, which found class I evidence to support antihypertensive treatment to reduce the risk for incident dementia, and an earlier systematic review and meta-analysis of the association of blood pressure lowering with newly diagnosed dementia or cognitive impairment.
 

How It Might Work

Some possible mechanisms underlying the connection have emerged.

“Vascular disease caused by hypertension is clearly implicated in one form of dementia, called vascular cognitive impairment and dementia,” Andrew Moran, MD, PhD, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons in New York City, told this news organization. “This category includes dementia following a stroke caused by uncontrolled hypertension.” 

“At the same time, we now know that hypertension and other vascular risk factors can also contribute, along with other factors, to developing Alzheimer dementia,” he said. “Even without causing clinically evident stroke, vascular disease from hypertension can lead to subtle damage to the brain via ischemia, microhemorrhage, and atrophy.”

“It is well known that hypertension affects the vasculature, and the vasculature of the brain is not spared,” agreed Eileen Handberg, PhD, ARNP, a member of the Hypertension Workgroup at the American College of Cardiology (ACC) and a professor of medicine and director of the Cardiovascular Clinical Trials Program in the University of Florida, Gainesville, Florida. “Combine this with other mechanisms like inflammation and endothelial dysfunction, and add amyloid accumulation, and there is a deterioration in vascular beds leading to decreased cerebral blood flow,” she said.

Treating hypertension likely helps lower dementia risk through “a combination of reduced risk of stroke and also benefits on blood flow, blood vessel health, and reduction in neurodegeneration,” suggested Mitchell S.V. Elkind, MD, chief clinical science officer and past president of the AHA and a professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City. “Midlife blood pressure elevations are associated with deposition of amyloid in the brain, so controlling blood pressure may reduce amyloid deposits and neurodegeneration.”
 

Time in Range or Treat to Target?

With respect to dementia risk, does treating hypertension to a specific target make a difference, or is it the time spent in a healthy blood pressure range? 

“Observational studies and a post hoc analysis of the SPRINT MIND trial suggest that more time spent in a healthy blood pressure range or more stable blood pressure are associated with lower dementia risk,” Dr. Moran said. Citing results of the CHRC program and SPRINT MIND trial, he suggested that while a dose-response effect (the lower the blood pressure, the lower the dementia risk) hasn’t been definitively demonstrated, it is likely the case.

In his practice, Dr. Moran follows ACC/AHA guidelines and prescribes antihypertensives to get blood pressure below 130/80 mm Hg in individuals with hypertension who have other high-risk factors (cardiovascular disease, diabetes, chronic kidney disease, or high risk for these conditions). “The treatment rule for people with hypertension without these other risk factors is less clear — lowering blood pressure below 140/90 mm Hg is a must; I will discuss with patients whether to go lower than that.”

“The relative contributions of time in range versus treating to a target for blood pressure require further study,” said Dr. Elkind. “It is likely that the cumulative effect of blood pressure over time has a big role to play — and it does seem clear that midlife blood pressure is even more important than blood pressure late in life.”

That said, he added, “In general and all things being equal, I would treat to a blood pressure of < 120/80 mmHg,” given the SPRINT trial findings of greater benefits when treating to this systolic blood pressure goal. “Of course, if patients have side effects such as lightheadedness or dizziness or other medical conditions that require a higher target, then one would need to adjust the treatment targets.”

According to Dr. Fuster, targets should not be the focus because they vary. For example, the ACC/AHA guidelines use < 130/80 mm Hg, whereas the European Society of Hypertension guidelines and those of the American Academy of Family Physicians specify < 140/90 mm Hg and include age-based criteria. Because there are no studies comparing the outcomes of one set of guidelines vs another, Dr. Fuster thinks the focus should be on starting treatment as early as possible to prevent hypertension leading to dementia.

He pointed to the ongoing PESA trial, which uses brain MRI and other tests to characterize longitudinal associations among cerebral glucose metabolism, subclinical atherosclerosis, and cardiovascular risk factors in asymptomatic individuals aged 40-54. Most did not have hypertension at baseline.

A recently published analysis of a subcohort of 370 PESA participants found that those with persistent high cardiovascular risk and subclinical carotid atherosclerosis already had signs of brain metabolic decline, “suggesting that maintenance of cardiovascular health during midlife could contribute to reductions in neurodegenerative disease burden later in life,” wrote the investigators.
 

Is It Ever Too Late?

If starting hypertension treatment in midlife can help reduce the risk for cognitive impairment later, can treating later in life also help? “It’s theoretically possible, but it has to be proven,” Dr. Fuster said. “There are no data on whether there’s less chance to prevent the development of dementia if you start treating hypertension at age 70, for example. And we have no idea whether hypertension treatment will prevent progression in those who already have dementia.”

“Treating high blood pressure in older adults could affect the course of further progressive cognitive decline by improving vascular health and preventing strokes, which likely exacerbate nonvascular dementia,” Dr. Elkind suggested. “Most people with dementia have a combination of vascular and nonvascular dementia, so treating reversible causes wherever possible makes a difference.”

