Feature

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

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

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

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

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

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

In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision. 

The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice? 

Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.

“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor. 

The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47. 

A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.

A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities. 
 

Causation or Coincidence?

The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain. 

A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor. 

“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said. 

For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said. 

Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.

She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”

A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms. 
 

Clear Clinical Implications 

Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care. 

“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted. 

Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.

In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.

“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.

“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.

The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated. 

“A clear opportunity for dementia prevention exists with treatment of visual loss,” the report concluded.

Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision. 

The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice? 

Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.

“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor. 

The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47. 

A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.

A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities. 
 

Causation or Coincidence?

The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain. 

A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor. 

“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said. 

For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said. 

Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.

She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”

A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms. 
 

Clear Clinical Implications 

Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care. 

“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted. 

Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.

In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.

“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.

“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.

The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated. 

“A clear opportunity for dementia prevention exists with treatment of visual loss,” the report concluded.

Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision. 

The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice? 

Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.

“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor. 

The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47. 

A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.

A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities. 
 

Causation or Coincidence?

The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain. 

A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor. 

“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said. 

For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said. 

Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.

She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”

A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms. 
 

Clear Clinical Implications 

Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care. 

“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted. 

Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.

In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.

“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.

“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.

The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated. 

“A clear opportunity for dementia prevention exists with treatment of visual loss,” the report concluded.

Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

This transcript has been edited for clarity. 

I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.

I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.

These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.

The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.

We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism. 

In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
 

Stroke, Smoking, and Alcohol

A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.

You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.

In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing. 

Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.

A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.

There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing. 
 

Parkinson’s Disease

Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease. 

Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors. 

A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.

The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy. 

These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.

If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.

Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases. In the next 5 years, we will learn whether GLP-1 or GIP/GLP-1 receptor agonists are the new wonder drugs in medicine.
 

Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
 

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

This transcript has been edited for clarity. 

I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.

I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.

These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.

The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.

We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism. 

In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
 

Stroke, Smoking, and Alcohol

A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.

You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.

In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing. 

Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.

A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.

There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing. 
 

Parkinson’s Disease

Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease. 

Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors. 

A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.

The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy. 

These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.

If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.

Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases. In the next 5 years, we will learn whether GLP-1 or GIP/GLP-1 receptor agonists are the new wonder drugs in medicine.
 

Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
 

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

This transcript has been edited for clarity. 

I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.

I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.

These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.

The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.

We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism. 

In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
 

Stroke, Smoking, and Alcohol

A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.

You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.

In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing. 

Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.

A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.

There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing. 
 

Parkinson’s Disease

Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease. 

Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors. 

A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.

The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy. 

These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.

If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.

Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases. In the next 5 years, we will learn whether GLP-1 or GIP/GLP-1 receptor agonists are the new wonder drugs in medicine.
 

Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
 

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

The Food and Drug Administration (FDA) has approved durvalumab (Imfinzi; AstraZeneca) both before and after surgery in patients with resectable non–small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.

The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary. 

Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery. 

The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer. 

AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year. 

The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release. 

Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment. 

The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg. 

Durvalumab costs around $1,053 for 120 mg, according to drugs.com.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved durvalumab (Imfinzi; AstraZeneca) both before and after surgery in patients with resectable non–small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.

The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary. 

Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery. 

The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer. 

AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year. 

The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release. 

Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment. 

The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg. 

Durvalumab costs around $1,053 for 120 mg, according to drugs.com.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved durvalumab (Imfinzi; AstraZeneca) both before and after surgery in patients with resectable non–small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.

The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary. 

Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery. 

The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer. 

AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year. 

The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release. 

Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment. 

The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg. 

Durvalumab costs around $1,053 for 120 mg, according to drugs.com.

A version of this article appeared on Medscape.com.

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

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

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

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

BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies. 

Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast. 

However, men often fly under the radar. 

Although males represent half of BRCA1/2 pathogenic variant carriers, men are much less likely to receive genetic testing for BRCA mutations. “Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers. 

The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.

A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai. 

Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said. 
 

BRCA Mutations in Men: What’s the Risk? 

Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers. 

BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.

For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.

Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%. 
 

When to Test, When to Screen?

Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.

BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization. 

For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.

Even for confirmed BRCA carriers, cancer screening guidelines for men vary.

For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family. 

Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening. 

The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.

The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review. 

For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.

And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.

A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”

To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.

Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.

Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
 

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

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

In a bid to reduce stigma and improve treatment rates, a small group of clinicians, as well as military personnel, is lobbying the American Psychiatric Association (APA) to change the name of posttraumatic stress disorder (PTSD) to posttraumatic stress injury (PTSI) for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.

Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.

The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.

“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”

Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
 

Neurobiology of Trauma

Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.

Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”

This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.

The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.

“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.

He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
 

A Natural Response, Not a Disorder

Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.

In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.

Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.

“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.

This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”

The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.

However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.

A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.

Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.

Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.

“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
 

A Barrier to Care

Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.

Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.

Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”

Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”

Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”

Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
 

‘An Avenue for Dignity’

Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.

There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”

If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”

Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”

Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”

By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.

Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”

While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”

Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.

Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

In a bid to reduce stigma and improve treatment rates, a small group of clinicians, as well as military personnel, is lobbying the American Psychiatric Association (APA) to change the name of posttraumatic stress disorder (PTSD) to posttraumatic stress injury (PTSI) for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.

Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.

The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.

“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”

Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
 

Neurobiology of Trauma

Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.

Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”

This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.

The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.

“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.

He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
 

A Natural Response, Not a Disorder

Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.

In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.

Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.

“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.

This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”

The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.

However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.

A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.

Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.

Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.

“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
 

A Barrier to Care

Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.

Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.

Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”

Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”

Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”

Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
 

‘An Avenue for Dignity’

Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.

There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”

If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”

Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”

Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”

By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.

Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”

While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”

Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.

Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

In a bid to reduce stigma and improve treatment rates, a small group of clinicians, as well as military personnel, is lobbying the American Psychiatric Association (APA) to change the name of posttraumatic stress disorder (PTSD) to posttraumatic stress injury (PTSI) for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.

Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.

The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.

“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”

Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
 

Neurobiology of Trauma

Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.

Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”

This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.

The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.

“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.

He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
 

A Natural Response, Not a Disorder

Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.

In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.

Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.

“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.

This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”

The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.

However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.

A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.

Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.

Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.

“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
 

A Barrier to Care

Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.

Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.

Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”

Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”

Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”

Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
 

‘An Avenue for Dignity’

Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.

There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”

If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”

Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”

Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”

By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.

Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”

While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”

Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.

Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

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

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

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

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

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

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

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

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

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

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

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