Dr. Elkind treats older patients with this in mind, he said, “even though most of the evidence points to the fact that it is blood pressure in middle age, not older age, that seems to have the biggest impact on later-life cognitive decline and dementia.” Like Dr. Fuster, he said, “the best strategy is to identify and treat blood pressure in midlife, before damage to the brain has advanced.”

Dr. Moran noted, “The latest science on dementia causes suggests it is difficult to draw a border between vascular and nonvascular dementia. So, as a practical matter, healthcare providers should consider that hypertension treatment is one of the best ways to prevent any category of dementia. This dementia prevention is added to the well-known benefits of hypertension treatment to prevent heart attacks, strokes, and kidney disease: ‘Healthy heart, healthy brain.’ ”

“Our BP [blood pressure] control rates overall are still abysmal,” Dr. Handberg added. Currently around one in four US adults with hypertension have it under control. Studies have shown that blood pressure control rates of 70%-80% are achievable, she said. “We can’t let patient or provider inertia continue.”

Dr. Handberg, Dr. Elkind, Dr. Moran, and Dr. Fuster declared no relevant conflicts of interest.

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

Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

Within the next few years, patients will go to their primary care facility for a medical problem. They’ll be greeted by a nonhuman who speaks in the language of their choice. Based upon the initial interview, which will be taken in note form, the patient will be diagnosed, and a prescription called into the pharmacy. They’ll pay the robot at a reception kiosk, and their meds will be delivered via driverless car.

Or so suggests Allan Stewart, MD, medical director and chief of cardiothoracic surgery at HCA Florida Mercy Hospital in Miami.

The writing is on the wall. Artificial intelligence (AI) is only going to play a more significant role in healthcare, and the entire patient experience will be much different in the next 5 years, he said.

If that sounds far too futuristic, buckle up. AI is already here and being used by most medical specialties. However, it’s primary care that stands to gain the most from this technology — right now — thanks to its ability to radically streamline patient care.
 

Seeing the Doctor and His or Her AI Assistant

AI is making doctors’ work lives easier, whether the technology helps with risk prevention and intervention or closing care gaps. It can also triage patient complaints, monitor patients remotely, or even perform digital health coaching to keep patients on track with their lifestyle regimens or monitor their health conditions.

Each of these AI components enables primary care physicians to reduce some of the paperwork requirements of their jobs and do what they were trained to do — listen and assess patients. Doctors currently spend 12 hours on average each week submitting prior authorization requests, according to an American Medical Association survey.

“Primary care can be overwhelming, especially today, with the advent of electronic records and data,” said Davin Lundquist, MD, a family medicine physician and chief medical officer at Augmedix, an automated medical documentation company that provides tools to reduce clinician burnout. “The amount of data we have to go through to try to get a complete and clear picture of our patients can be overwhelming on top of the referrals, administrative burdens, and regulatory requirements, which seem to be focused on the primary care space,” Dr. Lundquist said.

With an AI assist, primary care physicians can reduce their prep and pre-charting time, lessen the time needed for paperwork outside of clinic hours, and streamline information, including access to lab results, radiology reports, and consults.

“AI is already helping doctors manage their practices, make differential diagnoses, and input progress notes or histories,” said Dr. Stewart.

In Seattle, Ford Parsons, MD, chief of operational analytics at Providence Hospitals in Seattle, has been leading a generative AI project that recently developed a tool called Provaria to prioritize incoming messages from patients. The tool ensures that those with more urgent needs get immediate attention, and it supports the personnel who lead the responses.

The process begins with Provaria reviewing patient messages to ensure those with more urgent needs, such as a mental health crisis, get immediate attention instead of answering messages in the order they were received.

Provaria also provides resources to help responding staff craft a reply. If a patient’s message cites back pain, for example, the system might suggest a referral to a physical therapist, include a link to that department, and prompt the staff to ask about red flags that indicate a more urgent situation.

After an initial rollout, Providence recently deployed Provaria to manage the messages for all 4000 of its primary care, family medicine, and internal medicine providers. The system has reviewed and categorized more than 500,000 messages so far.

“This is another example where AI can increase the human connection in healthcare,” Dr. Parsons said. “That’s the opposite of what others are saying, but by using AI, you can automate the stuff that isn’t critical that doctors have wound up doing.”
 

AI Helps Foster Better Person-to-Person Communication

In recent years, the first thing most doctors do when they enter the exam room with a patient is log into the in-room computer and start to take notes — which can be off-putting to patients.

Now devices can ease this process, such as PLAUD, an AI voice recognition device that attaches to a cell phone. Just the size of a credit card, the device enables conversations to be easily recorded. It not only streamlines note-taking but also enables a physician to listen intently to a patient’s concerns instead of furiously jotting down notes.

“That device is already helping transcribe conversations into notes and then into a patient’s electronic medical record,” Dr. Stewart said. “This helps save doctors the work of having to input patient information.”
 

AI Can’t Be a Compassionate Human

The one thing AI can’t do is show compassion, at least not yet. The someday “vision” when a robot will gather intel about a patient’s symptoms and even offer a diagnosis does have some downsides. There is no replacement for human interaction, especially in the case of dire health news.

“If you have signs of a metastatic cancer and a nonhuman is delivering this news, there’s no way AI can share this news with compassion,” said Dr. Stewart.

For now, AI is becoming instrumental in helping reduce the number of extra demands on primary care doctors, as well as physicians in other specialties, so that they can continue focusing on what matters — healing patients.
 

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

In this article, I will review several recently published articles and guidelines relevant to the care of older adults in primary care. The articles of interest address statins for primary prevention, vitamin D supplementation and testing, and physical activity for healthy aging.
 

Statins for Primary Prevention of Cardiovascular Disease

A common conundrum in primary care is whether an older adult should be on a statin for primary prevention. This question has been difficult to answer because of the underrepresentation of older adults in clinical trials that examine the effect of statins for primary prevention. A recent study by Xu et al. published in Annals of Internal Medicine sought to address this gap in knowledge, investigating the risks and benefits of statins for primary prevention for older adults.¹

This study stratified participants by “old” (aged 75-84 years) and “very old” (85 years or older). In this study, older adults who had an indication for statins were initiated on statins and studied over a 5-year period and compared with age-matched cohorts not initiated on statin therapy. Participants with known cardiovascular disease at baseline were excluded. The outcomes of interest were major cardiovascular disease (CVD) (a composite of myocardial infarction, stroke, or heart failure), all-cause mortality, and adverse effect of drug therapy (myopathy or liver dysfunction).

The study found that among older adults aged 75-84, initiation of statin therapy led to a 1.2% risk reduction in major CVD over a 5-year period. For older adults aged 85 and greater, initiation of statins had an even larger impact, leading to a 4.4% risk reduction in major CVD over a 5-year period. The study found that there was no significant difference in adverse effects including myopathy or liver dysfunction in both age groups.

Statins, the study suggests, are appropriate and safe to initiate for primary prevention in older adults and can lead to substantial benefits in reduction of CVD. While time to benefit was not explicitly examined in this study, a prior study by Yourman et al. suggested that the time to benefit for statins for primary prevention in adults aged 50-75 would be least 2.5 years.²

My takeaway from these findings is to discuss statin initiation for primary prevention for older patients who are focused on longevity, have good functional status (often used in geriatrics as a proxy for prognosis), and are willing to accept more medications.
 

Empiric Vitamin D Supplementation in Adults over 75 Years

Vitamin D is one of the most common supplements taken by older adults but evidence supporting vitamin D supplementation is variable in published literature, as most data comes from observational trials. New guidelines from the Endocrine Society focused on developing recommendations for healthy individuals with data obtained from randomized controlled trials (RCTs) and large longitudinal observational trials with comparison groups if RCTs were not available. These guidelines recommend against empiric supplementation of vitamin D for healthy adults aged 18-74, excluding pregnant women and patients with high-risk diabetes.³

For older adults aged 75 or greater, empiric vitamin D supplementation is recommended because of the possible reduction of risk in all-cause mortality in this population. Of note, this was a grade 2 recommendation by the panel, indicating that the benefits of the treatment probably outweigh the risks. The panel stated that vitamin D supplementation could be delivered through fortified foods, multivitamins with vitamin D, or as a separate vitamin D supplement.

The dosage should remain within the recommended daily allowance outlined by the Institute of Medicine of 800 IU daily for adults over 70, and the panel recommends low-dose daily vitamin D supplementation over high-dose interval supplementation. The panel noted that routine screening of vitamin D levels should not be used to guide decision-making on whether to start supplementation, but vitamin D levels should be obtained for patients who have an indication for evaluation.

The reviewers highlight that these guidelines were developed for healthy individuals and are not applicable to those with conditions that warrant vitamin D evaluation. In my clinical practice, many of my patients have bone-mineral conditions and cognitive impairment that warrant evaluation. Based on these guidelines, I will consider empiric vitamin D supplementation more often for healthy patients aged 75 and older.
 

Sedentary Behaviors and Healthy Aging

Engaging inactive older adults in regular physical activity can be challenging, particularly as the pandemic has led to more pervasive social isolation and affected the availability of in-person exercise activities in the community. Physical activity is a key component of healthy aging and cognition, and its benefits should be a part of routine counseling for older adults.

An interesting recent study published in JAMA Network Open by Shi et al. evaluated the association of health behaviors and aging in female US nurses over a 20-year period.⁴ Surveys were administered to capture time spent in each behavior, such as being sedentary (TV watching, sitting at home or at work), light activity (walking around the house or at work), and moderate to vigorous activity (walking for exercise, lawn mowing). “Healthy aging” was defined by the absence of chronic conditions such as heart failure, and lack of physical, mental, and cognitive impairment.

The study found that participants who were more sedentary were less likely to age healthfully, with each additional 2 hours of TV watching per day associated with a 12% reduction in likelihood of healthy aging. Light physical activity was associated with a significant increase in healthy aging, with a 6% increase in the likelihood of healthy aging for each additional 2 hours of light activity. Each additional 1 hour of moderate to vigorous activity was associated with a 14% increase in the likelihood of healthy aging. These findings support discussions with patients that behavior change, even in small increments, can be beneficial in healthy aging.
 

References

1. Xu W et al. Ann Intern Med. 2024 Jun;177(6):701-10.

2. Yourman LC et al. JAMA Intern Med. 2021;181:179-85.

3. Demay MB et al. J Clin Endocrinol Metab. August 2024;109(8):1907-47.

4. Shi H et al. JAMA Netw Open. 2024;7(6):e2416300.

In this article, I will review several recently published articles and guidelines relevant to the care of older adults in primary care. The articles of interest address statins for primary prevention, vitamin D supplementation and testing, and physical activity for healthy aging.
 

Statins for Primary Prevention of Cardiovascular Disease

A common conundrum in primary care is whether an older adult should be on a statin for primary prevention. This question has been difficult to answer because of the underrepresentation of older adults in clinical trials that examine the effect of statins for primary prevention. A recent study by Xu et al. published in Annals of Internal Medicine sought to address this gap in knowledge, investigating the risks and benefits of statins for primary prevention for older adults.¹

This study stratified participants by “old” (aged 75-84 years) and “very old” (85 years or older). In this study, older adults who had an indication for statins were initiated on statins and studied over a 5-year period and compared with age-matched cohorts not initiated on statin therapy. Participants with known cardiovascular disease at baseline were excluded. The outcomes of interest were major cardiovascular disease (CVD) (a composite of myocardial infarction, stroke, or heart failure), all-cause mortality, and adverse effect of drug therapy (myopathy or liver dysfunction).

The study found that among older adults aged 75-84, initiation of statin therapy led to a 1.2% risk reduction in major CVD over a 5-year period. For older adults aged 85 and greater, initiation of statins had an even larger impact, leading to a 4.4% risk reduction in major CVD over a 5-year period. The study found that there was no significant difference in adverse effects including myopathy or liver dysfunction in both age groups.

Statins, the study suggests, are appropriate and safe to initiate for primary prevention in older adults and can lead to substantial benefits in reduction of CVD. While time to benefit was not explicitly examined in this study, a prior study by Yourman et al. suggested that the time to benefit for statins for primary prevention in adults aged 50-75 would be least 2.5 years.²

My takeaway from these findings is to discuss statin initiation for primary prevention for older patients who are focused on longevity, have good functional status (often used in geriatrics as a proxy for prognosis), and are willing to accept more medications.
 

Empiric Vitamin D Supplementation in Adults over 75 Years

Vitamin D is one of the most common supplements taken by older adults but evidence supporting vitamin D supplementation is variable in published literature, as most data comes from observational trials. New guidelines from the Endocrine Society focused on developing recommendations for healthy individuals with data obtained from randomized controlled trials (RCTs) and large longitudinal observational trials with comparison groups if RCTs were not available. These guidelines recommend against empiric supplementation of vitamin D for healthy adults aged 18-74, excluding pregnant women and patients with high-risk diabetes.³

For older adults aged 75 or greater, empiric vitamin D supplementation is recommended because of the possible reduction of risk in all-cause mortality in this population. Of note, this was a grade 2 recommendation by the panel, indicating that the benefits of the treatment probably outweigh the risks. The panel stated that vitamin D supplementation could be delivered through fortified foods, multivitamins with vitamin D, or as a separate vitamin D supplement.

The dosage should remain within the recommended daily allowance outlined by the Institute of Medicine of 800 IU daily for adults over 70, and the panel recommends low-dose daily vitamin D supplementation over high-dose interval supplementation. The panel noted that routine screening of vitamin D levels should not be used to guide decision-making on whether to start supplementation, but vitamin D levels should be obtained for patients who have an indication for evaluation.

The reviewers highlight that these guidelines were developed for healthy individuals and are not applicable to those with conditions that warrant vitamin D evaluation. In my clinical practice, many of my patients have bone-mineral conditions and cognitive impairment that warrant evaluation. Based on these guidelines, I will consider empiric vitamin D supplementation more often for healthy patients aged 75 and older.
 

Sedentary Behaviors and Healthy Aging

Engaging inactive older adults in regular physical activity can be challenging, particularly as the pandemic has led to more pervasive social isolation and affected the availability of in-person exercise activities in the community. Physical activity is a key component of healthy aging and cognition, and its benefits should be a part of routine counseling for older adults.

An interesting recent study published in JAMA Network Open by Shi et al. evaluated the association of health behaviors and aging in female US nurses over a 20-year period.⁴ Surveys were administered to capture time spent in each behavior, such as being sedentary (TV watching, sitting at home or at work), light activity (walking around the house or at work), and moderate to vigorous activity (walking for exercise, lawn mowing). “Healthy aging” was defined by the absence of chronic conditions such as heart failure, and lack of physical, mental, and cognitive impairment.

The study found that participants who were more sedentary were less likely to age healthfully, with each additional 2 hours of TV watching per day associated with a 12% reduction in likelihood of healthy aging. Light physical activity was associated with a significant increase in healthy aging, with a 6% increase in the likelihood of healthy aging for each additional 2 hours of light activity. Each additional 1 hour of moderate to vigorous activity was associated with a 14% increase in the likelihood of healthy aging. These findings support discussions with patients that behavior change, even in small increments, can be beneficial in healthy aging.
 

References

1. Xu W et al. Ann Intern Med. 2024 Jun;177(6):701-10.

2. Yourman LC et al. JAMA Intern Med. 2021;181:179-85.

3. Demay MB et al. J Clin Endocrinol Metab. August 2024;109(8):1907-47.

4. Shi H et al. JAMA Netw Open. 2024;7(6):e2416300.

In this article, I will review several recently published articles and guidelines relevant to the care of older adults in primary care. The articles of interest address statins for primary prevention, vitamin D supplementation and testing, and physical activity for healthy aging.
 

Statins for Primary Prevention of Cardiovascular Disease

A common conundrum in primary care is whether an older adult should be on a statin for primary prevention. This question has been difficult to answer because of the underrepresentation of older adults in clinical trials that examine the effect of statins for primary prevention. A recent study by Xu et al. published in Annals of Internal Medicine sought to address this gap in knowledge, investigating the risks and benefits of statins for primary prevention for older adults.¹

This study stratified participants by “old” (aged 75-84 years) and “very old” (85 years or older). In this study, older adults who had an indication for statins were initiated on statins and studied over a 5-year period and compared with age-matched cohorts not initiated on statin therapy. Participants with known cardiovascular disease at baseline were excluded. The outcomes of interest were major cardiovascular disease (CVD) (a composite of myocardial infarction, stroke, or heart failure), all-cause mortality, and adverse effect of drug therapy (myopathy or liver dysfunction).

The study found that among older adults aged 75-84, initiation of statin therapy led to a 1.2% risk reduction in major CVD over a 5-year period. For older adults aged 85 and greater, initiation of statins had an even larger impact, leading to a 4.4% risk reduction in major CVD over a 5-year period. The study found that there was no significant difference in adverse effects including myopathy or liver dysfunction in both age groups.

Statins, the study suggests, are appropriate and safe to initiate for primary prevention in older adults and can lead to substantial benefits in reduction of CVD. While time to benefit was not explicitly examined in this study, a prior study by Yourman et al. suggested that the time to benefit for statins for primary prevention in adults aged 50-75 would be least 2.5 years.²

My takeaway from these findings is to discuss statin initiation for primary prevention for older patients who are focused on longevity, have good functional status (often used in geriatrics as a proxy for prognosis), and are willing to accept more medications.
 

Empiric Vitamin D Supplementation in Adults over 75 Years

Vitamin D is one of the most common supplements taken by older adults but evidence supporting vitamin D supplementation is variable in published literature, as most data comes from observational trials. New guidelines from the Endocrine Society focused on developing recommendations for healthy individuals with data obtained from randomized controlled trials (RCTs) and large longitudinal observational trials with comparison groups if RCTs were not available. These guidelines recommend against empiric supplementation of vitamin D for healthy adults aged 18-74, excluding pregnant women and patients with high-risk diabetes.³

For older adults aged 75 or greater, empiric vitamin D supplementation is recommended because of the possible reduction of risk in all-cause mortality in this population. Of note, this was a grade 2 recommendation by the panel, indicating that the benefits of the treatment probably outweigh the risks. The panel stated that vitamin D supplementation could be delivered through fortified foods, multivitamins with vitamin D, or as a separate vitamin D supplement.

The dosage should remain within the recommended daily allowance outlined by the Institute of Medicine of 800 IU daily for adults over 70, and the panel recommends low-dose daily vitamin D supplementation over high-dose interval supplementation. The panel noted that routine screening of vitamin D levels should not be used to guide decision-making on whether to start supplementation, but vitamin D levels should be obtained for patients who have an indication for evaluation.

The reviewers highlight that these guidelines were developed for healthy individuals and are not applicable to those with conditions that warrant vitamin D evaluation. In my clinical practice, many of my patients have bone-mineral conditions and cognitive impairment that warrant evaluation. Based on these guidelines, I will consider empiric vitamin D supplementation more often for healthy patients aged 75 and older.
 

Sedentary Behaviors and Healthy Aging

Engaging inactive older adults in regular physical activity can be challenging, particularly as the pandemic has led to more pervasive social isolation and affected the availability of in-person exercise activities in the community. Physical activity is a key component of healthy aging and cognition, and its benefits should be a part of routine counseling for older adults.

An interesting recent study published in JAMA Network Open by Shi et al. evaluated the association of health behaviors and aging in female US nurses over a 20-year period.⁴ Surveys were administered to capture time spent in each behavior, such as being sedentary (TV watching, sitting at home or at work), light activity (walking around the house or at work), and moderate to vigorous activity (walking for exercise, lawn mowing). “Healthy aging” was defined by the absence of chronic conditions such as heart failure, and lack of physical, mental, and cognitive impairment.

The study found that participants who were more sedentary were less likely to age healthfully, with each additional 2 hours of TV watching per day associated with a 12% reduction in likelihood of healthy aging. Light physical activity was associated with a significant increase in healthy aging, with a 6% increase in the likelihood of healthy aging for each additional 2 hours of light activity. Each additional 1 hour of moderate to vigorous activity was associated with a 14% increase in the likelihood of healthy aging. These findings support discussions with patients that behavior change, even in small increments, can be beneficial in healthy aging.
 

References

1. Xu W et al. Ann Intern Med. 2024 Jun;177(6):701-10.

2. Yourman LC et al. JAMA Intern Med. 2021;181:179-85.

3. Demay MB et al. J Clin Endocrinol Metab. August 2024;109(8):1907-47.

4. Shi H et al. JAMA Netw Open. 2024;7(6):e2416300.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Everyone takes a pharmacology class in medical school that includes a lecture on beta receptors. They’re in the heart (beta-1) and lungs (beta-2), and drug compounds agonize or antagonize one or both. The professor will caution against using antagonists (beta blockade) for patients with chronic obstructive pulmonary disease (COPD) lest they further impair the patient’s irreversibly narrowed airways. Obsequious students mature into obsequious doctors, intent on “doing no harm.” For better or worse, you withhold beta-blockers from your patient with COPD and comorbid cardiac disease.

Perhaps because the pulmonologist isn’t usually the one who decides whether a beta-blocker is prescribed, I’ve been napping on this topic since training. Early in fellowship, I read an ACP Journal Club article about a Cochrane systematic review (yes, I read a review of a review) that concluded that beta-blockers are fine in patients with COPD. The summary appealed to my bias towards evidence-based medicine (EBM) supplanting physiology, medical school, and everything else. I was more apt to believe my stodgy residency attendings than the stodgy pharmacology professor. Even though COPD and cardiovascular disease share multiple risk factors, I had never reinvestigated the relationship between beta-blockers and COPD.

Turns out that while I was sleeping, the debate continued. Go figure. Just last month a prospective, observational study published in JAMA Network Open found that beta-blockers did not increase the risk for cardiovascular or respiratory events among patients with COPD being discharged after hospitalization for acute myocardial infarction. Although this could be viewed as a triumph for EBM over physiology and a validation of my decade-plus of intellectual laziness, the results are actually pretty thin. These studies, in which patients with an indication for a therapy (a beta-blocker in this case) are analyzed by whether or not they received it, are problematic. The fanciest statistics — in this case, they used propensity scores — can’t control for residual confounding. What drove the physicians to prescribe in some cases but not others? We can only guess.

This might be okay if there hadn’t been a randomized controlled trial (RCT) published in 2019 in The New England Journal of Medicine that found that beta-blockers increase the risk for severe COPD exacerbations. In EBM, the RCT trumps all. Ironically, this trial was designed to test whether beta-blockers reduce severe COPD exacerbations. Yes, we’d come full circle. There was enough biologic plausibility to support a positive effect, or so thought the study authors and the Department of Defense (DOD) — for reasons I can’t possibly guess, the DOD funded this RCT. My pharmacology professor must be rolling over in his tenure.

The RCT did leave beta-blockers some wiggle room. The authors purposely excluded anyone with a cardiovascular indication for a beta-blocker. The intent was to ensure beneficial effects were isolated to respiratory and not cardiovascular outcomes. Of course, the reason I’m writing and you’re reading this is that COPD and cardiovascular disease co-occur at a high rate. The RCT notwithstanding, we prescribe beta-blockers to patients with COPD because they have a cardiac indication, not to reduce acute COPD exacerbations. So, it’s possible there’d be a net beta-blocker benefit in patients with COPD and comorbid heart disease.

That’s where the JAMA Network Open study comes in, but as discussed, methodologic weaknesses preclude its being the final word. That said, I think it’s unlikely we’ll see a COPD with comorbid cardiac disease RCT performed to assess whether beta-blockers provide a net benefit, unless maybe the DOD wants to fund another one of these. In the meantime, I’m calling clinical equipoise and punting. Fortunately for me, I don’t have to prescribe beta-blockers. I suppose I could consider stopping them in my patient with severe COPD, the one I can’t keep out of the hospital, but I’m not convinced that would make much difference.
 

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

Everyone takes a pharmacology class in medical school that includes a lecture on beta receptors. They’re in the heart (beta-1) and lungs (beta-2), and drug compounds agonize or antagonize one or both. The professor will caution against using antagonists (beta blockade) for patients with chronic obstructive pulmonary disease (COPD) lest they further impair the patient’s irreversibly narrowed airways. Obsequious students mature into obsequious doctors, intent on “doing no harm.” For better or worse, you withhold beta-blockers from your patient with COPD and comorbid cardiac disease.

Perhaps because the pulmonologist isn’t usually the one who decides whether a beta-blocker is prescribed, I’ve been napping on this topic since training. Early in fellowship, I read an ACP Journal Club article about a Cochrane systematic review (yes, I read a review of a review) that concluded that beta-blockers are fine in patients with COPD. The summary appealed to my bias towards evidence-based medicine (EBM) supplanting physiology, medical school, and everything else. I was more apt to believe my stodgy residency attendings than the stodgy pharmacology professor. Even though COPD and cardiovascular disease share multiple risk factors, I had never reinvestigated the relationship between beta-blockers and COPD.

Turns out that while I was sleeping, the debate continued. Go figure. Just last month a prospective, observational study published in JAMA Network Open found that beta-blockers did not increase the risk for cardiovascular or respiratory events among patients with COPD being discharged after hospitalization for acute myocardial infarction. Although this could be viewed as a triumph for EBM over physiology and a validation of my decade-plus of intellectual laziness, the results are actually pretty thin. These studies, in which patients with an indication for a therapy (a beta-blocker in this case) are analyzed by whether or not they received it, are problematic. The fanciest statistics — in this case, they used propensity scores — can’t control for residual confounding. What drove the physicians to prescribe in some cases but not others? We can only guess.

This might be okay if there hadn’t been a randomized controlled trial (RCT) published in 2019 in The New England Journal of Medicine that found that beta-blockers increase the risk for severe COPD exacerbations. In EBM, the RCT trumps all. Ironically, this trial was designed to test whether beta-blockers reduce severe COPD exacerbations. Yes, we’d come full circle. There was enough biologic plausibility to support a positive effect, or so thought the study authors and the Department of Defense (DOD) — for reasons I can’t possibly guess, the DOD funded this RCT. My pharmacology professor must be rolling over in his tenure.

The RCT did leave beta-blockers some wiggle room. The authors purposely excluded anyone with a cardiovascular indication for a beta-blocker. The intent was to ensure beneficial effects were isolated to respiratory and not cardiovascular outcomes. Of course, the reason I’m writing and you’re reading this is that COPD and cardiovascular disease co-occur at a high rate. The RCT notwithstanding, we prescribe beta-blockers to patients with COPD because they have a cardiac indication, not to reduce acute COPD exacerbations. So, it’s possible there’d be a net beta-blocker benefit in patients with COPD and comorbid heart disease.

That’s where the JAMA Network Open study comes in, but as discussed, methodologic weaknesses preclude its being the final word. That said, I think it’s unlikely we’ll see a COPD with comorbid cardiac disease RCT performed to assess whether beta-blockers provide a net benefit, unless maybe the DOD wants to fund another one of these. In the meantime, I’m calling clinical equipoise and punting. Fortunately for me, I don’t have to prescribe beta-blockers. I suppose I could consider stopping them in my patient with severe COPD, the one I can’t keep out of the hospital, but I’m not convinced that would make much difference.
 

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

Everyone takes a pharmacology class in medical school that includes a lecture on beta receptors. They’re in the heart (beta-1) and lungs (beta-2), and drug compounds agonize or antagonize one or both. The professor will caution against using antagonists (beta blockade) for patients with chronic obstructive pulmonary disease (COPD) lest they further impair the patient’s irreversibly narrowed airways. Obsequious students mature into obsequious doctors, intent on “doing no harm.” For better or worse, you withhold beta-blockers from your patient with COPD and comorbid cardiac disease.

Perhaps because the pulmonologist isn’t usually the one who decides whether a beta-blocker is prescribed, I’ve been napping on this topic since training. Early in fellowship, I read an ACP Journal Club article about a Cochrane systematic review (yes, I read a review of a review) that concluded that beta-blockers are fine in patients with COPD. The summary appealed to my bias towards evidence-based medicine (EBM) supplanting physiology, medical school, and everything else. I was more apt to believe my stodgy residency attendings than the stodgy pharmacology professor. Even though COPD and cardiovascular disease share multiple risk factors, I had never reinvestigated the relationship between beta-blockers and COPD.

Turns out that while I was sleeping, the debate continued. Go figure. Just last month a prospective, observational study published in JAMA Network Open found that beta-blockers did not increase the risk for cardiovascular or respiratory events among patients with COPD being discharged after hospitalization for acute myocardial infarction. Although this could be viewed as a triumph for EBM over physiology and a validation of my decade-plus of intellectual laziness, the results are actually pretty thin. These studies, in which patients with an indication for a therapy (a beta-blocker in this case) are analyzed by whether or not they received it, are problematic. The fanciest statistics — in this case, they used propensity scores — can’t control for residual confounding. What drove the physicians to prescribe in some cases but not others? We can only guess.

This might be okay if there hadn’t been a randomized controlled trial (RCT) published in 2019 in The New England Journal of Medicine that found that beta-blockers increase the risk for severe COPD exacerbations. In EBM, the RCT trumps all. Ironically, this trial was designed to test whether beta-blockers reduce severe COPD exacerbations. Yes, we’d come full circle. There was enough biologic plausibility to support a positive effect, or so thought the study authors and the Department of Defense (DOD) — for reasons I can’t possibly guess, the DOD funded this RCT. My pharmacology professor must be rolling over in his tenure.

The RCT did leave beta-blockers some wiggle room. The authors purposely excluded anyone with a cardiovascular indication for a beta-blocker. The intent was to ensure beneficial effects were isolated to respiratory and not cardiovascular outcomes. Of course, the reason I’m writing and you’re reading this is that COPD and cardiovascular disease co-occur at a high rate. The RCT notwithstanding, we prescribe beta-blockers to patients with COPD because they have a cardiac indication, not to reduce acute COPD exacerbations. So, it’s possible there’d be a net beta-blocker benefit in patients with COPD and comorbid heart disease.

That’s where the JAMA Network Open study comes in, but as discussed, methodologic weaknesses preclude its being the final word. That said, I think it’s unlikely we’ll see a COPD with comorbid cardiac disease RCT performed to assess whether beta-blockers provide a net benefit, unless maybe the DOD wants to fund another one of these. In the meantime, I’m calling clinical equipoise and punting. Fortunately for me, I don’t have to prescribe beta-blockers. I suppose I could consider stopping them in my patient with severe COPD, the one I can’t keep out of the hospital, but I’m not convinced that would make much difference.
 

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can: 

• Decrease blood pressure by increasing urinary excretion of sodium
• Improve nephrolithiasis by decreasing urinary excretion of calcium
• Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
• Increase bone density in postmenopausal women
• Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

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

Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can: 

• Decrease blood pressure by increasing urinary excretion of sodium
• Improve nephrolithiasis by decreasing urinary excretion of calcium
• Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
• Increase bone density in postmenopausal women
• Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

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

Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can: 

• Decrease blood pressure by increasing urinary excretion of sodium
• Improve nephrolithiasis by decreasing urinary excretion of calcium
• Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
• Increase bone density in postmenopausal women
• Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

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

The role of body mass index (BMI) in defining obesity and the definition of obesity as a disease merit reevaluation to avoid unintended consequences, experts said in three new opinion papers.

The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.

And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.

Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”

Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
 

BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’

In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”

They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.

Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”

They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.

Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”

Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.

That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
 

Does Calling Obesity a ‘Disease’ Have Unintended Consequences?

In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”

Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.

Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”

Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.

Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”

Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”

Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
 

Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?

Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m² and 27.5 kg/m² or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.

Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m² in India to 28 kg/m² in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.

The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m² in South Asian populations, 26.6 kg/m² in Arab populations, 26.9 kg/m² in Chinese populations, and 28.1 kg/m² in Black populations.

These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.

They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.

Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”

Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”

Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
 

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

The role of body mass index (BMI) in defining obesity and the definition of obesity as a disease merit reevaluation to avoid unintended consequences, experts said in three new opinion papers.

The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.

And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.

Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”

Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
 

BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’

In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”

They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.

Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”

They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.

Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”

Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.

That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
 

Does Calling Obesity a ‘Disease’ Have Unintended Consequences?

In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”

Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.

Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”

Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.

Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”

Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”

Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
 

Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?

Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m² and 27.5 kg/m² or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.

Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m² in India to 28 kg/m² in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.

The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m² in South Asian populations, 26.6 kg/m² in Arab populations, 26.9 kg/m² in Chinese populations, and 28.1 kg/m² in Black populations.

These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.

They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.

Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”

Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”

Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
 

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

The role of body mass index (BMI) in defining obesity and the definition of obesity as a disease merit reevaluation to avoid unintended consequences, experts said in three new opinion papers.

The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.

And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.

Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”

Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
 

BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’

In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”

They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.

Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”

They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.

Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”

Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.

That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
 

Does Calling Obesity a ‘Disease’ Have Unintended Consequences?

In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”

Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.

Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”

Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.

Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”

Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”

Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
 

Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?

Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m² and 27.5 kg/m² or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.

Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m² in India to 28 kg/m² in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.

The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m² in South Asian populations, 26.6 kg/m² in Arab populations, 26.9 kg/m² in Chinese populations, and 28.1 kg/m² in Black populations.

These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.

They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.

Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”

Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”

Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
 

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

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

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

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

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

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

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